Yogurt and GI Health

NCT05931471 | Completed

• 1 other identifier: FL119
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Yogurt Intake; Gastrointestinal Immune Function; Gut Microbiome; Gut Health

Keywords

Yogurt; Adults; Gut microbiome; Gut health; Immune function; GI tract

Outcome Measures

Primary Outcomes (1)

• Changes in fecal secretory immunoglobulin A

  Fecal secretory immunoglobulin A (sIgA) will be extracted then measured in duplicate by enzyme-linked immunosorbent assay (ELISA)

  At end of 2-week baseline period; at 1, 2 and 3 weeks of intervention; and at end of 2-week follow-up period

Secondary Outcomes (4)

• Changes in fecal mucin-2 mRNA expression

  At end of 2-week baseline period; at 1, 2 and 3 weeks of intervention; and at end of 2-week follow-up period

• Changes in fecal pH

  At end of 2-week baseline period; at 1, 2 and 3 weeks of intervention; and at end of 2-week follow-up period

• Changes in fecal short-chain fatty acids

  At end of 2-week baseline period; at 1, 2 and 3 weeks of intervention; and at end of 2-week follow-up period

• Fecal microbiome

  At end of 2-week baseline period; at 1, 2 and 3 weeks of intervention; and at end of 2-week follow-up period

Study Arms (1)

Yogurt Consumption

EXPERIMENTAL

Participants will complete a 2-week baseline with no yogurt intake, followed by a three-week yogurt intervention, and then a 2-week follow-up period with no yogurt intake.

Other: Yogurt Intervention

Interventions

Yogurt Intervention OTHER

Participants 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.

Yogurt Consumption

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50 - 75 years
• BMI 18.5 - 39.9 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• USDA, Western Human Nutrition Research Center: lead

Study Sites (1)

USDA Western Human Nutrition Research Center

Davis, California, 95616, United States

Location

Study Officials

• Danielle G Lemay, PhD

  USDA, Western Human Nutrition Research Center

  PRINCIPAL INVESTIGATOR

• Bess L Caswell, PhD

  USDA, Western Human Nutrition Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 5, 2023
• Study Start: September 19, 2023
• Primary Completion: June 21, 2024
• Study Completion: June 21, 2024
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: At the time of study publication, de-identified IPD will be permanently archived on a publicly accessible platform.
• Access Criteria: De-identified IPD and supporting information will be publicly available.

Locations

US (1)