<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/NCT03003897</url>
  </required_header>
  <id_info>
    <org_study_id>Soluble Fiber Review</org_study_id>
    <nct_id>NCT03003897</nct_id>
  </id_info>
  <brief_title>Meta-analysis of Soluble Fiber Consumption on Body Weight, Glycemia, and Insulinemia in Overweight and Obese Adults.</brief_title>
  <official_title>Effects of Soluble Fiber Consumption on Body Weight, Glycemia, and Insulinemia in Adults With Overweight and Obesity: a Systematic Review and Meta-analysis of Randomized Controlled Trials.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Illinois at Urbana-Champaign</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Illinois at Urbana-Champaign</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dietary fiber intake is protective against overweight and obesity; however, a significant&#xD;
      fiber gap exists between consumption and recommended intake values. Soluble fiber&#xD;
      beneficially impacts metabolism, and supplementation may be a feasible approach to improve&#xD;
      body composition and glycemia in overweight and obese individuals. The investigators will&#xD;
      evaluate results of randomized controlled trials (RCTs) of soluble fiber supplementation&#xD;
      among overweight and obese adults for outcomes related to weight management (e.g. body mass&#xD;
      index [BMI], body weight, body fat percentage, waist circumference) and glucose and insulin&#xD;
      homeostasis (e.g. fasting glucose, homeostasis model assessment of insulin resistance&#xD;
      [HOMA-IR], fasting insulin) through systematic review and meta-analysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Body mass index (kg/m2)</measure>
    <time_frame>≥ 1 week</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Body weight (kg)</measure>
    <time_frame>≥ 1 week</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Body fat (% fat mass)</measure>
    <time_frame>≥ 1 week</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Waist circumference (cm)</measure>
    <time_frame>≥ 1 week</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Fasting glucose (mmol/l)</measure>
    <time_frame>≥ 1 week</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Fasting insulin (pmol/l)</measure>
    <time_frame>≥ 1 week</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)</measure>
    <time_frame>≥ 1 week</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">609</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Soluble Fiber Treatment</arm_group_label>
    <description>Participants receiving soluble fiber.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Treatment</arm_group_label>
    <description>Participants receiving placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Soluble Fiber</intervention_name>
    <description>Participants receiving soluble fiber.</description>
    <arm_group_label>Soluble Fiber Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants receiving placebo.</description>
    <arm_group_label>Placebo Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults ≥ 18 years of age with overweight and obesity but without physician diagnosed&#xD;
        chronic disease at screening.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Peer-reviewed randomized controlled trials (RCTs) will be included in the systematic review&#xD;
        and meta-analysis if they involve participants who are:&#xD;
&#xD;
          1. Overweight or obese (BMI ≥ 25.0 kg/m2 for U.S. populations and ≥ 23.0 kg/m2 for Asian&#xD;
             populations and/or waist circumference ≥ 40 inches (94 cm) in men or ≥ 35 inches (80&#xD;
             cm) in women and/or waist-to-hip ratio ≥ 0.90 in men or ≥ 0.85 in women).&#xD;
&#xD;
          2. Weight stable and not actively trying to lose weight at screening.&#xD;
&#xD;
          3. Without physician-diagnosed chronic conditions at screening (e.g., dyslipidemia,&#xD;
             hypertension, type 2 diabetes, and cardiovascular disease).&#xD;
&#xD;
          4. Included studies will be soluble fiber supplementation interventions that are&#xD;
             controlled feeding studies or conducted among free-living subjects that provide data&#xD;
             for outcomes of interest.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Studies will be excluded from the systematic review and meta-analysis if they meet any of&#xD;
        the following criteria:&#xD;
&#xD;
          1. Studies conducted in animals.&#xD;
&#xD;
          2. Mechanistic research.&#xD;
&#xD;
          3. Human trials involving pregnant women, breastfeeding women, or children.&#xD;
&#xD;
          4. Conference proceedings.&#xD;
&#xD;
          5. Articles not published in English.&#xD;
&#xD;
          6. Studies less than 1 week in duration.&#xD;
&#xD;
          7. Studies that pool outcome measure data for healthy weight and overweight and obese&#xD;
             individuals.&#xD;
&#xD;
          8. Studies involving whole food treatments or high fiber profile diets.&#xD;
&#xD;
          9. Weight loss interventions involving other tactics, such as counseling or energy&#xD;
             restriction.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Illinois, Urbana-Champaign</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Thompson SV, Hannon BA, An R, Holscher HD. Effects of isolated soluble fiber supplementation on body weight, glycemia, and insulinemia in adults with overweight and obesity: a systematic review and meta-analysis of randomized controlled trials. Am J Clin Nutr. 2017 Dec;106(6):1514-1528. doi: 10.3945/ajcn.117.163246. Epub 2017 Nov 1.</citation>
    <PMID>29092878</PMID>
  </results_reference>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>October 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>July 6, 2018</last_update_submitted>
  <last_update_submitted_qc>July 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dietary Fiber</keyword>
  <keyword>Soluble Fiber</keyword>
  <keyword>Body Mass Index</keyword>
  <keyword>Body Weight</keyword>
  <keyword>Blood Glucose</keyword>
  <keyword>Insulin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Body Weight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data has been previously published in the randomized controlled trials we intend to analyze.</ipd_description>
  </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/NCT03003897
org study id: Soluble Fiber Review
nct id: NCT03003897
lead sponsor: 
has dmc: No
Dietary fiber intake is protective against overweight and obesity; however, a significant
      fiber gap exists between consumption and recommended intake values. Soluble fiber
      beneficially impacts metabolism, and supplementation may be a feasible approach to improve
      body composition and glycemia in overweight and obese individuals. The investigators will
      evaluate results of randomized controlled trials (RCTs) of soluble fiber supplementation
      among overweight and obese adults for outcomes related to weight management (e.g. body mass
      index [BMI], body weight, body fat percentage, waist circumference) and glucose and insulin
      homeostasis (e.g. fasting glucose, homeostasis model assessment of insulin resistance
      [HOMA-IR], fasting insulin) through systematic review and meta-analysis.
observational model: Cohort
time perspective: Prospective
measure: Body mass index (kg/m2)
time frame: ≥ 1 week
measure: Body weight (kg)
time frame: ≥ 1 week
measure: Body fat (% fat mass)
time frame: ≥ 1 week
measure: Waist circumference (cm)
time frame: ≥ 1 week
measure: Fasting glucose (mmol/l)
time frame: ≥ 1 week
measure: Fasting insulin (pmol/l)
time frame: ≥ 1 week
measure: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
time frame: ≥ 1 week
arm group label: Soluble Fiber Treatment
description: Participants receiving soluble fiber.
arm group label: Placebo Treatment
description: Participants receiving placebo.
intervention type: Other
intervention name: Soluble Fiber
description: Participants receiving soluble fiber.
arm group label: Soluble Fiber Treatment
intervention type: Other
intervention name: Placebo
description: Participants receiving placebo.
arm group label: Placebo Treatment
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
citation: Thompson SV, Hannon BA, An R, Holscher HD. Effects of isolated soluble fiber supplementation on body weight, glycemia, and insulinemia in adults with overweight and obesity: a systematic review and meta-analysis of randomized controlled trials. Am J Clin Nutr. 2017 Dec;106(6):1514-1528. doi: 10.3945/ajcn.117.163246. Epub 2017 Nov 1.
PMID: 29092878
responsible party type: Sponsor
mesh term: Obesity
mesh term: Overweight
mesh term: Body Weight
sharing ipd: No
ipd description: Individual participant data has been previously published in the randomized controlled trials we intend to analyze.