Back to resultsReduction of Obesity-Associated Intestinal Inflammation by Low-Fat Dairy Yogurt
Primary Purpose
Intestinal Barrier Function, Chronic Inflammation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low fat dairy yogurt
Soy pudding
Sponsored by
About this trial
This is an interventional basic science trial for Intestinal Barrier Function focused on measuring Yogurt, Intestine, Inflammation, Obese
Eligibility Criteria
Inclusion Criteria:
- premenopausal women
- BMI from 18.5-27 and 30-40 kg/m2
- resting blood pressure <140/90 mmHg
- not taking medication to control hypertension
- stable body weight for the previous 2 months
- willing to maintain a normal exercise level and avoid exercise 24 h prior to blood sampling
- willing to avoid yogurt and probiotic-containing foods or consume 2 servings of yogurt for the duration of the study
Exclusion Criteria:
- previous diagnoses of cardiovascular disease (CVD), diabetes, or arthritis (except for osteo-arthritis)
- currently being treated for cancer (i.e., chemotherapy, radiation therapy)
- prescribed estrogen replacement therapy
- practicing weight-loss, vegetarian, kosher, or vegan diets
- currently taking dietary supplements
- exceed alcohol consumption more than moderate drinking (1 drink/day or a total of 7/week)
- actively using antibiotics
- taking anti-inflammatory drugs
- have allergies to soy, egg or milk
- perimenopausal or menopausal symptoms
Sites / Locations
- Department of Food Science, Babcock Hall
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Non-obese individuals
Obese individuals
Arm Description
Daily consumption of 12 oz lowfat yogurt or soy pudding for 9 weeks.
Consumption of 12 oz of soy pudding or low fat dairy yogurt daily for 9 weeks.
Outcomes
Primary Outcome Measures
Plasma soluble cluster of differentiation 14 (sCD14)
Fasting plasma sCD14 (change from baseline)
Secondary Outcome Measures
Fasting plasma interleukin-6 (IL-6)
Fasting plasma IL-6 (change from baseline)
Postprandial sCD14
Postprandial plasma sCD14 following a high-fat, high-calorie challenge meal (area under curve)
Postprandial interleukin-6 (IL-6)
Postprandial plasma IL-6 following a high-fat, high-calorie challenge meal (area under curve)
Full Information
NCT ID
NCT01686204
First Posted
September 12, 2012
Last Updated
September 29, 2017
Sponsor
University of Wisconsin, Madison
Collaborators
Dairy Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01686204
Brief Title
Reduction of Obesity-Associated Intestinal Inflammation by Low-Fat Dairy Yogurt
Official Title
Reduction of Obesity-Associated Intestinal Inflammation by Low-Fat Dairy Yogurt
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 30, 2016 (Actual)
Study Completion Date
March 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Dairy Research Institute
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Barrier Function, Chronic Inflammation
Keywords
Yogurt, Intestine, Inflammation, Obese
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-obese individuals
Arm Type
Active Comparator
Arm Description
Daily consumption of 12 oz lowfat yogurt or soy pudding for 9 weeks.
Arm Title
Obese individuals
Arm Type
Experimental
Arm Description
Consumption of 12 oz of soy pudding or low fat dairy yogurt daily for 9 weeks.
Intervention Type
Other
Intervention Name(s)
Low fat dairy yogurt
Intervention Description
Consumption of 12 oz of low fat dairy yogurt daily for 9 weeks
Intervention Type
Other
Intervention Name(s)
Soy pudding
Intervention Description
Consumption of 12 oz of low fat soy pudding daily for 9 weeks.
Primary Outcome Measure Information:
Title
Plasma soluble cluster of differentiation 14 (sCD14)
Description
Fasting plasma sCD14 (change from baseline)
Time Frame
0, 3, 6, and 9 wk
Secondary Outcome Measure Information:
Title
Fasting plasma interleukin-6 (IL-6)
Description
Fasting plasma IL-6 (change from baseline)
Time Frame
0, 3, 6, 9 wk
Title
Postprandial sCD14
Description
Postprandial plasma sCD14 following a high-fat, high-calorie challenge meal (area under curve)
Time Frame
0 and 9 wk
Title
Postprandial interleukin-6 (IL-6)
Description
Postprandial plasma IL-6 following a high-fat, high-calorie challenge meal (area under curve)
Time Frame
0 and 9 wk
Other Pre-specified Outcome Measures:
Title
Fasting lipopolysaccharide binding protein (LBP)
Description
Determined by immunoassay
Time Frame
0 and 9 wk
Title
Fasting plasma endotoxin (LPS, lipopolysaccharide)
Description
Determined by limulus amebocyte lysate assay
Time Frame
0, 9 wk
Title
Fasting plasma core antibodies to endotoxin
Description
Immunoglobulin M Endotoxin-core antibody (IgM EndoCAb)
Time Frame
0 and 9 wk
Title
Fasting plasma anandamide (AEA)
Description
Determined by LC-MS
Time Frame
0, 9 wk
Title
Fasting plasma 2-arachidonoylglycerol (2-AG)
Description
Determined by LC-MS
Time Frame
0, 9 wk
Title
Fasting plasma IL-10
Description
Determined by immunoassay
Time Frame
0, 9 wk
Title
Fasting plasma high-sensitivity C-reactive protein (hsCRP)
Description
Determined in fasting plasma
Time Frame
0, 9 wk
Title
Fasting plasma Tumor Necrosis Factor-alpha (TNF-α)
Description
Determined in fasting plasma
Time Frame
0, 9 wk
Title
Fasting plasma Soluble TNF-Receptor II (sTNF-RII)
Description
Determined in fasting plasma
Time Frame
0, 9 wk
Title
TNF-alpha/sTNF-RII ratio
Description
Determined in fasting plasma
Time Frame
0, 9 wk
Title
Fasting plasma glucose
Description
Determined in fasting plasma
Time Frame
0, 9 wk
Title
Fasting plasma triglycerides
Description
Determined in fasting plasma
Time Frame
0, 9 wk
Title
Fasting plasma insulin
Description
Determined in fasting plasma
Time Frame
0, 9 wk
Title
Fasting plasma soluble cluster of differentiation 14 (sCD14)
Description
Determined in fasting plasma
Time Frame
0, 9 wk
Title
Body weight
Time Frame
0, 3, 6, 9 wk
Title
Body mass index
Time Frame
0, 3, 6, 9 wk
Title
Waist circumference
Time Frame
0, 3, 6, 9 wk
Title
Systolic blood pressure
Time Frame
0, 3, 6, 9 wk
Title
Diastolic blood pressure
Time Frame
0, 3, 6, 9 wk
Title
Fasting RPLP0, encoding ribosomal protein large P0
Description
mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)
Time Frame
0, 9 wk
Title
TLR4, encoding Toll-like receptor 4
Description
mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)
Time Frame
0, 9 wk
Title
RELA, encoding p65 subunit of nuclear factor kappa B
Description
mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)
Time Frame
0, 9 wk
Title
NFKBIA, encoding nuclear factor kappa B inhibitor alpha
Description
mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)
Time Frame
0, 9 wk
Title
PTGS2, encoding cyclooxygenase-2 (COX-2)
Description
mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)
Time Frame
0, 9 wk
Title
NCF1,encoding the p47 subunit of nicotinamide adenine dinucleotide phosphate-oxidase, (NADPH oxidase)
Description
mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)
Time Frame
0, 9 wk
Title
TNF, encoding tumor necrosis factors (TNF)
Description
mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)
Time Frame
0, 9 wk
Title
IFNG, encoding interferon-γ
Description
mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)
Time Frame
0, 9 wk
Title
TGFB1, encoding transforming growth factor beta 1 (TGFβ1)
Description
mRNA expression of peripheral blood mononuclear cell normalized to encoding 18s rRNA (RNA18S5)
Time Frame
0, 9 wk
Title
Postprandial plasma glucose
Description
Postprandial plasma glucose following a high-fat, high-calorie challenge meal (area under curve)
Time Frame
0, 9 wk
Title
Postprandial plasma triglycerides
Description
Postprandial plasma triglycerides following a high-fat, high-calorie challenge meal (area under curve)
Time Frame
0, 9 wk
Title
Postprandial lipopolysaccharide binding protein (LBP)
Description
Postprandial plasma LBP following a high-fat, high-calorie challenge meal (area under curve)
Time Frame
0, 9 wk
Title
Postprandial lipopolysaccharide (LPS)
Description
Postprandial plasma LPS following a high-fat, high-calorie challenge meal determined by limulus amebocyte lysate assay (area under curve)
Time Frame
0, 9 wk
Title
Postprandial lipopolysaccharide binding protein (LBP)/soluble cluster of differentiation 14 (sCD14) ratio
Description
Postprandial LBP/sCD14 ratio following a high-fat, high-calorie challenge meal (area under curve)
Time Frame
0, 9 wk
Title
Postprandial plasma insulin
Description
Postprandial plasma insulin following a high-fat, high-calorie challenge meal (area under curve)
Time Frame
0, 9 wk
Title
Energy intake (kcal)
Description
Self-reported food intake determined by dietary records
Time Frame
0, 9 wk
Title
Total fat (g)
Description
Self-reported nutrient intake determined by dietary records
Time Frame
0, 9 wk
Title
Carbohydrate (g)
Description
Self-reported nutrient intake determined by dietary records
Time Frame
0, 9 wk
Title
Total protein (g)
Description
Self-reported nutrient intake determined by dietary records
Time Frame
0, 9 wk
Title
Total fat (%)
Description
Self-reported nutrient intake determined by dietary records
Time Frame
0, 9 wk
Title
Carbohydrate (%)
Description
Self-reported nutrient intake determined by dietary records
Time Frame
0, 9 wk
Title
Total protein (%)
Description
Self-reported nutrient intake determined by dietary records
Time Frame
0, 9 wk
Title
Cholestrol (mg)
Description
Self-reported nutrient intake determined by dietary records
Time Frame
0, 9 wk
Title
Saturated fatty acids (g)
Description
Self-reported nutrient intake determined by dietary records
Time Frame
0, 9 wk
Title
Vitamin D (μg)
Description
Self-reported nutrient intake determined by dietary records
Time Frame
0, 9 wk
Title
Calcium (mg)
Description
Self-reported nutrient intake determined by dietary records
Time Frame
0, 9 wk
Title
Sodium (mg)
Description
Self-reported nutrient intake determined by dietary records
Time Frame
0, 9 wk
Title
Potassium (mg)
Description
Self-reported nutrient intake determined by dietary records
Time Frame
0, 9 wk
Title
Total sugars (g)
Description
Self-reported nutrient intake determined by dietary records
Time Frame
0, 9 wk
Title
Added sugars (g)
Description
Self-reported nutrient intake determined by dietary records
Time Frame
0, 9 wk
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
premenopausal women
BMI from 18.5-27 and 30-40 kg/m2
resting blood pressure <140/90 mmHg
not taking medication to control hypertension
stable body weight for the previous 2 months
willing to maintain a normal exercise level and avoid exercise 24 h prior to blood sampling
willing to avoid yogurt and probiotic-containing foods or consume 2 servings of yogurt for the duration of the study
Exclusion Criteria:
previous diagnoses of cardiovascular disease (CVD), diabetes, or arthritis (except for osteo-arthritis)
currently being treated for cancer (i.e., chemotherapy, radiation therapy)
prescribed estrogen replacement therapy
practicing weight-loss, vegetarian, kosher, or vegan diets
currently taking dietary supplements
exceed alcohol consumption more than moderate drinking (1 drink/day or a total of 7/week)
actively using antibiotics
taking anti-inflammatory drugs
have allergies to soy, egg or milk
perimenopausal or menopausal symptoms
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley W Bolling, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Food Science, Babcock Hall
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53706
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29767743
Citation
Pei R, DiMarco DM, Putt KK, Martin DA, Chitchumroonchokchai C, Bruno RS, Bolling BW. Premeal Low-Fat Yogurt Consumption Reduces Postprandial Inflammation and Markers of Endotoxin Exposure in Healthy Premenopausal Women in a Randomized Controlled Trial. J Nutr. 2018 Jun 1;148(6):910-916. doi: 10.1093/jn/nxy046. Erratum In: J Nutr. 2018 Oct 1;148(10):1698.
Results Reference
derived
PubMed Identifier
29179781
Citation
Pei R, DiMarco DM, Putt KK, Martin DA, Gu Q, Chitchumroonchokchai C, White HM, Scarlett CO, Bruno RS, Bolling BW. Low-fat yogurt consumption reduces biomarkers of chronic inflammation and inhibits markers of endotoxin exposure in healthy premenopausal women: a randomised controlled trial. Br J Nutr. 2017 Dec;118(12):1043-1051. doi: 10.1017/S0007114517003038. Epub 2017 Nov 28.
Results Reference
derived
Learn more about this trial
Reduction of Obesity-Associated Intestinal Inflammation by Low-Fat Dairy Yogurt
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