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.
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.
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- 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
- Recruiting
Atlantia Clinical Trials
Chicago, Illinois, 60611
Stacey Boetto, Principal Investigator, 312-535-9440, sboetto@atlantiatrials.com
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 group | Role | What they receive |
|---|---|---|
| Active study product | Experimental | Participants receive 120 g of the yogurt drink once daily for 8 weeks. Receives: Dietary Supplement: Yogurt drink |
| Placebo study product | Placebo comparator | Participants 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.
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)
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
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)
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)
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)
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)
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)
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)
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)
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)
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.
- First posted2 Sep 2026
- Study start14 Sep 2026 (estimated)
- Primary completion28 Jun 2027 (estimated)
- Study completion28 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Meiji Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07799207
- Acronym / sponsor ID
- AFCRO-198
- Conditions
- Immune Function
- Keywords
- Yogurt, Immune Function, Probiotics, Healthy Adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Meiji Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2026 (estimated)
- Primary completion
- 28 Jun 2027 (estimated)
- Study completion
- 28 Jun 2027 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active study product | Experimental | Dietary Supplement: Yogurt drinkParticipants receive 120 g of the yogurt drink once daily for 8 weeks. |
| Placebo study product | Placebo comparator | Dietary Supplement: Acidified lactic beverageParticipants receive 120 g of the acidified lactic beverage once daily for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yogurt drinkParticipants receive 120 g of the yogurt drink once daily for 8 weeks. | Dietary supplement | Active study product |
| Acidified lactic beverageParticipants receive 120 g of the acidified lactic beverage once daily for 8 weeks. | Dietary supplement | Placebo study product |
Primary outcome
Salivary IgA flow rate
Time frame: Baseline (Week 0) and Endpoint (Week 8)
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.
10 secondary outcomes
Cold-like symptoms and absenteeism
Time frame: from baseline to Week 8
Salivary IgA flow rate (baseline to 4 weeks)
Time frame: Baseline (Week 0), Midpoint (Week 4)
Salivary IgA level
Time frame: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Expression intensity and frequency of immune cell activation markers
Time frame: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Concentration of Inflammatory Cytokines in Blood
Time frame: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Gastrointestinal symptoms (GSRS - total score)
Time frame: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Quality of Life (SF-36 RAND - General Health and Energy/Fatigue Domain Scores)
Time frame: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
DASS-21- Stress Score
Time frame: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Sleep Disturbance 8A (SD 8A)
Time frame: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Sleep related impairment 8A (SRI 8A)
Time frame: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.