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CompletedNCT05931471

Yogurt and GI Health

Effect of Yogurt on Mucosal Immunity in the Gastrointestinal Tract

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
32 (actual)
Sponsor
USDA, Western Human Nutrition Research Center · Federal
Sex
All
Age
50 Years – 75 Years
Healthy volunteers
Accepted

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.

Detailed description

The gastrointestinal (GI) tract has the difficult task of absorbing nutrients while excluding microorganisms and non-nutritive foreign agents. The GI tract is protected by components of GI mucosal immunity, such as the mucin layer, anti-microbial peptides, secretory IgA (sIgA), and more, which collectively maintain gut homeostasis. When mucosal immunity fails, the result can be gastrointestinal infection, allergic inflammation, or inflammatory bowel disease. Mechanistic knowledge from in vitro studies suggests that sIgA increases in response to lactic acid bacteria and mucin-2 expression increases in response to milk peptides in yogurt. Yogurt consumption may also reduce constipation and increase the production of short-chain fatty acids (SCFAs). SCFAs promote the health of intestinal cells by acting as an energy source, influencing gene expression, and exerting anti-inflammatory effects. When SCFAs increase, fecal pH decreases. This research will expand the limited existing literature on how GI mucosal immunity changes in response to yogurt consumption, the time frame over which effects occur and how long the effects persist after yogurt is discontinued. Participants will undergo a two-week baseline period without yogurt intake, followed by a three-week intervention of two daily 6-oz servings of dairy yogurt, and a follow-up period with no yogurt consumption. Stool samples will be collected at the end of the 2-week baseline period, after 1, 2, and 3 weeks of intervention, and at the end of the 2 weeks post-intervention period for measurement of fecal sIgA, fecal mucin-2 mRNA, fecal pH, and fecal SCFAs, and analysis of the fecal microbiome. 24-hour dietary recalls will be collected with the Automated Self-Administered Dietary Assessment Tool (ASA24) during the baseline and intervention phases of the trial. Specific knowledge will be produced regarding the effect of regular yogurt consumption on sIgA levels, mucin-2 gene expression and fecal pH in older adults (age 50 - 75 years). The study will also produce knowledge on the intervention length needed for maximal response in these outcome measures and how long these responses persist when the yogurt intervention is discontinued. The outcomes of this study will 1) provide preliminary data to inform design of future, larger studies on how dairy yogurt or similar cultured products influence GI mucosal immune function, and 2) contribute to growing knowledge on the potential health benefits of consuming fermented, particularly yogurt.

Conditions

Interventions

TypeNameDescription
OTHERYogurt InterventionParticipants will be provided with a commercial yogurt that contains only cultured dairy, traditional live active cultures (Streptococcus thermophilus, Lactobacillus delbrueckii subsp. bulgaricus, and possibly other non-brand-specific strains), sugar, and, optionally, vanilla flavor. The yogurt will contain no starches or pectin, gums, fiber or other added ingredients. Participants will be asked to consume two 6-ounce portions of yogurt each day, and to log their consumption in a provided booklet. They will be advised to incorporate the yogurt into their diet however they choose (as part of meals or as snacks), to avoid other fermented foods, and to otherwise maintain their habitual diet.

Timeline

Start date
2023-09-19
Primary completion
2024-06-21
Completion
2024-06-21
First posted
2023-07-05
Last updated
2025-03-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05931471. Inclusion in this directory is not an endorsement.

Yogurt and GI Health (NCT05931471) · Clinical Trials Directory