Obesity, Inflammation
Conditions
Keywords
yogurt, obesity, intestine
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.
Interventions
OTHERYogurt
Low-fat flavored yogurt
OTHERControl food
Low-fat flavored soy pudding
Sponsors
National Dairy Council
University of Massachusetts, Amherst
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Th17 proportion | Baseline, Week 4, Week 8, Week 12 | Change in proportions of circulating Th17 cells (change in control vs. change in yogurt) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fecal tumor necrosis factor alpha (TNF-alpha) | Baseline, Week 4, Week 8, Week 12 | Change in fecal TNF-alpha (change in control vs. change in yogurt) |
| Change in Th17 subpopulation (IL-17A+ IFNδ+) | Baseline, Week 4, Week 8, Week 12 | Change in proportion of circulating Th17 subpopulation (IL-17A+ IFNδ+) (change in control vs. change in yogurt) |
| Change in Th17 subpopulation (IL-17A+ IL-22+) | Baseline, Week 4, Week 8, Week 12 | Change in proportion of circulating Th17 subpopulation (IL-17A+ IL-22+) (change in control vs. change in yogurt) |
| Change in Th17 subpopulation (IL-17A+ FoxP3+) | Baseline, Week 4, Week 8, Week 12 | Change in proportion of circulating Th17 subpopulation (IL-17A+ FoxP3+) (change in control vs. change in yogurt) |
| Change in Th17 subpopulation (IL-17A+ IL-10+) | Baseline, Week 4, Week 8, Week 12 | Change in proportion of circulating Th17 subpopulation (IL-17A+ IL-10+) (change in control vs. change in yogurt) |
| Change in plasma tumor necrosis factor alpha (TNF-alpha) | Baseline, Week 4, Week 8, Week 12 | Change in fasting plasma TNF-alpha (change in control vs. change in yogurt) |
| Change in plasma interferon gamma (IFN-gamma) | Baseline, Week 4, Week 8, Week 12 | Change in fasting plasma IFN-gamma (change in control vs. change in yogurt) |
| Change in plasma interleukin-6 (IL-6) | Baseline, Week 4, Week 8, Week 12 | Change in fasting plasma IL-6 (change in control vs. change in yogurt) |
| Change in plasma interleukin-17A (IL-17A) | Baseline, Week 4, Week 8, Week 12 | Change in fasting plasma IL-17A (change in control vs. change in yogurt) |
| Change in plasma transforming growth factor beta (TGF-beta) | Baseline, Week 4, Week 8, Week 12 | Change in fasting plasma TGF-beta (change in control vs. change in yogurt) |
| Change in retinoic acid receptor-related orphan nuclear receptor gamma T (RORgammaT) expression | Baseline, Week 4, Week 8, Week 12 | Change in fasting plasma RORgammaT expression (change in control vs. change in yogurt) |
| Change in Forkhead box P3 (FoxP3) expression | Baseline, Week 4, Week 8, Week 12 | Change in fasting FoxP3 expression (change in control vs. change in yogurt) |
| Change in fecal calprotectin | Baseline, Week 4, Week 8, Week 12 | Change in fecal calprotectin (change in control vs. change in yogurt) |
| Change in plasma interleukin-4 | Baseline, Week 4, Week 8, Week 12 | Change in fasting plasma IL-4 (change in control vs. change in yogurt) |
| Change in fecal interleukin 1 alpha (IL-1alpha) | Baseline, Week 4, Week 8, Week 12 | Change in fecal IL-1alpha (change in control vs. change in yogurt) |
| Change in fecal interleukin 1beta (IL-1beta) | Baseline, Week 4, Week 8, Week 12 | Change in fecal IL-1beta (change in control vs. change in yogurt) |
| Change in fecal interleukin-6 (IL-6) | Baseline, Week 4, Week 8, Week 12 | Change in fecal IL-6 (change in control vs. change in yogurt) |
| Change in fecal interleukin-17A (IL-17A) | Baseline, Week 4, Week 8, Week 12 | Change in fecal IL-17A (change in control vs. change in yogurt) |
| Change in plasma interleukin-22 (IL-22) | Baseline, Week 4, Week 8, Week 12 | Change in fasting plasma IL-22 (change in control vs. change in yogurt) |
| Change in plasma interleukin-10 (IL-10) | Baseline, Week 4, Week 8, Week 12 | Change in fasting plasma IL-10 (change in control vs. change in yogurt) |
| Change in Treg proportion | Baseline, Week 4, Week 8, Week 12 | Change in proportion of circulating Treg cells (change in control vs. change in yogurt) |
| Change in Treg subpopulation | Baseline, Week 4, Week 8, Week 12 | Change in proportion of circulating Treg subpopulation (FoxP3+ IL-10+) (change in control vs. change in yogurt) |
| Change in Th17 subpopulation (IL-17A+ TNFα+) | Baseline, Week 4, Week 8, Week 12 | Change in proportion of circulating Th17 subpopulation (IL-17A+ TNFα+) (change in control vs. change in yogurt) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in diastolic blood pressure | Baseline, Week 4, Week 8, Week 12 | Change in resting diastolic blood pressure (change in control vs. change in yogurt) |
| Change in BMI | Baseline, Week 4, Week 8, Week 12 | Body mass index (change in control vs. change in yogurt) |
| Change in Weight | Baseline, Week 4, Week 8, Week 12 | Change in body weight (change in control vs. change in yogurt) |
| Change in waist circumference | Baseline, Week 4, Week 8, Week 12 | Change in waist circumference (change in control vs. change in yogurt) |
| Compliance: Number of lids and Unused Containers | Baseline, Week 4, Week 8, Week 12 | Number of lids and unused containers of intervention foods (control vs. yogurt) |
| Dietary records | 2 Weeks Prior to Intervention, Weeks 0-4, Weeks 4-8, Weeks 8-12 | Comparison of dietary records (control vs. yogurt) |
| Change in gut microbiota diversity | Baseline, Week 4, Week 8, Week 12 | Change in gut microbiota beta diversity (change in control vs. change in yogurt) |
| Change in fecal water ex vivo barrier disrupting activity | Baseline, Week 4, Week 8, Week 12 | Change in barrier disrupting activity of fecal water applied to cultured Caco-2 cells (change in control vs. change in yogurt) |
| Change in fecal total organic carbon | Baseline, Week 4, Week 8, Week 12 | Change in total organic carbon (change in control vs. change in yogurt) |
| Change in fecal butyrate | Baseline, Week 4, Week 8, Week 12 | Change in fecal butyrate (change in control vs. change in yogurt) |
| Change in fecal propionate | Baseline, Week 4, Week 8, Week 12 | Change in fecal propionate (change in control vs. change in yogurt) |
| Change in fecal acetate | Baseline, Week 4, Week 8, Week 12 | Change in fecal acetate (change in control vs. change in yogurt) |
| Change in fecal bile acid (deoxycholic acid) | Baseline, Week 4, Week 8, Week 12 | Change in fecal deoxycholic acid (change in control vs. change in yogurt) |
| Change in fecal bile acid (lithocholic acid) | Baseline, Week 4, Week 8, Week 12 | Change in fecal lithocholic acid (change in control vs. change in yogurt) |
| Change in fecal bile acid (hyodeoxycholic acid) | Baseline, Week 4, Week 8, Week 12 | Change in fecal hyodeoxycholic acid (change in control vs. change in yogurt) |
| Change in fecal bile acid (3β,12α-Dihydroxy-5β-cholan-24-oic acid) | Baseline, Week 4, Week 8, Week 12 | Change in fecal 3β,12α-Dihydroxy-5β-cholan-24-oic acid (change in control vs. change in yogurt) |
| Change in systolic blood pressure | Baseline, Week 4, Week 8, Week 12 | Change in resting systolic blood pressure (change in control vs. change in yogurt) |
Countries
United States
Outcome results
None listed