Healthy subjects
Conditions
Interventions
Daily intake of test food (dairy product) and lifestyle interventions for 12 weeks
Non-intervention
Sponsors
KSO Corporation
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Men aged 50 to 74 years. 2) Individuals who can understand the purpose and content of this study, and voluntarily wish to participate, and have provided written consent for participation in this study. 3) Individuals with a Body Mass Index of 25 or higher. 4) Individuals who do not have a habit of consuming fermented milk (up to once a week). 5) Individuals who can measure their daily step count regularly. 6) Individuals who are able to exercise regularly (those who have not been advised against exercise by a doctor).
Exclusion criteria
Exclusion criteria: 1) Individuals who have or have a history of severe diseases such as malignant tumors, gastrointestinal, and metabolic disorders. 2) Individuals who have or have a history of intestinal diseases. 3) Individuals who have or have a history of drug or food allergies. 4) Individuals who have lactose intolerance. 5) Individuals who regularly use medications including laxatives, digestive aids, or stool softeners. 6) Individuals who have taken antibiotics for more than a week within the past three months. 7) Individuals who cannot discontinue the use of Food for Specified Health Uses (FOSHU), Foods with Functional Claims, Food with Nutrient Function Claims, or beverages/foods containing bifidobacteria, lactic acid bacteria, oligosaccharides, lactoferrin, etc., during the study period. 8) Individuals who are on a diet or losing weight through exercise. 9) Individuals who have a habit of skipping meals. 10) Individuals who are under medical supervision for exercise guidance, dietary therapy, or health direction. 11) Individuals who engage in moderate to high-intensity exercise for more than 30 minutes, at least three times a week. 12) Heavy smokers (those who smoke an average of 21 or more cigarettes per day). 13) Individuals whose daily alcohol consumption exceeds an average of 60 grams of pure alcohol per day. 14) Individuals who have donated or had blood drawn exceeding 200 mL within one month or 400 mL within three months before the screening test. 15) Individuals who work night shifts, have irregular weekly rotating shifts, engage in physical labor, or have irregular lifestyle habits. 16) Individuals who may change their lifestyle habits during the study period. 17) Individuals who have participated in other drug or food trials in the past month or intend to participate in such trials. 18) Individuals who are deemed unsuitable as subjects by the principal investigator based on their background, physical examination, physical tests, and clinical examination results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight, Health outcomes (blood, stool, questionnaires) | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Clinical Trial Management department
Outcome results
None listed