Analysis of the effect of lactic acid bacteria intake on blood anti-aging indices

UMIN ID: UMIN000056967

Registered date:09/02/2025

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: No
• Date of first enrollment: 2025/02/21
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Oral intake of the test food (1 packet per day; 4 weeks).

Outcome(s)

• Primary Outcome: Anti-aging index (Week 0, Week 4)
• Secondary Outcome: *Secondary indexes 1) Survey of subjective symptoms of aging (1) *Safety 1) Physical examination (1) 2) Clinical examination (1) 3) Doctor's questions (1) 4) Existence and its contents of side effects (2) 5) Adverse events (2) (1): Week 0, Week 4 (2): Week 4

Key inclusion & exclusion criteria

• Age minimum: 60years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: Individuals 1)using medical products. 2)with a history or current history of mental illness, sleep disorders, hypertension, diabetes, dyslipidemia or serious illness. 3) who have a history or current history of serious disorders of the liver, kidney, heart, lungs, blood, etc. 4) who are a patient or have a history of or endocrine disease. 5) who are taking medications for more than 2 days per week that may affect the study and cannot be restricted during the study period (intestinal medications, antibiotics) 6) with a BMI of 30 kg/m2 or greater. 7) with systolic blood pressure less than 90 mmHg. 8) who experienced unpleasant feeling during blood drawing. 9) with drug and food allergies. 10) who regularly use Food for Specified Health Use, Food with Functional Claims, etc. 11) who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). 12) who have a smoking habit, and individuals who have had a smoking habit within the past year. 13) Shift workers or night workers. 14) who may change their lifestyle during the study period (e.g., long trips). 15) who have donated component blood or 200 mL of whole blood in the month prior to the start of the study. 16) who donated 400 mL of whole blood 4 months prior to the start of the study. 17) whose blood volume collected in the 12 months prior to the start of the study plus the total planned blood volume for the study exceeds 800 mL. 18) who are currently participating in another human clinical trial or who have not yet completed 3 months of participation in another human clinical trial. 19) judged inappropriate for the study by the principal.

Related Information

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