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Completed

NCT Number: NCT04149418

Yogurt for Prevention of Chronic Inflammation

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.

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Key information

Conditions

Obesity Body Weight Inflammation Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Food Science, Babcock Hall

Madison, Wisconsin, 53706, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yogurt

Other

Low-fat flavored yogurt

Control Food

Other

Low-fat flavored soy pudding

Primary outcomes

  1. Change in Th17 proportion

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in proportions of circulating Th17 cells (change in control vs. change in yogurt)

Secondary outcomes

  1. Change in Treg proportion

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in proportion of circulating Treg cells (change in control vs. change in yogurt)

  2. Change in Treg subpopulation

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in proportion of circulating Treg subpopulation (FoxP3+ IL-10+) (change in control vs. change in yogurt)

  3. Change in Th17 subpopulation (IL-17A+ TNFα+)

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in proportion of circulating Th17 subpopulation (IL-17A+ TNFα+) (change in control vs. change in yogurt)

  4. Change in Th17 subpopulation (IL-17A+ IFNδ+)

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in proportion of circulating Th17 subpopulation (IL-17A+ IFNδ+) (change in control vs. change in yogurt)

  5. Change in Th17 subpopulation (IL-17A+ IL-22+)

    Time frame: 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)

  6. Change in Th17 subpopulation (IL-17A+ FoxP3+)

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in proportion of circulating Th17 subpopulation (IL-17A+ FoxP3+) (change in control vs. change in yogurt)

  7. Change in Th17 subpopulation (IL-17A+ IL-10+)

    Time frame: 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)

  8. Change in plasma tumor necrosis factor alpha (TNF-alpha)

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in fasting plasma TNF-alpha (change in control vs. change in yogurt)

  9. Change in plasma interferon gamma (IFN-gamma)

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in fasting plasma IFN-gamma (change in control vs. change in yogurt)

  10. Change in plasma interleukin-6 (IL-6)

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in fasting plasma IL-6 (change in control vs. change in yogurt)

  11. Change in plasma interleukin-17A (IL-17A)

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in fasting plasma IL-17A (change in control vs. change in yogurt)

  12. Change in plasma interleukin-4

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in fasting plasma IL-4 (change in control vs. change in yogurt)

  13. Change in plasma interleukin-22 (IL-22)

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in fasting plasma IL-22 (change in control vs. change in yogurt)

  14. Change in plasma interleukin-10 (IL-10)

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in fasting plasma IL-10 (change in control vs. change in yogurt)

  15. Change in plasma transforming growth factor beta (TGF-beta)

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in fasting plasma TGF-beta (change in control vs. change in yogurt)

  16. Change in retinoic acid receptor-related orphan nuclear receptor gamma T (RORgammaT) expression

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in fasting plasma RORgammaT expression (change in control vs. change in yogurt)

  17. Change in Forkhead box P3 (FoxP3) expression

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in fasting FoxP3 expression (change in control vs. change in yogurt)

  18. Change in fecal calprotectin

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in fecal calprotectin (change in control vs. change in yogurt)

  19. Change in fecal tumor necrosis factor alpha (TNF-alpha)

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in fecal TNF-alpha (change in control vs. change in yogurt)

  20. Change in fecal interleukin 1 alpha (IL-1alpha)

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in fecal IL-1alpha (change in control vs. change in yogurt)

  21. Change in fecal interleukin 1beta (IL-1beta)

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in fecal IL-1beta (change in control vs. change in yogurt)

  22. Change in fecal interleukin-6 (IL-6)

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in fecal IL-6 (change in control vs. change in yogurt)

  23. Change in fecal interleukin-17A (IL-17A)

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in fecal IL-17A (change in control vs. change in yogurt)

Other outcomes

  1. Change in systolic blood pressure

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in resting systolic blood pressure (change in control vs. change in yogurt)

  2. Change in diastolic blood pressure

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in resting diastolic blood pressure (change in control vs. change in yogurt)

  3. Change in BMI

    Time frame: Baseline, Week 4, Week 8, Week 12

    Body mass index (change in control vs. change in yogurt)

  4. Change in Weight

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in body weight (change in control vs. change in yogurt)

  5. Change in waist circumference

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in waist circumference (change in control vs. change in yogurt)

  6. Compliance: Number of lids and Unused Containers

    Time frame: Baseline, Week 4, Week 8, Week 12

    Number of lids and unused containers of intervention foods (control vs. yogurt)

  7. Dietary records

    Time frame: 2 Weeks Prior to Intervention, Weeks 0-4, Weeks 4-8, Weeks 8-12

    Comparison of dietary records (control vs. yogurt)

  8. Change in gut microbiota diversity

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in gut microbiota beta diversity (change in control vs. change in yogurt)

  9. Change in fecal water ex vivo barrier disrupting activity

    Time frame: 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)

  10. Change in fecal total organic carbon

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in total organic carbon (change in control vs. change in yogurt)

  11. Change in fecal butyrate

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in fecal butyrate (change in control vs. change in yogurt)

  12. Change in fecal propionate

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in fecal propionate (change in control vs. change in yogurt)

  13. Change in fecal acetate

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in fecal acetate (change in control vs. change in yogurt)

  14. Change in fecal bile acid (deoxycholic acid)

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in fecal deoxycholic acid (change in control vs. change in yogurt)

  15. Change in fecal bile acid (lithocholic acid)

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in fecal lithocholic acid (change in control vs. change in yogurt)

  16. Change in fecal bile acid (hyodeoxycholic acid)

    Time frame: Baseline, Week 4, Week 8, Week 12

    Change in fecal hyodeoxycholic acid (change in control vs. change in yogurt)

  17. Change in fecal bile acid (3β,12α-Dihydroxy-5β-cholan-24-oic acid)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Dairy Council
  • University of Massachusetts, Amherst

Registry information

Official study title

Anti-inflammatory Activity of Yogurt Mediated by the Intestine

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 4, 2019
Registry last updated
Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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