Verification on the immunomodulatory effects of continuous consumption of dairy products

UMIN ID: UMIN000053187

Registered date:12/01/2024

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Healthy adult
• Date of first enrollment: 2024/01/13
• Target sample size: 140
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Consume test food once a day for 8 weeks.
Consume placebo food once a day for 8 weeks.

Outcome(s)

• Primary Outcome: Immune function

Key inclusion & exclusion criteria

• Age minimum: 35years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude criteria: 1.Subjects suffering from, undergoing treatment for, or with a history of diabetes, renal or hepatic disease, heart disease or other serious illness, thyroid disease, adrenal disease, or other metabolic diseases. 2.Subjects with chronic diseases and use drug regularly. 3.Subjects with a history or current history of drug or alcohol dependence. 4.Subjects who have been regularly using (more than three days a week) food containing lactic acid bacteria such as yogurt, lactic acid bacteria beverages, food for specified health uses, food with nutrient function claims, health food or supplements. 5.Subjects whose average daily alcohol consumption exceeds 40 g per day (1,000 mL of alcohol drink at 5% alcohol). 6.Subjects who are unable to abstain from alcohol for one day prior to each inspection day. 7.Subjects who have habit of smoking. 8.Subjects who have hay fever. 9.Subjects with a history of gastrointestinal diseases affecting digestion and absorption and gastrointestinal surgery (except appendicitis). 10.Subjects with dental or oral problems that involve bleeding and are the symptoms likely to continue during the study period. 11.Subjects who scheduled for vaccination during the study period. 12.Subjects whose hemoglobin levels are below 12 g/dl for male and 11 g/dl for female in the blood test at the time of the screening test. 13.Subjects who test positive for infectious diseases at the time of the screening test. 14.Subjects who are pregnant, planning or wishing to be pregnant during the study period, and are breastfeeding. 15.Subjects prone to diarrhea when consuming dairy products. 16.Subjects with food allergy. 17.Subjects who have participated in other clinical studies in the month prior to the screening test, and plan or wish to participate in other clinical studies during the study period. 18.Subjects who are judged as unsuitable for this study by the investigator for other reasons.

Related Information

• Primary Sponsor: Meiji Co., Ltd
• Source(s) of Monetary Support: Meiji Co., Ltd