Yogurt and GI Health (NCT05931471) | Clinical Trial Compass
CompletedNot Applicable
Yogurt and GI Health
United States32 participantsStarted 2023-09-19
Plain-language summary
The purpose of this research is to assess mucosal immune function responses in the gastrointestinal (GI) tract to twice-daily yogurt consumption. Previous research has shown that dairy yogurt intake can benefit gastrointestinal health. The current study will determine whether a dietary intervention with dairy yogurt will improve mucosal immunity and the gut microbiome.
Who can participate
Age range50 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 50 - 75 years
* BMI 18.5 - 39.9 kg/m2
Exclusion Criteria:
* BMI less than 18.5 or greater than 39.9
* Consumption of fermented foods or probiotics in the past two weeks
* Unwillingness to abstain from non-study fermented foods and probiotics during the trial
* Allergy to cow milk
* Lactose intolerance
* Any dietary restriction limiting or prohibiting consumption of lightly sweetened, vanilla flavored, whole milk yogurt
* Uncomfortable with or unwilling to complete stool sample collections
* Current participation in another research study
* If female,
* Currently pregnant or lactating
* Have had menstrual bleeding in the past 12 months
* Having fewer than 3 bowel movements per week
* Unmanaged hypertension, defined as blood pressure greater than or equal to 140/90 mmHg
* Current diagnosis of:
* Disease that affects the immune system, including HIV/AIDS
* Cancer
* Diabetes
* Asthma with daily medication
* Primary immune deficiency
* Auto-immune disease
* Chronic gastrointestinal disorder (e.g. Crohn's disease, irritable bowel syndrome, colitis, gastric ulcer)
* Current use for 2 weeks or longer of:
* Any drug that affects the immune system, such as immunosuppressants, immune modifying drugs, or corticosteroids (e.g. cortisone, prednisone, methylprednisolone)
* Biologics (e.g. Lantus, Remicade, Rituxan, Humira, Herceptin, Avastin, Lucentis, Enbrel)
* Use of sulfonamides or antibiotics in the past 3 months
* Use of laxatives i…
What they're measuring
1
Changes in fecal secretory immunoglobulin A
Timeframe: At end of 2-week baseline period; at 1, 2 and 3 weeks of intervention; and at end of 2-week follow-up period
Trial details
NCT IDNCT05931471
SponsorUSDA, Western Human Nutrition Research Center