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

1 de setembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

118

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • Recrutamento
        • Atlantia Clinical Trials
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Active study product
Participants receive 120 g of the yogurt drink once daily for 8 weeks.
Suplemento dietético: Yogurt drink
Participants receive 120 g of the yogurt drink once daily for 8 weeks.
Comparador de Placebo: Placebo study product
Participants receive 120 g of the acidified lactic beverage once daily for 8 weeks.
Suplemento dietético: Acidified lactic beverage
Participants receive 120 g of the acidified lactic beverage once daily for 8 weeks.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Salivary IgA flow rate
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Cold-like symptoms and absenteeism
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Meiji Co., Ltd.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

14 de setembro de 2026

Conclusão Primária (Estimado)

28 de junho de 2027

Conclusão do estudo (Estimado)

28 de junho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

25 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de agosto de 2026

Primeira postagem (Real)

2 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

3 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • AFCRO-198

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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