Exploratory Study on the Effects of Ingestion of Lactobacillus Material on the Maintenance of Physical Condition

UMIN ID: UMIN000056115

Registered date:12/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy adult
• Date of first enrollment: 2024/11/13
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Consume test food once a day for 4 weeks.
Consume placebo food once a day for 4 weeks.

Outcome(s)

• Primary Outcome: Physical condition questionnaire
• Secondary Outcome: Immune function, QOL-related questionnaire

Key inclusion & exclusion criteria

• Age minimum: 35years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude criteria: 1.Those with chronic diseases and use drug regularly. 2.Those have/ had diabetes, autoimmune disease, thyroid disease, adrenal disease. 3.Those with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring official reports. 4.Those with major surgical history related to the digestive system. 5.Those with seriously abnormal blood pressure, physical data or hematologic data. 6.Pregnant or lactating women or those planning to become pregnant. 7.Those who may have allergic reactions to drugs, foods or plants (esp. milk). 8.Those prone to diarrhea from dairy products. 9.Those who experienced discomfort during blood draw. 10.Those undergoing dental treatment or have dental/ oral issues involving bleeding at the time of the screening test, and whose symptoms are expected to continue throughout the study. 11.Pre- or post-menopausal women with obvious physical changes. 12.Those at risk of allergic reactions during the study. 13.Those who regularly taking health foods that affect this study at least 4 days per wk during the month prior to the screening test. 14.Those who regularly taking supplements at least 6 days per wk during the month prior to the screening test. 15.Those unable to stop taking foods claiming to maintain physical condition or immune function, yogurt, health foods, or supplements during the study. 16.Those have smoked within the past six mos. 17.Alcohol addicts. 18.Those with disordered lifestyle 19.Those planning to vaccination between the screening test and the final test. 20.Those planning to go abroad during the study. 21.Those who donated either 400 ml whole blood within 16 wks (women), 12 wks (men), 200 ml whole blood within 4 wks (both), or blood components within 2 wks (both), prior to the study. 22.Those participating or wish to participate in other clinical studies between 4 wks prior to the screening test and the final test. 23.Those ineligible due to physician's judgment.

Related Information

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