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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMeiji Co., Ltd.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Yogurt drink

    Dietary supplement

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

  • Acidified lactic beverage

    Dietary supplement

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

Treatment groups

118 Participants
are divided into 2 treatment groups
Group A: Active study productExperimental treatment 1 intervention
Group B: Placebo study productPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline (Week 0) and Endpoint (Week 8)

Secondary outcomes

1

Cold-like symptoms and absenteeism

The Jackson Cold Scale (self-reported) is used to assess symptom frequency, symptom severity, symptom duration, frequency of absenteeism from school/work, and duration of absenteeism from school/work. The Jackson Cold Scale (JCS) is an assessment covering the past 24 hours of eight upper respiratory tract infection (URTI) symptoms using a four-point response range (0=absent, 1=mild, 2=moderate, and 3=severe). The total score is calculated by summing the eight symptom scores (sneezing, headache, malaise, chilliness, nasal discharge, nasal obstruction, sore throat and cough). Participants will complete this questionnaire for each day during the intervention period starting Day 0

Time frame
from baseline to Week 8
2

Salivary IgA flow rate (baseline to 4 weeks)

Saliva is collected by allowing naturally secreted saliva to passively drool into a sterile collection tube or vial without chewing or making oral movements.

Time frame
Baseline (Week 0), Midpoint (Week 4)
3

Salivary IgA level

Saliva is collected by allowing naturally secreted saliva to passively drool into a sterile collection tube or vial without chewing or making oral movements. IgA concentration in saliva is measured using ELISA.

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

Expression intensity and frequency of immune cell activation markers

CD3, CD19, CD56, CD14, CD11c, CD123, CD304, CD4, CD8, CD16, CD45RO, CCR7, CD69, CD86, HLA-DR

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

Other outcomes

Sponsors and contacts

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