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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Active study product 		Participants receive 120 g of the yogurt drink once daily for 8 weeks.
  • Dietary Supplement: 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.
  • Dietary Supplement: Acidified lactic beverage
    Participants receive 120 g of the acidified lactic beverage once daily for 8 weeks.

Recruiting Locations

Atlantia Clinical Trials
Chicago, Illinois 60611
Contact:
Stacey Boetto, Principal Investigator
312-535-9440
sboetto@atlantiatrials.com

More Details

Status
Recruiting
Sponsor
Meiji Co., Ltd.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.