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ObesityNCT04149418

Yogurt for Prevention of Chronic Inflammation

A study testing Yogurt in people with Obesity and Inflammation, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity, Inflammation
What is being tested?
Yogurt
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
15 Oct 2021to 1 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 55 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Department of Food Science, Babcock Hall

    Madison, Wisconsin, 53706

Other trials in United States

About this study

Official title: Anti-inflammatory Activity of Yogurt Mediated by the Intestine

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.

Being tested
Yogurt, Control food
Keywords
yogurt, obesity, intestine
Medical subject headings
Obesity, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YogurtOther

    Low-fat flavored yogurt

  • Control foodOther

    Low-fat flavored soy pudding

Study groups in NCT04149418
Study groupRoleWhat they receive
Yogurt-ControlExperimentalConsumption of 12 oz. of low-fat yogurt daily (2 x 6 oz. servings) for 4 weeks, followed by a washout phase for 4 weeks, then consumption of 12 oz. control food (flavored soy pudding, 2 x 6 oz. servings) for 4 weeks.
Receives: Other: Yogurt; Other: Control food
Control-YogurtExperimentalConsumption of control food (flavored soy pudding, 2 x 6 oz. servings), followed by a washout phase for 4 weeks, then consumption of 12 oz. of low-fat yogurt daily (2 x 6 oz. servings) for 4 weeks.
Receives: Other: Yogurt; Other: Control food

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Th17 proportion

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

    Measured: Baseline, Week 4, Week 8, Week 12

Secondary outcomes (23)

  1. Change in Treg proportion

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

    Measured: Baseline, Week 4, Week 8, Week 12

  2. Change in Treg subpopulation

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

    Measured: Baseline, Week 4, Week 8, Week 12

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

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

    Measured: Baseline, Week 4, Week 8, Week 12

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

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

    Measured: Baseline, Week 4, Week 8, Week 12

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

    Change in proportion of circulating Th17 subpopulation (IL-17A+ IL-22+) (change in control vs. change in yogurt)

    Measured: Baseline, Week 4, Week 8, Week 12

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

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

    Measured: Baseline, Week 4, Week 8, Week 12

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

    Change in proportion of circulating Th17 subpopulation (IL-17A+ IL-10+) (change in control vs. change in yogurt)

    Measured: Baseline, Week 4, Week 8, Week 12

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

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

    Measured: Baseline, Week 4, Week 8, Week 12

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

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

    Measured: Baseline, Week 4, Week 8, Week 12

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

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

    Measured: Baseline, Week 4, Week 8, Week 12

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

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

    Measured: Baseline, Week 4, Week 8, Week 12

  12. Change in plasma interleukin-4

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

    Measured: Baseline, Week 4, Week 8, Week 12

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

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

    Measured: Baseline, Week 4, Week 8, Week 12

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

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

    Measured: Baseline, Week 4, Week 8, Week 12

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

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

    Measured: Baseline, Week 4, Week 8, Week 12

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

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

    Measured: Baseline, Week 4, Week 8, Week 12

  17. Change in Forkhead box P3 (FoxP3) expression

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

    Measured: Baseline, Week 4, Week 8, Week 12

  18. Change in fecal calprotectin

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

    Measured: Baseline, Week 4, Week 8, Week 12

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

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

    Measured: Baseline, Week 4, Week 8, Week 12

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

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

    Measured: Baseline, Week 4, Week 8, Week 12

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

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

    Measured: Baseline, Week 4, Week 8, Week 12

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

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

    Measured: Baseline, Week 4, Week 8, Week 12

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

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

    Measured: Baseline, Week 4, Week 8, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2019
  2. Study start15 Oct 2021
  3. Primary completion1 Sep 2022
  4. Study completion1 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04149418
Sponsor's protocol ID
2018-1262
Other IDs
A074000, AG&LSC/FOOD SCIENCE/FOOD SCIEN, Protocol Version 1/10/2019
Status last verified
Nov 2022
First submitted
29 Oct 2019
Last updated
16 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hasegawa Y, Noll AL, Lang DJ, Akfaly EM, Liu Z, Bolling BW. Low-fat yogurt consumption maintains biomarkers of immune function relative to nondairy control food in women with elevated BMI: A randomized controlled crossover trial. Nutr Res. 2024 Sep;129:1-13. doi: 10.1016/j.nutres.2024.07.005. Epub 2024 Jul 24.

    PubMed 39153426

Questions about this trial

What is this clinical trial studying?

A study testing Yogurt in people with Obesity and Inflammation, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Th17 proportion (time frame: Baseline, Week 4, Week 8, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04149418, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.

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