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

tiistai 1. syyskuuta 2026 päivittänyt: Meiji Co., Ltd.

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.

Tutkimuksen yleiskatsaus

Tila

Rekrytointi

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

118

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Yhdysvallat
    • Illinois
      • Chicago, Illinois, Yhdysvallat, 60611
        • Rekrytointi
        • Atlantia Clinical Trials
        • Ottaa yhteyttä:

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Joo

Kuvaus

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Ennaltaehkäisy
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Nelinkertaistaa

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Active study product
Participants receive 120 g of the yogurt drink once daily for 8 weeks.
Ravintolisä: Yogurt drink
Participants receive 120 g of the yogurt drink once daily for 8 weeks.
Placebo Comparator: Placebo study product
Participants receive 120 g of the acidified lactic beverage once daily for 8 weeks.
Ravintolisä: Acidified lactic beverage
Participants receive 120 g of the acidified lactic beverage once daily for 8 weeks.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Salivary IgA flow rate
Aikaikkuna: 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.
Baseline (Week 0) and Endpoint (Week 8)

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Cold-like symptoms and absenteeism
Aikaikkuna: from baseline to Week 8

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
from baseline to Week 8
Salivary IgA flow rate (baseline to 4 weeks)
Aikaikkuna: Baseline (Week 0), Midpoint (Week 4)
Saliva is collected by allowing naturally secreted saliva to passively drool into a sterile collection tube or vial without chewing or making oral movements.
Baseline (Week 0), Midpoint (Week 4)
Salivary IgA level
Aikaikkuna: Baseline (Week 0), Midpoint (Week 4) 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. IgA concentration in saliva is measured using ELISA.
Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Expression intensity and frequency of immune cell activation markers
Aikaikkuna: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
CD3, CD19, CD56, CD14, CD11c, CD123, CD304, CD4, CD8, CD16, CD45RO, CCR7, CD69, CD86, HLA-DR
Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Concentration of Inflammatory Cytokines in Blood
Aikaikkuna: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
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)
Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Gastrointestinal symptoms (GSRS - total score)
Aikaikkuna: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)

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.
Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Quality of Life (SF-36 RAND - General Health and Energy/Fatigue Domain Scores)
Aikaikkuna: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)

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.
Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
DASS-21- Stress Score
Aikaikkuna: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
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.
Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Sleep Disturbance 8A (SD 8A)
Aikaikkuna: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
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.
Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Sleep related impairment 8A (SRI 8A)
Aikaikkuna: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
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.
Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Meiji Co., Ltd.

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Arvioitu)

Maanantai 14. syyskuuta 2026

Ensisijainen valmistuminen (Arvioitu)

Maanantai 28. kesäkuuta 2027

Opintojen valmistuminen (Arvioitu)

Maanantai 28. kesäkuuta 2027

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Tiistai 25. elokuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 28. elokuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Keskiviikko 2. syyskuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Torstai 3. syyskuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Tiistai 1. syyskuuta 2026

Viimeksi vahvistettu

Tiistai 1. syyskuuta 2026

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