NCT07799207 - Effects of Continuous Yogurt Intake on Immunomodulatory Function and Subjective Health Status in Healthy U.S. Adults | Crick

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

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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.

Outcomes

Primary Outcomes

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

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

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)

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.