Clinical trial NCT01686204: 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
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Barrier Function
Chronic Inflammation
Keywords: Yogurt
Intestine
Inflammation
Obese
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Dairy Research Institute
First posted: 2012-09-17
Enrollment: 128
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Plasma soluble cluster of differentiation 14 (sCD14)
timeFrame: 0, 3, 6, and 9 wk
Secondary outcomes:
measure: Fasting plasma interleukin-6 (IL-6)
timeFrame: 0, 3, 6, 9 wk
measure: Postprandial sCD14
timeFrame: 0 and 9 wk
measure: Postprandial interleukin-6 (IL-6)
timeFrame: 0 and 9 wk
Other outcomes:
measure: Fasting lipopolysaccharide binding protein (LBP)
timeFrame: 0 and 9 wk
measure: Fasting plasma endotoxin (LPS, lipopolysaccharide)
timeFrame: 0, 9 wk
measure: Fasting plasma core antibodies to endotoxin
timeFrame: 0 and 9 wk
measure: Fasting plasma anandamide (AEA)
timeFrame: 0, 9 wk
measure: Fasting plasma 2-arachidonoylglycerol (2-AG)
timeFrame: 0, 9 wk
measure: Fasting plasma IL-10
timeFrame: 0, 9 wk
measure: Fasting plasma high-sensitivity C-reactive protein (hsCRP)
timeFrame: 0, 9 wk
measure: Fasting plasma Tumor Necrosis Factor-alpha (TNF-α)
timeFrame: 0, 9 wk
measure: Fasting plasma Soluble TNF-Receptor II (sTNF-RII)
timeFrame: 0, 9 wk
measure: TNF-alpha/sTNF-RII ratio
timeFrame: 0, 9 wk
measure: Fasting plasma glucose
timeFrame: 0, 9 wk
measure: Fasting plasma triglycerides
timeFrame: 0, 9 wk
measure: Fasting plasma insulin
timeFrame: 0, 9 wk
measure: Fasting plasma soluble cluster of differentiation 14 (sCD14)
timeFrame: 0, 9 wk
measure: Body weight
timeFrame: 0, 3, 6, 9 wk
measure: Body mass index
timeFrame: 0, 3, 6, 9 wk
measure: Waist circumference
timeFrame: 0, 3, 6, 9 wk
measure: Systolic blood pressure
timeFrame: 0, 3, 6, 9 wk
measure: Diastolic blood pressure
timeFrame: 0, 3, 6, 9 wk
measure: Fasting RPLP0, encoding ribosomal protein large P0
timeFrame: 0, 9 wk
measure: TLR4, encoding Toll-like receptor 4
timeFrame: 0, 9 wk
measure: RELA, encoding p65 subunit of nuclear factor kappa B
timeFrame: 0, 9 wk
measure: NFKBIA, encoding nuclear factor kappa B inhibitor alpha
timeFrame: 0, 9 wk
measure: PTGS2, encoding cyclooxygenase-2 (COX-2)
timeFrame: 0, 9 wk
measure: NCF1,encoding the p47 subunit of nicotinamide adenine dinucleotide phosphate-oxidase, (NADPH oxidase)
timeFrame: 0, 9 wk
measure: TNF, encoding tumor necrosis factors (TNF)
timeFrame: 0, 9 wk
measure: IFNG, encoding interferon-γ
timeFrame: 0, 9 wk
measure: TGFB1, encoding transforming growth factor beta 1 (TGFβ1)
timeFrame: 0, 9 wk
measure: Postprandial plasma glucose
timeFrame: 0, 9 wk
measure: Postprandial plasma triglycerides
timeFrame: 0, 9 wk
measure: Postprandial lipopolysaccharide binding protein (LBP)
timeFrame: 0, 9 wk
measure: Postprandial lipopolysaccharide (LPS)
timeFrame: 0, 9 wk
measure: Postprandial lipopolysaccharide binding protein (LBP)/soluble cluster of differentiation 14 (sCD14) ratio
timeFrame: 0, 9 wk
measure: Postprandial plasma insulin
timeFrame: 0, 9 wk
measure: Energy intake (kcal)
timeFrame: 0, 9 wk
measure: Total fat (g)
timeFrame: 0, 9 wk
measure: Carbohydrate (g)
timeFrame: 0, 9 wk
measure: Total protein (g)
timeFrame: 0, 9 wk
measure: Total fat (%)
timeFrame: 0, 9 wk
measure: Carbohydrate (%)
timeFrame: 0, 9 wk
measure: Total protein (%)
timeFrame: 0, 9 wk
measure: Cholestrol (mg)
timeFrame: 0, 9 wk
measure: Saturated fatty acids (g)
timeFrame: 0, 9 wk
measure: Vitamin D (μg)
timeFrame: 0, 9 wk
measure: Calcium (mg)
timeFrame: 0, 9 wk
measure: Sodium (mg)
timeFrame: 0, 9 wk
measure: Potassium (mg)
timeFrame: 0, 9 wk
measure: Total sugars (g)
timeFrame: 0, 9 wk
measure: Added sugars (g)
timeFrame: 0, 9 wk
Locations:
city: Madison
country: United States
facility: Department of Food Science, Babcock Hall
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Bradley W Bolling, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.