<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03235804</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00070712</org_study_id>
    <nct_id>NCT03235804</nct_id>
  </id_info>
  <brief_title>The Impact of a Powdered Meal Replacement on Metabolism and Gut Microbiota</brief_title>
  <acronym>PREMIUM</acronym>
  <official_title>The Impact of a Powdered Meal Replacement on Metabolism and Gut Microbiota: a 12-week Study in Individuals With Excessive Body Weight</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Almased Wellness GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will investigate the impact of a 12-week powdered meal replacement on&#xD;
      inflammatory, metabolic, and hormonal markers of obesity-associated conditions and to&#xD;
      correlate this response to compositional shifts within the gut microbiota. Moreover, resting&#xD;
      energy expenditure, body composition, appetite sensations and soy metabolomics will be&#xD;
      explored.&#xD;
&#xD;
      This study will be a randomized, parallel group, clinical trial of a 12-week nutritional&#xD;
      intervention. A sample size of n=88 participants will be randomly allocated into one of the&#xD;
      following groups:&#xD;
&#xD;
        -  Control group (CON): Participants will be asked to maintain their usual dietary intake&#xD;
           over 12 weeks. Their usual dietary intake is expected to reflect the North American&#xD;
           dietary pattern (i.e. ~15% of total energy intake coming from protein, ~50% from&#xD;
           carbohydrate and ~35% from fat).&#xD;
&#xD;
        -  Powdered Meal Replacement group (PMR): Participants will be asked to maintain their&#xD;
           usual dietary intake and consume a powdered meal replacement composed of soy protein,&#xD;
           honey and yogurt twice daily (in two snacks) over 12 weeks. The addition of the meal&#xD;
           replacement to a North American Dietary Pattern (described on the CON group diet) will&#xD;
           result in a diet composed of, approximately, 22% of protein, 48% of carbohydrate and 30%&#xD;
           of fat of total energy intake.&#xD;
&#xD;
      The following variables will be analyzed:&#xD;
&#xD;
        -  Interleukin (IL)-6.&#xD;
&#xD;
        -  Gut microbiota diversity and composition, specifically taxa that have been associated&#xD;
           with health benefits, obesity, and weight loss.&#xD;
&#xD;
        -  Systemic inflammatory biomarkers (high-sensitivity C-reactive protein, IL-8, IL-10 and&#xD;
           tumor necrosis factor-α);&#xD;
&#xD;
        -  Metabolic blood markers (glucose, insulin, lipid panel, peptide tyrosine-tyrosine,&#xD;
           glucagon-like peptide-1, ghrelin, adiponectin, leptin, free glycerol, free fatty acids,&#xD;
           and thyroid stimulating hormone)&#xD;
&#xD;
        -  Resting energy expenditure;&#xD;
&#xD;
        -  Body composition;&#xD;
&#xD;
        -  Appetite sensations (hunger, satiety, fullness, and prospective food consumption);&#xD;
&#xD;
        -  Soy polyphenols' metabolomics.&#xD;
&#xD;
        -  Gene expression and genetic polymorphisms. At baseline and after 6 and 12 weeks,&#xD;
           individuals will attend our Human Nutrition Research Unit where all assessments will&#xD;
           take place. In order to assess participants' adherence and follow-up, dietary intake,&#xD;
           body weight and appetite sensations (only for participants assigned to the PMR group)&#xD;
           will be assessed weekly during the 12-week intervention period. Additionally,&#xD;
           participants will be contacted by phone weekly and reminded to maintain their&#xD;
           journal/log.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Overweight and obesity increase the risk of developing several diseases having a negative&#xD;
      effect on people's health. The prevalence of these conditions is increasing worldwide, but&#xD;
      successful treatments are lacking. As excess body weight is a result of an imbalance between&#xD;
      calories in and calories out, dietary intake plays an important role in maintaining a healthy&#xD;
      body weight and overall health status. Meal replacements are nutritionally complete formula&#xD;
      foods used to substitute a meal. They can be a drink, bar, or soup. These products have been&#xD;
      gaining popularity because they can help individuals lose weight. In addition, depending on&#xD;
      its ingredients, meal replacements may affect our health. For this reason, meal replacements&#xD;
      have been studied for health benefits. However, how meal replacements affect the microbes&#xD;
      living in our gut, inflammation, and our genes is not known. Well-designed studies using&#xD;
      state-of-the-art equipment can help elucidate the mechanisms by meal replacements act in&#xD;
      individuals with overweight or obesity.&#xD;
&#xD;
      The overall purpose of this research is to investigate the impact of a 12-week powdered meal&#xD;
      replacement on inflammatory, metabolic, and hormonal markers of obesity-associated conditions&#xD;
      and to correlate this response to compositional shifts within the gut microbiota. Moreover,&#xD;
      resting energy expenditure, body composition, appetite sensations, soy metabolomics, gene&#xD;
      expression, and genetic polymorphisms will be explored.&#xD;
&#xD;
      This study will be a randomized, parallel group, clinical trial of a 12-week nutritional&#xD;
      intervention. A sample size of n=88 participants will be randomly allocated into one of the&#xD;
      following groups:&#xD;
&#xD;
        -  Control group (CON): Participants will be asked to maintain their usual dietary intake&#xD;
           over 12 weeks. Participants' usual dietary intake is expected to reflect the North&#xD;
           American dietary pattern (i.e. ~15% of total energy intake coming from protein, ~50%&#xD;
           from carbohydrate and ~35% from fat).&#xD;
&#xD;
        -  Powdered Meal Replacement group (PMR): Participants will be asked to maintain their&#xD;
           usual dietary intake and consume a powdered meal replacement composed of soy protein,&#xD;
           honey and yogurt twice daily (in two snacks) over 12 weeks. The addition of the&#xD;
           nutritional supplement to a North American Dietary Pattern (described on the CON group&#xD;
           diet) will result in a diet composed of, approximately, 22% of protein, 48% of&#xD;
           carbohydrate and 30% of fat of total energy intake. The amount of protein is considered&#xD;
           higher than the North American dietary pattern (i.e. 15%); however, still within the&#xD;
           Acceptable Macronutrient Distribution Range (AMDR) recommended by the Dietary Guidelines&#xD;
           for Americans (10-35%).&#xD;
&#xD;
      The following variables will be analyzed:&#xD;
&#xD;
        -  Interleukin (IL)-6.&#xD;
&#xD;
        -  Gut microbiota diversity and composition, specifically taxa that have been associated&#xD;
           with health benefits, obesity, and weight loss.&#xD;
&#xD;
        -  Systemic inflammatory biomarkers (high-sensitivity C-reactive protein [hs-CRP], IL-8,&#xD;
           IL-10 and tumor necrosis factor-α [TNF-α]);&#xD;
&#xD;
        -  Metabolic blood markers [glucose, insulin, lipid panel (i.e. total cholesterol, LDL,&#xD;
           HDL, and triglycerides), peptide tyrosine-tyrosine (PYY), glucagon-like peptide-1&#xD;
           (GLP-1), ghrelin, adiponectin, leptin, free glycerol, free fatty acids, and thyroid&#xD;
           stimulating hormone (TSH)];&#xD;
&#xD;
        -  Resting energy expenditure;&#xD;
&#xD;
        -  Body composition;&#xD;
&#xD;
        -  Appetite sensations (hunger, satiety, fullness, and prospective food consumption);&#xD;
&#xD;
        -  Soy polyphenols' metabolomics.&#xD;
&#xD;
        -  Gene expression and genetic polymorphisms. At baseline and after 6 and 12 weeks,&#xD;
           individuals will attend our Human Nutrition Research Unit where all assessments will&#xD;
           take place. In order to assess participants' adherence and follow-up, dietary intake,&#xD;
           body weight and appetite sensations will be assessed weekly during the 12-week&#xD;
           intervention period. Additionally, participants will be contacted by phone weekly and&#xD;
           reminded to maintain their journal/log. Dietary intake will be assessed by a 3-day&#xD;
           dietary record (2 week days and 1 weekend day) at baseline, at mid-point and end of the&#xD;
           study. Participants will also be asked to complete a 1-day dietary record on one&#xD;
           weekday, each week of the study. The purpose of this regular assessment is to avoid&#xD;
           daily fluctuations in eating patterns, also ensuring a personalized feedback for those&#xD;
           experiencing weight fluctuations. Both of these assessments (i.e. 1-day and 3-day&#xD;
           dietary records) will be conducted using the online Automated Self -Administered 24-hour&#xD;
           Recall (ASA24) Canada. The ASA24 is a validated web-based program that uses the&#xD;
           validated U.S. Department of Agriculture's Automated Multiple-Pass Method, and is&#xD;
           modified to support the Canadian food supply.&#xD;
&#xD;
      Participants will receive a digital scale and will be asked to weight themselves daily.&#xD;
      Participants from the PMR group will also be asked to rate their appetite sensations on a&#xD;
      100-mm VAS paper sheet. Appetite sensation should be completed in the morning (after waking&#xD;
      up and while fasting) and 30 minutes after consuming the supplement snacks in order to assess&#xD;
      hunger, satiety, fullness, and prospective food consumption.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Anticipated">November 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Interleukin-6.</measure>
    <time_frame>At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).</time_frame>
    <description>Changes in blood interleukin-6 will be assessed at baseline, middle and end of the 12-week dietary intervention period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gut microbiota diversity and composition.</measure>
    <time_frame>At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).</time_frame>
    <description>Changes in gut microbiome diversity and composition (specifically taxa that have been associated with health benefits, obesity and weight loss) will be assessed at baseline, middle and end of the 12-week dietary intervention period.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>High-sensitivity C-reactive protein.</measure>
    <time_frame>At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).</time_frame>
    <description>Changes in blood high-sensitivity C-reactive protein will be assessed at baseline, middle and end of the 12-week dietary intervention period.</description>
  </other_outcome>
  <other_outcome>
    <measure>Interleukin 8.</measure>
    <time_frame>At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).</time_frame>
    <description>Changes in interleukin 8 will be assessed at baseline, middle and end of the 12-week dietary intervention period.</description>
  </other_outcome>
  <other_outcome>
    <measure>Interleukin 10.</measure>
    <time_frame>At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).</time_frame>
    <description>Changes in interleukin 10 will be assessed at baseline, middle and end of the 12-week dietary intervention period.</description>
  </other_outcome>
  <other_outcome>
    <measure>Tumor necrosis factor-α.</measure>
    <time_frame>At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).</time_frame>
    <description>Changes in tumor necrosis factor-α will be assessed at baseline, middle and end of the 12-week dietary intervention period.</description>
  </other_outcome>
  <other_outcome>
    <measure>Adiponectin.</measure>
    <time_frame>At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).</time_frame>
    <description>Changes in adiponectin will be assessed at baseline, middle and end of the 12-week dietary intervention period.</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood glucose.</measure>
    <time_frame>At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).</time_frame>
    <description>Changes in blood glucose will be assessed at baseline, middle and end of the 12-week dietary intervention period.</description>
  </other_outcome>
  <other_outcome>
    <measure>Insulin.</measure>
    <time_frame>At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).</time_frame>
    <description>Changes in insulin will be assessed at baseline, middle and end of the 12-week dietary intervention period.</description>
  </other_outcome>
  <other_outcome>
    <measure>Lipid panel.</measure>
    <time_frame>At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).</time_frame>
    <description>Changes in lipid panel (i.e. total cholesterol, LDL, HDL and triglycerides) will be assessed at baseline, middle and end of the 12-week dietary intervention period.</description>
  </other_outcome>
  <other_outcome>
    <measure>Peptide tyrosine-tyrosine.</measure>
    <time_frame>At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).</time_frame>
    <description>Changes in peptide tyrosine-tyrosine will be assessed at baseline, middle and end of the 12-week dietary intervention period.</description>
  </other_outcome>
  <other_outcome>
    <measure>Glucagon-like peptide 1.</measure>
    <time_frame>At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).</time_frame>
    <description>Changes in glucagon-like peptide-1 will be assessed at baseline, middle and end of the 12-week dietary intervention period.</description>
  </other_outcome>
  <other_outcome>
    <measure>Ghrelin.</measure>
    <time_frame>At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).</time_frame>
    <description>Changes in ghrelin will be assessed at baseline, middle and end of the 12-week dietary intervention period.</description>
  </other_outcome>
  <other_outcome>
    <measure>Leptin.</measure>
    <time_frame>At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).</time_frame>
    <description>Changes in leptin will be assessed at baseline, middle and end of the 12-week dietary intervention period.</description>
  </other_outcome>
  <other_outcome>
    <measure>Free glycerol.</measure>
    <time_frame>At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).</time_frame>
    <description>Changes free glycerol will be assessed at baseline, middle and end of the 12-week dietary intervention period.</description>
  </other_outcome>
  <other_outcome>
    <measure>Free fatty acids.</measure>
    <time_frame>At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).</time_frame>
    <description>Changes in free fatty acids will be assessed at baseline, middle and end of the 12-week dietary intervention period.</description>
  </other_outcome>
  <other_outcome>
    <measure>Thyroid stimulating hormone.</measure>
    <time_frame>At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).</time_frame>
    <description>Changes in thyroid stimulating hormone will be assessed at baseline, middle and end of the 12-week dietary intervention period.</description>
  </other_outcome>
  <other_outcome>
    <measure>Resting energy expenditure.</measure>
    <time_frame>At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).</time_frame>
    <description>Changes in resting energy expenditure will be assessed at baseline, middle and end of the 12-week dietary intervention period using a whole body calorimetry unit.</description>
  </other_outcome>
  <other_outcome>
    <measure>Body composition.</measure>
    <time_frame>At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).</time_frame>
    <description>Changes in fat mass, lean soft tissue and bone mineral content will be assessed at baseline, middle and end of the 12-week dietary intervention period using dual-energy X-ray absorptiometry.</description>
  </other_outcome>
  <other_outcome>
    <measure>Appetite sensations.</measure>
    <time_frame>Once per week during the intervention period (12 weeks).</time_frame>
    <description>Changes in hunger, satiety, fullness, and prospective food consumption will be assessed weekly using a 100 mm visual analogue scale.</description>
  </other_outcome>
  <other_outcome>
    <measure>Soy polyphenols' metabolomics.</measure>
    <time_frame>At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).</time_frame>
    <description>Soy polyphenols' metabolomics will be assessed on participants assigned to the 12-week dietary intervention periodPowdered Meal Replacement group at baseline, middle and end of the 12-week dietary intervention period using blood and urine samples.</description>
  </other_outcome>
  <other_outcome>
    <measure>Gene expression</measure>
    <time_frame>At baseline (week 1) and end (week 12) of the intervention period (12 weeks).</time_frame>
    <description>Changes in gene expression will be assessed at baseline and at the end of the 12-week dietary intervention period</description>
  </other_outcome>
  <other_outcome>
    <measure>Genetic polymorphisms</measure>
    <time_frame>At baseline (week 1)</time_frame>
    <description>Genetic polymorphisms will be identified at baseline</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">88</enrollment>
  <condition>Dietary Modification</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Those assigned to the Control group will be asked to maintain their usual dietary intake over 12 weeks. Participants' usual dietary intake is expected to reflect the North American dietary pattern (i.e. ~15% of total energy intake coming from protein, ~50% from carbohydrate and ~35% from fat).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Powdered Meal Replacement Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Those assigned to the Powdered Meal Replacement group will be asked to maintain their usual dietary intake and consume a powdered meal replacement composed of soy protein, honey and yogurt twice daily (in two snacks) over 12 weeks. The addition of the nutritional supplement to a North American Dietary Pattern (described on the CON group diet) will result in a diet composed of, approximately, 22% of protein, 48% of carbohydrate and 30% of fat of total energy intake. The amount of protein is considered higher than the North American dietary pattern (i.e. 15%); however, still within the Acceptable Macronutrient Distribution Range (AMDR) recommended by the Dietary Guidelines for Americans (10-35%).</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Soy protein, honey and yogurt.</intervention_name>
    <description>Participants will be asked to maintain their usual dietary intake and consume a powdered meal replacement composed of soy protein, honey and yogurt twice daily (in two snacks) over 12 weeks. The addition of the nutritional supplement to a North American Dietary Pattern (described on the CON group diet) will result in a diet composed of, approximately, 22% of protein, 48% of carbohydrate and 30% of fat of total energy intake. The amount of protein is considered higher than the North American dietary pattern (i.e. 15%); however, still within the Acceptable Macronutrient Distribution Range (AMDR) recommended by the Dietary Guidelines for Americans (10-35%).</description>
    <arm_group_label>Powdered Meal Replacement Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-smoker;&#xD;
&#xD;
          -  Female/Male;&#xD;
&#xD;
          -  Aged 18 to 50 years;&#xD;
&#xD;
          -  Body mass index (BMI) between 25 and 37 kg/m²;&#xD;
&#xD;
          -  Weight stable (&lt; ± 5 kg over past 6 months);&#xD;
&#xD;
          -  Fat mass ≥20% for men and ≥25% for women;&#xD;
&#xD;
          -  Maintaining current levels of physical activity throughout the study.&#xD;
&#xD;
          -  Female participants must verify use of acceptable, effective birth control methods&#xD;
             (total abstinence, hormonal birth control [oral, injectable, transdermal,&#xD;
             intravaginal], intrauterine devices, confirmed successful vasectomy or partner, or&#xD;
             condoms).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of chronic diseases or acute infections;&#xD;
&#xD;
          -  Taking any medication that may alter inflammation, energy metabolism, body weight and&#xD;
             composition, gut microbiota and hormone levels; investigators should always be&#xD;
             informed if there are any changes in medications or Natural health product use;&#xD;
&#xD;
          -  Taking pre- and probiotics (e.g. supplements);&#xD;
&#xD;
          -  Use of antibiotics in the past two months;&#xD;
&#xD;
          -  Use of thyroid replacement therapy;&#xD;
&#xD;
          -  Use of nutritional supplements in the past four weeks (multivitamin and vitamin D3 are&#xD;
             permitted to be used during the course of the study);&#xD;
&#xD;
          -  Allergy to any ingredient (including non-medicinal ingredients) in investigational&#xD;
             product;&#xD;
&#xD;
          -  Lactose, gluten and/or soy allergic/intolerant;&#xD;
&#xD;
          -  Follow a vegetarian, vegan or any restrictive dietary pattern;&#xD;
&#xD;
          -  Pregnant or lactating;&#xD;
&#xD;
          -  Perform over three hours of vigorous physical activity per week;&#xD;
&#xD;
          -  A nuclear medicine scan or injection of an X-ray dye in the past week;&#xD;
&#xD;
          -  A barium test/exam in the last two weeks;&#xD;
&#xD;
          -  Suffer from claustrophobia;&#xD;
&#xD;
          -  Inability to comprehend and complete the required questionnaires.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jens Walter, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carla M Prado, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Arya Sharma, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Julia Montenegro, MSc</last_name>
    <phone>(780) 492-7820</phone>
    <email>premium@ualberta.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Human Nutrition Research Unit</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carla M Prado, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>July 4, 2023</last_update_submitted>
  <last_update_submitted_qc>July 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Powdered meal replacement</keyword>
  <keyword>Inflammation</keyword>
  <keyword>Gut microbiota</keyword>
  <keyword>Energy metabolism</keyword>
  <keyword>Body composition</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03235804
org study id: Pro00070712
nct id: NCT03235804
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will investigate the impact of a 12-week powdered meal replacement on
      inflammatory, metabolic, and hormonal markers of obesity-associated conditions and to
      correlate this response to compositional shifts within the gut microbiota. Moreover, resting
      energy expenditure, body composition, appetite sensations and soy metabolomics will be
      explored.

      This study will be a randomized, parallel group, clinical trial of a 12-week nutritional
      intervention. A sample size of n=88 participants will be randomly allocated into one of the
      following groups:

        -  Control group (CON): Participants will be asked to maintain their usual dietary intake
           over 12 weeks. Their usual dietary intake is expected to reflect the North American
           dietary pattern (i.e. ~15% of total energy intake coming from protein, ~50% from
           carbohydrate and ~35% from fat).

        -  Powdered Meal Replacement group (PMR): Participants will be asked to maintain their
           usual dietary intake and consume a powdered meal replacement composed of soy protein,
           honey and yogurt twice daily (in two snacks) over 12 weeks. The addition of the meal
           replacement to a North American Dietary Pattern (described on the CON group diet) will
           result in a diet composed of, approximately, 22% of protein, 48% of carbohydrate and 30%
           of fat of total energy intake.

      The following variables will be analyzed:

        -  Interleukin (IL)-6.

        -  Gut microbiota diversity and composition, specifically taxa that have been associated
           with health benefits, obesity, and weight loss.

        -  Systemic inflammatory biomarkers (high-sensitivity C-reactive protein, IL-8, IL-10 and
           tumor necrosis factor-α);

        -  Metabolic blood markers (glucose, insulin, lipid panel, peptide tyrosine-tyrosine,
           glucagon-like peptide-1, ghrelin, adiponectin, leptin, free glycerol, free fatty acids,
           and thyroid stimulating hormone)

        -  Resting energy expenditure;

        -  Body composition;

        -  Appetite sensations (hunger, satiety, fullness, and prospective food consumption);

        -  Soy polyphenols' metabolomics.

        -  Gene expression and genetic polymorphisms. At baseline and after 6 and 12 weeks,
           individuals will attend our Human Nutrition Research Unit where all assessments will
           take place. In order to assess participants' adherence and follow-up, dietary intake,
           body weight and appetite sensations (only for participants assigned to the PMR group)
           will be assessed weekly during the 12-week intervention period. Additionally,
           participants will be contacted by phone weekly and reminded to maintain their
           journal/log.
Overweight and obesity increase the risk of developing several diseases having a negative
      effect on people's health. The prevalence of these conditions is increasing worldwide, but
      successful treatments are lacking. As excess body weight is a result of an imbalance between
      calories in and calories out, dietary intake plays an important role in maintaining a healthy
      body weight and overall health status. Meal replacements are nutritionally complete formula
      foods used to substitute a meal. They can be a drink, bar, or soup. These products have been
      gaining popularity because they can help individuals lose weight. In addition, depending on
      its ingredients, meal replacements may affect our health. For this reason, meal replacements
      have been studied for health benefits. However, how meal replacements affect the microbes
      living in our gut, inflammation, and our genes is not known. Well-designed studies using
      state-of-the-art equipment can help elucidate the mechanisms by meal replacements act in
      individuals with overweight or obesity.

      The overall purpose of this research is to investigate the impact of a 12-week powdered meal
      replacement on inflammatory, metabolic, and hormonal markers of obesity-associated conditions
      and to correlate this response to compositional shifts within the gut microbiota. Moreover,
      resting energy expenditure, body composition, appetite sensations, soy metabolomics, gene
      expression, and genetic polymorphisms will be explored.

      This study will be a randomized, parallel group, clinical trial of a 12-week nutritional
      intervention. A sample size of n=88 participants will be randomly allocated into one of the
      following groups:

        -  Control group (CON): Participants will be asked to maintain their usual dietary intake
           over 12 weeks. Participants' usual dietary intake is expected to reflect the North
           American dietary pattern (i.e. ~15% of total energy intake coming from protein, ~50%
           from carbohydrate and ~35% from fat).

        -  Powdered Meal Replacement group (PMR): Participants will be asked to maintain their
           usual dietary intake and consume a powdered meal replacement composed of soy protein,
           honey and yogurt twice daily (in two snacks) over 12 weeks. The addition of the
           nutritional supplement to a North American Dietary Pattern (described on the CON group
           diet) will result in a diet composed of, approximately, 22% of protein, 48% of
           carbohydrate and 30% of fat of total energy intake. The amount of protein is considered
           higher than the North American dietary pattern (i.e. 15%); however, still within the
           Acceptable Macronutrient Distribution Range (AMDR) recommended by the Dietary Guidelines
           for Americans (10-35%).

      The following variables will be analyzed:

        -  Interleukin (IL)-6.

        -  Gut microbiota diversity and composition, specifically taxa that have been associated
           with health benefits, obesity, and weight loss.

        -  Systemic inflammatory biomarkers (high-sensitivity C-reactive protein [hs-CRP], IL-8,
           IL-10 and tumor necrosis factor-α [TNF-α]);

        -  Metabolic blood markers [glucose, insulin, lipid panel (i.e. total cholesterol, LDL,
           HDL, and triglycerides), peptide tyrosine-tyrosine (PYY), glucagon-like peptide-1
           (GLP-1), ghrelin, adiponectin, leptin, free glycerol, free fatty acids, and thyroid
           stimulating hormone (TSH)];

        -  Resting energy expenditure;

        -  Body composition;

        -  Appetite sensations (hunger, satiety, fullness, and prospective food consumption);

        -  Soy polyphenols' metabolomics.

        -  Gene expression and genetic polymorphisms. At baseline and after 6 and 12 weeks,
           individuals will attend our Human Nutrition Research Unit where all assessments will
           take place. In order to assess participants' adherence and follow-up, dietary intake,
           body weight and appetite sensations will be assessed weekly during the 12-week
           intervention period. Additionally, participants will be contacted by phone weekly and
           reminded to maintain their journal/log. Dietary intake will be assessed by a 3-day
           dietary record (2 week days and 1 weekend day) at baseline, at mid-point and end of the
           study. Participants will also be asked to complete a 1-day dietary record on one
           weekday, each week of the study. The purpose of this regular assessment is to avoid
           daily fluctuations in eating patterns, also ensuring a personalized feedback for those
           experiencing weight fluctuations. Both of these assessments (i.e. 1-day and 3-day
           dietary records) will be conducted using the online Automated Self -Administered 24-hour
           Recall (ASA24) Canada. The ASA24 is a validated web-based program that uses the
           validated U.S. Department of Agriculture's Automated Multiple-Pass Method, and is
           modified to support the Canadian food supply.

      Participants will receive a digital scale and will be asked to weight themselves daily.
      Participants from the PMR group will also be asked to rate their appetite sensations on a
      100-mm VAS paper sheet. Appetite sensation should be completed in the morning (after waking
      up and while fasting) and 30 minutes after consuming the supplement snacks in order to assess
      hunger, satiety, fullness, and prospective food consumption.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Interleukin-6.
time frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
description: Changes in blood interleukin-6 will be assessed at baseline, middle and end of the 12-week dietary intervention period.
measure: Gut microbiota diversity and composition.
time frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
description: Changes in gut microbiome diversity and composition (specifically taxa that have been associated with health benefits, obesity and weight loss) will be assessed at baseline, middle and end of the 12-week dietary intervention period.
measure: High-sensitivity C-reactive protein.
time frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
description: Changes in blood high-sensitivity C-reactive protein will be assessed at baseline, middle and end of the 12-week dietary intervention period.
measure: Interleukin 8.
time frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
description: Changes in interleukin 8 will be assessed at baseline, middle and end of the 12-week dietary intervention period.
measure: Interleukin 10.
time frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
description: Changes in interleukin 10 will be assessed at baseline, middle and end of the 12-week dietary intervention period.
measure: Tumor necrosis factor-α.
time frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
description: Changes in tumor necrosis factor-α will be assessed at baseline, middle and end of the 12-week dietary intervention period.
measure: Adiponectin.
time frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
description: Changes in adiponectin will be assessed at baseline, middle and end of the 12-week dietary intervention period.
measure: Blood glucose.
time frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
description: Changes in blood glucose will be assessed at baseline, middle and end of the 12-week dietary intervention period.
measure: Insulin.
time frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
description: Changes in insulin will be assessed at baseline, middle and end of the 12-week dietary intervention period.
measure: Lipid panel.
time frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
description: Changes in lipid panel (i.e. total cholesterol, LDL, HDL and triglycerides) will be assessed at baseline, middle and end of the 12-week dietary intervention period.
measure: Peptide tyrosine-tyrosine.
time frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
description: Changes in peptide tyrosine-tyrosine will be assessed at baseline, middle and end of the 12-week dietary intervention period.
measure: Glucagon-like peptide 1.
time frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
description: Changes in glucagon-like peptide-1 will be assessed at baseline, middle and end of the 12-week dietary intervention period.
measure: Ghrelin.
time frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
description: Changes in ghrelin will be assessed at baseline, middle and end of the 12-week dietary intervention period.
measure: Leptin.
time frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
description: Changes in leptin will be assessed at baseline, middle and end of the 12-week dietary intervention period.
measure: Free glycerol.
time frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
description: Changes free glycerol will be assessed at baseline, middle and end of the 12-week dietary intervention period.
measure: Free fatty acids.
time frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
description: Changes in free fatty acids will be assessed at baseline, middle and end of the 12-week dietary intervention period.
measure: Thyroid stimulating hormone.
time frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
description: Changes in thyroid stimulating hormone will be assessed at baseline, middle and end of the 12-week dietary intervention period.
measure: Resting energy expenditure.
time frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
description: Changes in resting energy expenditure will be assessed at baseline, middle and end of the 12-week dietary intervention period using a whole body calorimetry unit.
measure: Body composition.
time frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
description: Changes in fat mass, lean soft tissue and bone mineral content will be assessed at baseline, middle and end of the 12-week dietary intervention period using dual-energy X-ray absorptiometry.
measure: Appetite sensations.
time frame: Once per week during the intervention period (12 weeks).
description: Changes in hunger, satiety, fullness, and prospective food consumption will be assessed weekly using a 100 mm visual analogue scale.
measure: Soy polyphenols' metabolomics.
time frame: At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).
description: Soy polyphenols' metabolomics will be assessed on participants assigned to the 12-week dietary intervention periodPowdered Meal Replacement group at baseline, middle and end of the 12-week dietary intervention period using blood and urine samples.
measure: Gene expression
time frame: At baseline (week 1) and end (week 12) of the intervention period (12 weeks).
description: Changes in gene expression will be assessed at baseline and at the end of the 12-week dietary intervention period
measure: Genetic polymorphisms
time frame: At baseline (week 1)
description: Genetic polymorphisms will be identified at baseline
arm group label: Control Group
arm group type: No Intervention
description: Those assigned to the Control group will be asked to maintain their usual dietary intake over 12 weeks. Participants' usual dietary intake is expected to reflect the North American dietary pattern (i.e. ~15% of total energy intake coming from protein, ~50% from carbohydrate and ~35% from fat).
arm group label: Powdered Meal Replacement Group
arm group type: Experimental
description: Those assigned to the Powdered Meal Replacement group will be asked to maintain their usual dietary intake and consume a powdered meal replacement composed of soy protein, honey and yogurt twice daily (in two snacks) over 12 weeks. The addition of the nutritional supplement to a North American Dietary Pattern (described on the CON group diet) will result in a diet composed of, approximately, 22% of protein, 48% of carbohydrate and 30% of fat of total energy intake. The amount of protein is considered higher than the North American dietary pattern (i.e. 15%); however, still within the Acceptable Macronutrient Distribution Range (AMDR) recommended by the Dietary Guidelines for Americans (10-35%).
intervention type: Dietary Supplement
intervention name: Soy protein, honey and yogurt.
description: Participants will be asked to maintain their usual dietary intake and consume a powdered meal replacement composed of soy protein, honey and yogurt twice daily (in two snacks) over 12 weeks. The addition of the nutritional supplement to a North American Dietary Pattern (described on the CON group diet) will result in a diet composed of, approximately, 22% of protein, 48% of carbohydrate and 30% of fat of total energy intake. The amount of protein is considered higher than the North American dietary pattern (i.e. 15%); however, still within the Acceptable Macronutrient Distribution Range (AMDR) recommended by the Dietary Guidelines for Americans (10-35%).
arm group label: Powdered Meal Replacement Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jens Walter, PhD
role: Principal Investigator
affiliation: University of Alberta
last name: Carla M Prado, PhD
role: Principal Investigator
affiliation: University of Alberta
last name: Arya Sharma, PhD
role: Principal Investigator
affiliation: University of Alberta
last name: Julia Montenegro, MSc
phone: (780) 492-7820
email: premium@ualberta.ca
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Sponsor
sharing ipd: No