<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/NCT03814473</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00000104</org_study_id>
    <nct_id>NCT03814473</nct_id>
  </id_info>
  <brief_title>Paleo Diet 8wk Feasibility in Overweight Adults</brief_title>
  <official_title>Eight Week ad Libitum Self-prepared Paleo Diet and Cardiometabolic Disease Risk Factors in Overweight Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chatham University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Houston</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Overweight, physically inactive but otherwise healthy adults habitually eating a traditional&#xD;
      Western diet will follow an ad libitum self-administered Paleo diet for 8-weeks. Blood and&#xD;
      body composition will be measured before and after the intervention period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Paleo diet is a dietary method that is gaining popularity among the general population&#xD;
      due to potential weight loss and disease prevention benefits. The feasibility of the Paleo&#xD;
      diet and the effectiveness of self-administration in improving cardiometabolic disease risk&#xD;
      factors remains uncertain. Examination od cardiometabolic disease risk factors in overweight,&#xD;
      physically inactive adults before and after 8-weeks of an ad libitum self-administered Paleo&#xD;
      dietary intervention. Methods: Overweight, physically inactive but otherwise healthy adults&#xD;
      habitually eating a traditional Western diet follow an ad libitum self-administered Paleo&#xD;
      diet for 8-weeks. Blood samples were analyzed for fasting cardiometabolic disease biomarkers.&#xD;
      Participants complete three-day dietary recalls prior to, and during weeks 4 and 8 of the&#xD;
      intervention to confirm Western diet consumption at pre-, track compliance, and to assess&#xD;
      dietary changes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 19, 2015</start_date>
  <completion_date type="Actual">April 14, 2015</completion_date>
  <primary_completion_date type="Actual">April 14, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum cytokines</measure>
    <time_frame>Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)</time_frame>
    <description>Serum measurement of interleukin (IL)-4 (pg/dL), IL-10 (pg/dL), interferon (INF)-gamma (pg/dL), tumor necrosis factor (TNF; pg/dL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum growth factor</measure>
    <time_frame>Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)</time_frame>
    <description>Serum measurement of brain derived neurotrophic factor (BDNF; ng/mL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum biomarkers of energy homeostasis</measure>
    <time_frame>Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)</time_frame>
    <description>Serum fibroblast growth factor (FGF)-21 (pg/mL) and adiponectin (pg/mL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum glucose metabolism biomarkers</measure>
    <time_frame>Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)</time_frame>
    <description>leptin (mg/dL), glucagon-like peptide (GLP)-1 (mg/dL), resistin (mg/dL), insulin (mg/dL), Gastric inhibitory polypeptide (GIP; mg/dL), glucagon (mg/dL), visfatin (mg/dL), ghrelin (mg/dL), plasminogen activator inhibitor (PAI)-1 (mg/dL), C-peptide (mg/dL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum adipokines</measure>
    <time_frame>Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)</time_frame>
    <description>Serum omentin (ng/mL) and nesfatin (ng/mL)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Waist and hip circumference</measure>
    <time_frame>Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)</time_frame>
    <description>Circumference of two midsection areas of the body (waist and hip) to estimate central adiposity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subcutaneous body fat</measure>
    <time_frame>Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)</time_frame>
    <description>Skin fold thickness (mm) of body fat</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary composition</measure>
    <time_frame>Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)</time_frame>
    <description>3-day food diary to approximate macronutrient composition (grams)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary energy intake</measure>
    <time_frame>Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)</time_frame>
    <description>3-day food diary to approximate total energy intake (kcal)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)</time_frame>
    <description>Measurement of blood pressure from the arm (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)</time_frame>
    <description>Measurement of participant's body weight (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body height</measure>
    <time_frame>pre-intervention (week zero)</time_frame>
    <description>Measurement of participant's height (m) to (along with body weight) calculate body mass index (kg/m^2)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>Dietary intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will follow an ad libitum self-administered Paleo diet for 8-weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diet</intervention_name>
    <description>Participants provided with a brochure providing a thorough description of the diet, ~8 example recipes for each meal (i.e. breakfast, lunch, dinner, and snacks) included as a sample menu, and guidance to assist in shopping and self-preparation of food for the prescribed diet and to improve adherence. Diet consisted of following the popular &quot;paleolithic&quot; diet</description>
    <arm_group_label>Dietary intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18-55 years&#xD;
&#xD;
          -  BMI &gt; 25 kg/m2&#xD;
&#xD;
          -  Currently consuming a typical Western diet (high carbohydrate, low fat diet), which&#xD;
             will be assessed using the 3-day dietary record (public domain)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known cardiovascular, metabolic (including type I or type II diabetes), or respiratory&#xD;
             disease&#xD;
&#xD;
          -  smoking and/or smokeless tobacco users&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andres Carrillo</last_name>
    <role>Study Director</role>
    <affiliation>Chatham University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chatham University</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Houston</investigator_affiliation>
    <investigator_full_name>Melissa M Markofski</investigator_full_name>
    <investigator_title>Asssitant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>non-identifiable study variables (i.e. serum biomarkers) may be deposited in sharing databases for open access publications</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/NCT03814473
org study id: STUDY00000104
nct id: NCT03814473
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Overweight, physically inactive but otherwise healthy adults habitually eating a traditional
      Western diet will follow an ad libitum self-administered Paleo diet for 8-weeks. Blood and
      body composition will be measured before and after the intervention period.
The Paleo diet is a dietary method that is gaining popularity among the general population
      due to potential weight loss and disease prevention benefits. The feasibility of the Paleo
      diet and the effectiveness of self-administration in improving cardiometabolic disease risk
      factors remains uncertain. Examination od cardiometabolic disease risk factors in overweight,
      physically inactive adults before and after 8-weeks of an ad libitum self-administered Paleo
      dietary intervention. Methods: Overweight, physically inactive but otherwise healthy adults
      habitually eating a traditional Western diet follow an ad libitum self-administered Paleo
      diet for 8-weeks. Blood samples were analyzed for fasting cardiometabolic disease biomarkers.
      Participants complete three-day dietary recalls prior to, and during weeks 4 and 8 of the
      intervention to confirm Western diet consumption at pre-, track compliance, and to assess
      dietary changes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Serum cytokines
time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
description: Serum measurement of interleukin (IL)-4 (pg/dL), IL-10 (pg/dL), interferon (INF)-gamma (pg/dL), tumor necrosis factor (TNF; pg/dL)
measure: Serum growth factor
time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
description: Serum measurement of brain derived neurotrophic factor (BDNF; ng/mL)
measure: Serum biomarkers of energy homeostasis
time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
description: Serum fibroblast growth factor (FGF)-21 (pg/mL) and adiponectin (pg/mL)
measure: Serum glucose metabolism biomarkers
time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
description: leptin (mg/dL), glucagon-like peptide (GLP)-1 (mg/dL), resistin (mg/dL), insulin (mg/dL), Gastric inhibitory polypeptide (GIP; mg/dL), glucagon (mg/dL), visfatin (mg/dL), ghrelin (mg/dL), plasminogen activator inhibitor (PAI)-1 (mg/dL), C-peptide (mg/dL)
measure: Serum adipokines
time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
description: Serum omentin (ng/mL) and nesfatin (ng/mL)
measure: Waist and hip circumference
time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
description: Circumference of two midsection areas of the body (waist and hip) to estimate central adiposity
measure: Subcutaneous body fat
time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
description: Skin fold thickness (mm) of body fat
measure: Dietary composition
time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
description: 3-day food diary to approximate macronutrient composition (grams)
measure: Dietary energy intake
time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
description: 3-day food diary to approximate total energy intake (kcal)
measure: Blood pressure
time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
description: Measurement of blood pressure from the arm (mmHg)
measure: Body weight
time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
description: Measurement of participant's body weight (kg)
measure: Body height
time frame: pre-intervention (week zero)
description: Measurement of participant's height (m) to (along with body weight) calculate body mass index (kg/m^2)
arm group label: Dietary intervention
arm group type: Experimental
description: All participants will follow an ad libitum self-administered Paleo diet for 8-weeks
intervention type: Other
intervention name: Diet
description: Participants provided with a brochure providing a thorough description of the diet, ~8 example recipes for each meal (i.e. breakfast, lunch, dinner, and snacks) included as a sample menu, and guidance to assist in shopping and self-preparation of food for the prescribed diet and to improve adherence. Diet consisted of following the popular "paleolithic" diet
arm group label: Dietary intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andres Carrillo
role: Study Director
affiliation: Chatham University
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Houston
investigator full name: Melissa M Markofski
investigator title: Asssitant Professor
mesh term: Overweight
sharing ipd: Undecided
ipd description: non-identifiable study variables (i.e. serum biomarkers) may be deposited in sharing databases for open access publications