Healthy volunteers
Conditions
Interventions
Intake of test food for 24 weeks (once a day, 3 capsules)
Sponsors
Medical Corporation Heishinkai ToCROM Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women aged 40-55 years 2) BMI >=25.0 and <30.0 kg/m2 3) Subjects who received a full explanation of the study objectives and procedures, understood the information, voluntarily agreed to participate, and provided written informed consent
Exclusion criteria
Exclusion criteria: 1) Subjects with diabetes mellitus; receiving pharmacological treatment within the past 6 months; or with a history of renal, hepatic, cardiac, or other diseases considered unsuitable for participation. 2) Subjects regularly consuming foods, supplements, or medications that may affect the intestinal environment (e.g., probiotics, prebiotics, dietary fiber supplements, intestinal regulators, laxatives, or antibiotics). 3) Subjects with lactose intolerance or diarrhea following dairy consumption. 4) Subjects with diarrhea after alcohol consumption, except those who do not habitually consume alcohol and agree to abstain throughout the study. 5) Subjects engaged in shift work, irregular work schedules, physically demanding labor, irregular holidays, or frequent night shifts during the study period. 6) Subjects planning significant lifestyle changes during the study period. 7) Subjects smoking >=21 cigarettes/day. 8) Subjects consuming excessive alcohol (>=21 g alcohol/day). 9) Subjects consuming excessive caffeinated beverages (>=7 cups of coffee/day). 10) Subjects with self-reported food allergies. 11) Subjects who are pregnant, breastfeeding, or planning pregnancy during the study period. 12) Subjects who participated in another clinical study within 1 month before informed consent or plan to participate in another study during the study period. 13) Subjects who donated 200 mL or 400 mL whole blood, received a blood transfusion within 3 months before testing, or donated blood components within 2 weeks before testing. 14) Subjects deemed unsuitable based on screening assessments. 15) Subjects currently participating in, or intending to participate in, another study involving foods, medications, cosmetics, quasi-drugs, or pharmaceuticals. 16) Subjects otherwise judged unsuitable by the principal investigator or sub-investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of Aging-Related Indicators after continuous consumption of research food for 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| BMI,questionnaire, hematologic test, blood biochemistry test | — |
Countries
Japan
Contacts
Public ContactHisako Nakagawa
Megmilk Snow Brand Co., Ltd. Milk Science Research Institute
Outcome results
None listed