<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/NCT01686204</url>
  </required_header>
  <id_info>
    <org_study_id>2014-0669</org_study_id>
    <nct_id>NCT01686204</nct_id>
  </id_info>
  <brief_title>Reduction of Obesity-Associated Intestinal Inflammation by Low-Fat Dairy Yogurt</brief_title>
  <official_title>Reduction of Obesity-Associated Intestinal Inflammation by Low-Fat Dairy Yogurt</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dairy Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <brief_summary>
    <textblock>
      The main objective of this work is to conduct a clinical trial in obese and non-obese&#xD;
      individuals testing the ability of low-fat dairy yogurt to improve gastrointestinal health&#xD;
      and reduce chronic inflammation. Our central hypothesis is that short and long-term&#xD;
      consumption of low-fat dairy yogurt will reduce inflammation to a greater extent in obese&#xD;
      individuals by improving intestinal barrier function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">March 31, 2017</completion_date>
  <primary_completion_date type="Actual">September 30, 2016</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>Plasma soluble cluster of differentiation 14 (sCD14)</measure>
    <time_frame>0, 3, 6, and 9 wk</time_frame>
    <description>Fasting plasma sCD14 (change from baseline)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fasting plasma interleukin-6 (IL-6)</measure>
    <time_frame>0, 3, 6, 9 wk</time_frame>
    <description>Fasting plasma IL-6 (change from baseline)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial sCD14</measure>
    <time_frame>0 and 9 wk</time_frame>
    <description>Postprandial plasma sCD14 following a high-fat, high-calorie challenge meal (area under curve)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial interleukin-6 (IL-6)</measure>
    <time_frame>0 and 9 wk</time_frame>
    <description>Postprandial plasma IL-6 following a high-fat, high-calorie challenge meal (area under curve)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Fasting lipopolysaccharide binding protein (LBP)</measure>
    <time_frame>0 and 9 wk</time_frame>
    <description>Determined by immunoassay</description>
  </other_outcome>
  <other_outcome>
    <measure>Fasting plasma endotoxin (LPS, lipopolysaccharide)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Determined by limulus amebocyte lysate assay</description>
  </other_outcome>
  <other_outcome>
    <measure>Fasting plasma core antibodies to endotoxin</measure>
    <time_frame>0 and 9 wk</time_frame>
    <description>Immunoglobulin M Endotoxin-core antibody (IgM EndoCAb)</description>
  </other_outcome>
  <other_outcome>
    <measure>Fasting plasma anandamide (AEA)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Determined by LC-MS</description>
  </other_outcome>
  <other_outcome>
    <measure>Fasting plasma 2-arachidonoylglycerol (2-AG)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Determined by LC-MS</description>
  </other_outcome>
  <other_outcome>
    <measure>Fasting plasma IL-10</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Determined by immunoassay</description>
  </other_outcome>
  <other_outcome>
    <measure>Fasting plasma high-sensitivity C-reactive protein (hsCRP)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Determined in fasting plasma</description>
  </other_outcome>
  <other_outcome>
    <measure>Fasting plasma Tumor Necrosis Factor-alpha (TNF-α)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Determined in fasting plasma</description>
  </other_outcome>
  <other_outcome>
    <measure>Fasting plasma Soluble TNF-Receptor II (sTNF-RII)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Determined in fasting plasma</description>
  </other_outcome>
  <other_outcome>
    <measure>TNF-alpha/sTNF-RII ratio</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Determined in fasting plasma</description>
  </other_outcome>
  <other_outcome>
    <measure>Fasting plasma glucose</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Determined in fasting plasma</description>
  </other_outcome>
  <other_outcome>
    <measure>Fasting plasma triglycerides</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Determined in fasting plasma</description>
  </other_outcome>
  <other_outcome>
    <measure>Fasting plasma insulin</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Determined in fasting plasma</description>
  </other_outcome>
  <other_outcome>
    <measure>Fasting plasma soluble cluster of differentiation 14 (sCD14)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Determined in fasting plasma</description>
  </other_outcome>
  <other_outcome>
    <measure>Body weight</measure>
    <time_frame>0, 3, 6, 9 wk</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Body mass index</measure>
    <time_frame>0, 3, 6, 9 wk</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Waist circumference</measure>
    <time_frame>0, 3, 6, 9 wk</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>0, 3, 6, 9 wk</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Diastolic blood pressure</measure>
    <time_frame>0, 3, 6, 9 wk</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Fasting RPLP0, encoding ribosomal protein large P0</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)</description>
  </other_outcome>
  <other_outcome>
    <measure>TLR4, encoding Toll-like receptor 4</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)</description>
  </other_outcome>
  <other_outcome>
    <measure>RELA, encoding p65 subunit of nuclear factor kappa B</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)</description>
  </other_outcome>
  <other_outcome>
    <measure>NFKBIA, encoding nuclear factor kappa B inhibitor alpha</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)</description>
  </other_outcome>
  <other_outcome>
    <measure>PTGS2, encoding cyclooxygenase-2 (COX-2)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)</description>
  </other_outcome>
  <other_outcome>
    <measure>NCF1,encoding the p47 subunit of nicotinamide adenine dinucleotide phosphate-oxidase, (NADPH oxidase)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)</description>
  </other_outcome>
  <other_outcome>
    <measure>TNF, encoding tumor necrosis factors (TNF)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)</description>
  </other_outcome>
  <other_outcome>
    <measure>IFNG, encoding interferon-γ</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)</description>
  </other_outcome>
  <other_outcome>
    <measure>TGFB1, encoding transforming growth factor beta 1 (TGFβ1)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)</description>
  </other_outcome>
  <other_outcome>
    <measure>Postprandial plasma glucose</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Postprandial plasma glucose following a high-fat, high-calorie challenge meal (area under curve)</description>
  </other_outcome>
  <other_outcome>
    <measure>Postprandial plasma triglycerides</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Postprandial plasma triglycerides following a high-fat, high-calorie challenge meal (area under curve)</description>
  </other_outcome>
  <other_outcome>
    <measure>Postprandial lipopolysaccharide binding protein (LBP)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Postprandial plasma LBP following a high-fat, high-calorie challenge meal (area under curve)</description>
  </other_outcome>
  <other_outcome>
    <measure>Postprandial lipopolysaccharide (LPS)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Postprandial plasma LPS following a high-fat, high-calorie challenge meal determined by limulus amebocyte lysate assay (area under curve)</description>
  </other_outcome>
  <other_outcome>
    <measure>Postprandial lipopolysaccharide binding protein (LBP)/soluble cluster of differentiation 14 (sCD14) ratio</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Postprandial LBP/sCD14 ratio following a high-fat, high-calorie challenge meal (area under curve)</description>
  </other_outcome>
  <other_outcome>
    <measure>Postprandial plasma insulin</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Postprandial plasma insulin following a high-fat, high-calorie challenge meal (area under curve)</description>
  </other_outcome>
  <other_outcome>
    <measure>Energy intake (kcal)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Self-reported food intake determined by dietary records</description>
  </other_outcome>
  <other_outcome>
    <measure>Total fat (g)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Self-reported nutrient intake determined by dietary records</description>
  </other_outcome>
  <other_outcome>
    <measure>Carbohydrate (g)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Self-reported nutrient intake determined by dietary records</description>
  </other_outcome>
  <other_outcome>
    <measure>Total protein (g)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Self-reported nutrient intake determined by dietary records</description>
  </other_outcome>
  <other_outcome>
    <measure>Total fat (%)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Self-reported nutrient intake determined by dietary records</description>
  </other_outcome>
  <other_outcome>
    <measure>Carbohydrate (%)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Self-reported nutrient intake determined by dietary records</description>
  </other_outcome>
  <other_outcome>
    <measure>Total protein (%)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Self-reported nutrient intake determined by dietary records</description>
  </other_outcome>
  <other_outcome>
    <measure>Cholestrol (mg)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Self-reported nutrient intake determined by dietary records</description>
  </other_outcome>
  <other_outcome>
    <measure>Saturated fatty acids (g)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Self-reported nutrient intake determined by dietary records</description>
  </other_outcome>
  <other_outcome>
    <measure>Vitamin D (μg)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Self-reported nutrient intake determined by dietary records</description>
  </other_outcome>
  <other_outcome>
    <measure>Calcium (mg)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Self-reported nutrient intake determined by dietary records</description>
  </other_outcome>
  <other_outcome>
    <measure>Sodium (mg)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Self-reported nutrient intake determined by dietary records</description>
  </other_outcome>
  <other_outcome>
    <measure>Potassium (mg)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Self-reported nutrient intake determined by dietary records</description>
  </other_outcome>
  <other_outcome>
    <measure>Total sugars (g)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Self-reported nutrient intake determined by dietary records</description>
  </other_outcome>
  <other_outcome>
    <measure>Added sugars (g)</measure>
    <time_frame>0, 9 wk</time_frame>
    <description>Self-reported nutrient intake determined by dietary records</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Intestinal Barrier Function</condition>
  <condition>Chronic Inflammation</condition>
  <arm_group>
    <arm_group_label>Non-obese individuals</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Daily consumption of 12 oz lowfat yogurt or soy pudding for 9 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obese individuals</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Consumption of 12 oz of soy pudding or low fat dairy yogurt daily for 9 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low fat dairy yogurt</intervention_name>
    <description>Consumption of 12 oz of low fat dairy yogurt daily for 9 weeks</description>
    <arm_group_label>Non-obese individuals</arm_group_label>
    <arm_group_label>Obese individuals</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Soy pudding</intervention_name>
    <description>Consumption of 12 oz of low fat soy pudding daily for 9 weeks.</description>
    <arm_group_label>Non-obese individuals</arm_group_label>
    <arm_group_label>Obese individuals</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  premenopausal women&#xD;
&#xD;
          -  BMI from 18.5-27 and 30-40 kg/m2&#xD;
&#xD;
          -  resting blood pressure &lt;140/90 mmHg&#xD;
&#xD;
          -  not taking medication to control hypertension&#xD;
&#xD;
          -  stable body weight for the previous 2 months&#xD;
&#xD;
          -  willing to maintain a normal exercise level and avoid exercise 24 h prior to blood&#xD;
             sampling&#xD;
&#xD;
          -  willing to avoid yogurt and probiotic-containing foods or consume 2 servings of yogurt&#xD;
             for the duration of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous diagnoses of cardiovascular disease (CVD), diabetes, or arthritis (except for&#xD;
             osteo-arthritis)&#xD;
&#xD;
          -  currently being treated for cancer (i.e., chemotherapy, radiation therapy)&#xD;
&#xD;
          -  prescribed estrogen replacement therapy&#xD;
&#xD;
          -  practicing weight-loss, vegetarian, kosher, or vegan diets&#xD;
&#xD;
          -  currently taking dietary supplements&#xD;
&#xD;
          -  exceed alcohol consumption more than moderate drinking (1 drink/day or a total of&#xD;
             7/week)&#xD;
&#xD;
          -  actively using antibiotics&#xD;
&#xD;
          -  taking anti-inflammatory drugs&#xD;
&#xD;
          -  have allergies to soy, egg or milk&#xD;
&#xD;
          -  perimenopausal or menopausal symptoms&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bradley W Bolling, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Food Science, Babcock Hall</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2012</study_first_posted>
  <last_update_submitted>September 29, 2017</last_update_submitted>
  <last_update_submitted_qc>September 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Yogurt</keyword>
  <keyword>Intestine</keyword>
  <keyword>Inflammation</keyword>
  <keyword>Obese</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <!-- 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/NCT01686204
org study id: 2014-0669
nct id: NCT01686204
lead sponsor: 
collaborator: 
The main objective of this work is to conduct a clinical trial in obese and non-obese
      individuals testing the ability of low-fat dairy yogurt to improve gastrointestinal health
      and reduce chronic inflammation. Our central hypothesis is that short and long-term
      consumption of low-fat dairy yogurt will reduce inflammation to a greater extent in obese
      individuals by improving intestinal barrier function.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Plasma soluble cluster of differentiation 14 (sCD14)
time frame: 0, 3, 6, and 9 wk
description: Fasting plasma sCD14 (change from baseline)
measure: Fasting plasma interleukin-6 (IL-6)
time frame: 0, 3, 6, 9 wk
description: Fasting plasma IL-6 (change from baseline)
measure: Postprandial sCD14
time frame: 0 and 9 wk
description: Postprandial plasma sCD14 following a high-fat, high-calorie challenge meal (area under curve)
measure: Postprandial interleukin-6 (IL-6)
time frame: 0 and 9 wk
description: Postprandial plasma IL-6 following a high-fat, high-calorie challenge meal (area under curve)
measure: Fasting lipopolysaccharide binding protein (LBP)
time frame: 0 and 9 wk
description: Determined by immunoassay
measure: Fasting plasma endotoxin (LPS, lipopolysaccharide)
time frame: 0, 9 wk
description: Determined by limulus amebocyte lysate assay
measure: Fasting plasma core antibodies to endotoxin
time frame: 0 and 9 wk
description: Immunoglobulin M Endotoxin-core antibody (IgM EndoCAb)
measure: Fasting plasma anandamide (AEA)
time frame: 0, 9 wk
description: Determined by LC-MS
measure: Fasting plasma 2-arachidonoylglycerol (2-AG)
time frame: 0, 9 wk
description: Determined by LC-MS
measure: Fasting plasma IL-10
time frame: 0, 9 wk
description: Determined by immunoassay
measure: Fasting plasma high-sensitivity C-reactive protein (hsCRP)
time frame: 0, 9 wk
description: Determined in fasting plasma
measure: Fasting plasma Tumor Necrosis Factor-alpha (TNF-α)
time frame: 0, 9 wk
description: Determined in fasting plasma
measure: Fasting plasma Soluble TNF-Receptor II (sTNF-RII)
time frame: 0, 9 wk
description: Determined in fasting plasma
measure: TNF-alpha/sTNF-RII ratio
time frame: 0, 9 wk
description: Determined in fasting plasma
measure: Fasting plasma glucose
time frame: 0, 9 wk
description: Determined in fasting plasma
measure: Fasting plasma triglycerides
time frame: 0, 9 wk
description: Determined in fasting plasma
measure: Fasting plasma insulin
time frame: 0, 9 wk
description: Determined in fasting plasma
measure: Fasting plasma soluble cluster of differentiation 14 (sCD14)
time frame: 0, 9 wk
description: Determined in fasting plasma
measure: Body weight
time frame: 0, 3, 6, 9 wk
measure: Body mass index
time frame: 0, 3, 6, 9 wk
measure: Waist circumference
time frame: 0, 3, 6, 9 wk
measure: Systolic blood pressure
time frame: 0, 3, 6, 9 wk
measure: Diastolic blood pressure
time frame: 0, 3, 6, 9 wk
measure: Fasting RPLP0, encoding ribosomal protein large P0
time frame: 0, 9 wk
description: mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)
measure: TLR4, encoding Toll-like receptor 4
time frame: 0, 9 wk
description: mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)
measure: RELA, encoding p65 subunit of nuclear factor kappa B
time frame: 0, 9 wk
description: mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)
measure: NFKBIA, encoding nuclear factor kappa B inhibitor alpha
time frame: 0, 9 wk
description: mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)
measure: PTGS2, encoding cyclooxygenase-2 (COX-2)
time frame: 0, 9 wk
description: mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)
measure: NCF1,encoding the p47 subunit of nicotinamide adenine dinucleotide phosphate-oxidase, (NADPH oxidase)
time frame: 0, 9 wk
description: mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)
measure: TNF, encoding tumor necrosis factors (TNF)
time frame: 0, 9 wk
description: mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)
measure: IFNG, encoding interferon-γ
time frame: 0, 9 wk
description: mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)
measure: TGFB1, encoding transforming growth factor beta 1 (TGFβ1)
time frame: 0, 9 wk
description: mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)
measure: Postprandial plasma glucose
time frame: 0, 9 wk
description: Postprandial plasma glucose following a high-fat, high-calorie challenge meal (area under curve)
measure: Postprandial plasma triglycerides
time frame: 0, 9 wk
description: Postprandial plasma triglycerides following a high-fat, high-calorie challenge meal (area under curve)
measure: Postprandial lipopolysaccharide binding protein (LBP)
time frame: 0, 9 wk
description: Postprandial plasma LBP following a high-fat, high-calorie challenge meal (area under curve)
measure: Postprandial lipopolysaccharide (LPS)
time frame: 0, 9 wk
description: Postprandial plasma LPS following a high-fat, high-calorie challenge meal determined by limulus amebocyte lysate assay (area under curve)
measure: Postprandial lipopolysaccharide binding protein (LBP)/soluble cluster of differentiation 14 (sCD14) ratio
time frame: 0, 9 wk
description: Postprandial LBP/sCD14 ratio following a high-fat, high-calorie challenge meal (area under curve)
measure: Postprandial plasma insulin
time frame: 0, 9 wk
description: Postprandial plasma insulin following a high-fat, high-calorie challenge meal (area under curve)
measure: Energy intake (kcal)
time frame: 0, 9 wk
description: Self-reported food intake determined by dietary records
measure: Total fat (g)
time frame: 0, 9 wk
description: Self-reported nutrient intake determined by dietary records
measure: Carbohydrate (g)
time frame: 0, 9 wk
description: Self-reported nutrient intake determined by dietary records
measure: Total protein (g)
time frame: 0, 9 wk
description: Self-reported nutrient intake determined by dietary records
measure: Total fat (%)
time frame: 0, 9 wk
description: Self-reported nutrient intake determined by dietary records
measure: Carbohydrate (%)
time frame: 0, 9 wk
description: Self-reported nutrient intake determined by dietary records
measure: Total protein (%)
time frame: 0, 9 wk
description: Self-reported nutrient intake determined by dietary records
measure: Cholestrol (mg)
time frame: 0, 9 wk
description: Self-reported nutrient intake determined by dietary records
measure: Saturated fatty acids (g)
time frame: 0, 9 wk
description: Self-reported nutrient intake determined by dietary records
measure: Vitamin D (μg)
time frame: 0, 9 wk
description: Self-reported nutrient intake determined by dietary records
measure: Calcium (mg)
time frame: 0, 9 wk
description: Self-reported nutrient intake determined by dietary records
measure: Sodium (mg)
time frame: 0, 9 wk
description: Self-reported nutrient intake determined by dietary records
measure: Potassium (mg)
time frame: 0, 9 wk
description: Self-reported nutrient intake determined by dietary records
measure: Total sugars (g)
time frame: 0, 9 wk
description: Self-reported nutrient intake determined by dietary records
measure: Added sugars (g)
time frame: 0, 9 wk
description: Self-reported nutrient intake determined by dietary records
arm group label: Non-obese individuals
arm group type: Active Comparator
description: Daily consumption of 12 oz lowfat yogurt or soy pudding for 9 weeks.
arm group label: Obese individuals
arm group type: Experimental
description: Consumption of 12 oz of soy pudding or low fat dairy yogurt daily for 9 weeks.
intervention type: Other
intervention name: Low fat dairy yogurt
description: Consumption of 12 oz of low fat dairy yogurt daily for 9 weeks
arm group label: Non-obese individuals
arm group label: Obese individuals
intervention type: Other
intervention name: Soy pudding
description: Consumption of 12 oz of low fat soy pudding daily for 9 weeks.
arm group label: Non-obese individuals
arm group label: Obese individuals
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bradley W Bolling, PhD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
country: United States
responsible party type: Sponsor
mesh term: Inflammation