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Immune FunctionNCT07799207

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

A study testing Yogurt drink and Acidified lactic beverage in people with Immune Function, run by Meiji Co., Ltd. at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Immune Function
What is being tested?
Yogurt drink and Acidified lactic beverage
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
118 participants
Where
1 siteUnited States
Study dates
14 Sep 2026to 28 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Atlantia Clinical Trials

    Chicago, Illinois, 60611

    Stacey Boetto, Principal Investigator, 312-535-9440, sboetto@atlantiatrials.com

    Recruiting

Other trials in United States

About this study

Official title: Randomized, Double-Blind, Controlled Study on the Effects of Continuous Yogurt Intake on Immunomodulatory Function and Subjective Health Status in Healthy U.S. Adults

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
Being tested
Yogurt drink, Acidified lactic beverage
Keywords
Yogurt, Immune Function, Probiotics, Healthy Adults

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yogurt drinkDietary supplement

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

  • Acidified lactic beverageDietary supplement

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

Study groups in NCT07799207
Study groupRoleWhat they receive
Active study productExperimentalParticipants receive 120 g of the yogurt drink once daily for 8 weeks.
Receives: Dietary Supplement: Yogurt drink
Placebo study productPlacebo comparatorParticipants receive 120 g of the acidified lactic beverage once daily for 8 weeks.
Receives: Dietary Supplement: Acidified lactic beverage

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline (Week 0) and Endpoint (Week 8)

Secondary outcomes (10)
  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

    Measured: 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.

    Measured: 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.

    Measured: 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

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

  5. Concentration of Inflammatory Cytokines in Blood

    GCSF, GM-CS, GRO alpha/beta/gamma, GRO alpha (CXCL1), IL-1 alpha, IL-2, IL-3, IL-5, IL-6, IL-7, IL-8 (CXCL8), IL-10, IL-13, IL-15 IFN-gamma, MCP-1 (CCL2), MCP-2 (CCL8), MCP-3 (MARC/CCL7), MIG (CXCL9), RANTES (CCL5), TGF beta 1, TNF alpha, TNF beta (TNFSF1B)

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

  6. Gastrointestinal symptoms (GSRS - total score)

    The Gastrointestinal Symptom Rating Scale (GSRS) is a self-administered questionnaire used to assess the severity and frequency of gastrointestinal symptoms over the previous 7-days. The GSRS consists of a self-administered questionnaire with 15 items, which are divided into five subscales representing different symptom groups: Reflux, Abdominal Pain, Indigestion, Diarrhoea and Constipation. Each item on the GSRS is rated on a 7-point Likert scale, where 1 indicates the absence of symptoms and 7 indicates very severe symptoms. The scores for each subscale are calculated separately or can be summed for a total score, and higher scores indicate greater severity of symptoms.

    In this study, GSRS total score is used.

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

  7. Quality of Life (SF-36 RAND - General Health and Energy/Fatigue Domain Scores)

    The 36-Item Short Form Survey developed by RAND (SF-36 RAND) is a self-reported outcome measure instrument on health that is often used and well-researched. The SF-36 RAND taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. The form asks participants to reply to questions according to how they feel in general and how they have felt over the past 4 weeks. The items use Likert-type scales, some with five or six points and others with two or three points, with scores ranging from 0 to 100. Higher scores indicate higher quality of life.

    In this study, two domain scores, General Health and Energy/Fatigue, are used.

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

  8. DASS-21- Stress Score

    DASS-21 is a self-reported scale designed to measure the emotional states of depression, anxiety and stress over the previous 7-days. Each of the three DASS-21 scales contains 7 items, divided into subscale. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic nonspecific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items. The total score for stress will be assessed as part of the secondary objectives of this study.

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

  9. Sleep Disturbance 8A (SD 8A)

    The PROMIS Sleep Disturbance instruments assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. Sleep Disturbance does not focus on symptoms of specific sleep disorders, nor does it provide subjective estimates of sleep quantities (total amount of sleep, time to fall asleep, amount of wakefulness during sleep). The Sleep Disturbance short form is universal rather than disease specific. It assesses sleep disturbance over the past seven days. Each item is rated on a 5-point scale.

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

  10. Sleep related impairment 8A (SRI 8A)

    The PROMIS Sleep-Related Impairment focuses on self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. Though Sleep-Related Impairment does not directly assess cognitive, effective, or performance impairment, it does measure waking alertness, sleepiness, and function within the context of overall sleep-wake function. The Sleep-Related Impairment short form is universal rather than disease-specific. It assesses sleep-related impairment over the past seven days. Each item is rated on a 5-point scale.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2026
  2. Study start14 Sep 2026 (estimated)
  3. Primary completion28 Jun 2027 (estimated)
  4. Study completion28 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
118 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07799207
Sponsor's protocol ID
AFCRO-198
Status last verified
Sep 2026
First submitted
25 Aug 2026
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Yogurt drink and Acidified lactic beverage in people with Immune Function, run by Meiji Co., Ltd. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Salivary IgA flow rate (time frame: Baseline (Week 0) and Endpoint (Week 8)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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