Effects of Continuous Yogurt Intake on Immunomodulatory Function and Subjective Health Status in Healthy U.S. Adults

NCT07799207 | Recruiting

• 1 other identifier: AFCRO-198
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effects of daily consumption of a yogurt on immune function and subjective health status in healthy adults in the United States. Participants are randomly assigned to receive either the active yogurt or a placebo once daily for 8 weeks. The study assesses immune function using salivary immunoglobulin A and other immune-related biomarkers. The study also evaluates cold-like symptoms, quality of life, gastrointestinal symptoms, stress, and sleep-related outcomes.

Conditions

Immune Function

Keywords

Yogurt; Immune Function; Probiotics; Healthy Adults

Outcome Measures

Primary Outcomes (1)

• Salivary IgA flow rate

  Saliva is collected by allowing naturally secreted saliva to passively drool into a sterile collection tube or vial without chewing or making oral movements. The time required to collect the specified volume of saliva is recorded. The salivary IgA flow rate is calculated by multiplying the salivary IgA level by the slivary flow rate.

  Baseline (Week 0) and Endpoint (Week 8)

Secondary Outcomes (10)

• Cold-like symptoms and absenteeism

  from baseline to Week 8

• Salivary IgA flow rate (baseline to 4 weeks)

  Baseline (Week 0), Midpoint (Week 4)

• Salivary IgA level

  Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)

• Expression intensity and frequency of immune cell activation markers

  Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)

• Concentration of Inflammatory Cytokines in Blood

  Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)

Study Arms (2)

Active study product

EXPERIMENTAL

Participants receive 120 g of the yogurt drink once daily for 8 weeks.

Dietary Supplement: Yogurt drink

Placebo study product

PLACEBO COMPARATOR

Participants receive 120 g of the acidified lactic beverage once daily for 8 weeks.

Dietary Supplement: Acidified lactic beverage

Interventions

Yogurt drink DIETARY_SUPPLEMENT

Participants receive 120 g of the yogurt drink once daily for 8 weeks.

Active study product

Acidified lactic beverage DIETARY_SUPPLEMENT

Participants receive 120 g of the acidified lactic beverage once daily for 8 weeks.

Placebo study product

Eligibility Criteria

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

You may qualify if:

• Be able to give written informed consent.
• Be between 18-65 years, inclusive.
• Be in general good health, as determined by the in investigator.
• Willing to consume study product daily for the duration of the study.
• Has a body mass index (BMI) ≤39.9 kg/m2
• Willing to refrain from consuming alcohol for the 24 hours prior to each study visit.
• Willing to maintain current lifestyle habits, including dietary and caffeine and alcohol intake, for the duration of the study.

You may not qualify if:

• Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
• Participants currently of biological childbearing potential, but not using a continuous effective method of contraception.
• Has a history of drug and/or alcohol abuse at the time of enrolment.
• Drinks more than nationally recommended units of alcohol per day/week.
• Has milk allergy or other food allergies or other issues with foods that would preclude intake of the SP.
• Has an excessive smoking habit.
• Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and laboratory test results.
• Dental or intraoral treatment.
• Visited a hospital or clinic for allergic rhinitis (pollinosis) within the past year or those who plan to take prescription drugs to treat or prevent allergic rhinitis during the study period.
• Current or recent (in the past 4 weeks) use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results.
• Current or recent (in the past 4-weeks) use of prohibited nutritional or non-nutritional dietary supplements that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results.
• Current or recent (in the past 2 weeks) use of yogurt (other than the study product)
• Participants who have donated blood in the previous 8-weeks.
• Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
• Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.

Sponsors & Collaborators

• Meiji Co., Ltd.: lead

Study Sites (1)

Atlantia Clinical Trials

Chicago, Illinois, 60611, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 2, 2026
• Study Start: September 14, 2026
• Primary Completion (Estimated): June 28, 2027
• Study Completion (Estimated): June 28, 2027
• Last Updated: September 3, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)