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A randomized, double-blind, placebo-controlled, parallel-group, exploratory study of the effects of probiotic intake on various health indicators

A randomized, double-blind, placebo-controlled, parallel-group, exploratory study of the effects of probiotic intake on various health indicators - A randomized, double-blind, placebo-controlled, parallel-group, exploratory study of the effects of probiotic intake on various health indicators

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058391
Enrollment
96
Registered
2025-07-07
Start date
2025-09-16
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Oral intake of the test food (1 stick per day
12 weeks). Oral intake of the control food (1 stick per day
12 weeks).

Sponsors

TES Holdings Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Individuals who are between 50 and 75 years of age at the time of obtaining consent to participate in the study. 2) Individuals who wear a pedometer on a daily basis and are able to measure the number of steps taken. 3) Individuals who have been fully informed of the purpose and content of the study, have the capacity to consent, and have voluntarily volunteered to participate in the study based on a thorough understanding of the purpose and content of the study, and who have agreed to participate in the study in writing. 4) Individuals who are able to come to the hospital on the designated examination date and undergo the examination.

Exclusion criteria

Exclusion criteria: Individuals 1) undergoing treatment for chronic diseases, etc. 2) suffering from or with a history of serious diseases such as malignant tumors, respiratory diseases, liver, kidney, heart, lung, digestive and metabolic systems 3) suffering from or with a history of intestinal diseases. 4) who suffer from or have a history of sleep disorders, psychiatric disorders, drug dependence, or alcohol dependence. 5) with severe anemia. 6) with drug or food allergies or a history of allergies. 7) who regularly use medicines, including laxatives, bowel movements or laxatives. 8) who have taken antibiotics for more than one week within three months. 9)who cannot discontinue food for specified health use, food with functional claims, food with nutrient function claims, supplements, and beverages or foods containing bifidobacteria, lactic acid bacteria, or oligosaccharides during the study period. 10)who have a smoking habit. 11) who consume excessive amounts of alcohol (average of more than 40g/day of pure alcohol per week) and individuals who are unable to abstain from alcohol during the 7days prior to testing. 12) Premenopausal or postmenopausal women within 3years of menopause. 13) Women whose FSH level is less than 40mIU/ml or estradiol level is greater than 20pg/ml. 14)with a Body Mass Index (BMI) of 30kg/m2 or more. 15)with excessive exercise habits. 16) who may change their lifestyle during the study period. 17) who have had blood drawn or donated more than 200mL within 1month of the screening test or 400mL within 3months. 18) who have participated in other drug or food trials within the past month, or who are willing to participate in these trials. 19) who are judged by the investigator to be unsuitable as subjects based on the results of the subject's background, physical examination, physical examination, and clinical examination.

Design outcomes

Primary

MeasureTime frame
[Efficacy] 1)Blood health indicators 2)Gut environment 3)Urine health indicators 4)NK cell activity 5)Body composition 6)Bone density 7)AGEs score 8)Face age 9)Survey Surveys 10)Frequency of defecation, stool characteristics [Safety] Adverse events and side effects

Countries

Japan

Contacts

Public ContactRyoma Shimizu

TES Holdings Co., Ltd. Administrative Department of Clinical Trials

r.shimizu@tes-h.co.jp+81-3-6801-8480

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026