Clinical trial NCT04149418: Yogurt for Prevention of Chronic Inflammation
Official title: Anti-inflammatory Activity of Yogurt Mediated by the Intestine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Inflammation
Keywords: yogurt
obesity
intestine
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Dairy Council
name: University of Massachusetts, Amherst
First posted: 2019-11-04
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to conduct a randomized cross-over dietary intervention in adult women who are overweight or obese to compare how yogurt and a control food affect biomarkers of inflammation and intestinal health.


Eligibility criteria: Inclusion Criteria:

* healthy premenopausal women age 21-55
* BMI ≥ 25 kg/m2
* not taking medication to control hypertension (e.g. anti-hypertensives or diuretics)
* resting blood pressure \<140/90 mmHg
* stable body weight for past two months
* willing to maintain a normal exercise level (in general)
* willing to avoid exercise and smoking (or other forms of nicotine intake) for 24 h prior to blood collection
* willing to avoid caffeine for 12 h before study visits
* willing to fast 12 h prior to study visits
* willing to avoid dietary supplements, yogurt and probiotic-containing foods (as necessary) and consume 12 oz. of yogurt and the control food per day (as necessary) for the duration of the study

Exclusion Criteria:

* self-reported previous diagnoses of an inflammatory disease (e.g. inflammatory bowel disease, asthma, arthritis), CVD, diabetes, current cancer treatment (i.e., chemotherapy, radiation therapy)
* have used oral antibiotics in the prior 21 days before sample collection
* actively trying to lose weight
* regularly taking anti-inflammatory drugs
* vegetarian or allergic to soy or dairy
* are pregnant, lactating, or trying to become pregnant

Primary outcomes:
measure: Change in Th17 proportion
timeFrame: Baseline, Week 4, Week 8, Week 12
Secondary outcomes:
measure: Change in Treg proportion
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in Treg subpopulation
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in Th17 subpopulation (IL-17A+ TNFα+)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in Th17 subpopulation (IL-17A+ IFNδ+)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in Th17 subpopulation (IL-17A+ IL-22+)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in Th17 subpopulation (IL-17A+ FoxP3+)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in Th17 subpopulation (IL-17A+ IL-10+)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in plasma tumor necrosis factor alpha (TNF-alpha)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in plasma interferon gamma (IFN-gamma)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in plasma interleukin-6 (IL-6)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in plasma interleukin-17A (IL-17A)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in plasma interleukin-4
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in plasma interleukin-22 (IL-22)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in plasma interleukin-10 (IL-10)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in plasma transforming growth factor beta (TGF-beta)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in retinoic acid receptor-related orphan nuclear receptor gamma T (RORgammaT) expression
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in Forkhead box P3 (FoxP3) expression
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in fecal calprotectin
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in fecal tumor necrosis factor alpha (TNF-alpha)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in fecal interleukin 1 alpha (IL-1alpha)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in fecal interleukin 1beta (IL-1beta)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in fecal interleukin-6 (IL-6)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in fecal interleukin-17A (IL-17A)
timeFrame: Baseline, Week 4, Week 8, Week 12
Other outcomes:
measure: Change in systolic blood pressure
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in diastolic blood pressure
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in BMI
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in Weight
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in waist circumference
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Compliance: Number of lids and Unused Containers
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Dietary records
timeFrame: 2 Weeks Prior to Intervention, Weeks 0-4, Weeks 4-8, Weeks 8-12
measure: Change in gut microbiota diversity
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in fecal water ex vivo barrier disrupting activity
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in fecal total organic carbon
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in fecal butyrate
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in fecal propionate
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in fecal acetate
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in fecal bile acid (deoxycholic acid)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in fecal bile acid (lithocholic acid)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in fecal bile acid (hyodeoxycholic acid)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Change in fecal bile acid (3β,12α-Dihydroxy-5β-cholan-24-oic acid)
timeFrame: Baseline, Week 4, Week 8, Week 12
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: