None
Conditions
Interventions
Intake of one bottle of study Food A once a day for 12 weeks.
Intake of one bottle of study Food B once a day for 12 weeks.
No intake of study food.
Sponsors
KSO Corporation
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Men between 60 and 80 years of age at the time of obtaining consent. 2) Those who are aware that their physical strength has decreased compared to the past. 3) Those who are determined to be in the borderline range in the urinary VOC (frailty index) measurement performed in the screening test. 4) Those who scored 13 points or less on the designated evaluation Measures prior to the screening test. 5) Those who have received a sufficient explanation of the purpose and content of the study, have the ability to consent, voluntarily applied to participate in the study after a good understanding, and have agreed to participate in the study in writing.
Exclusion criteria
Exclusion criteria: 1) Those with serious illnesses such as cancer, liver damage, kidney damage, heart disease, diabetes, etc. 2) Those who cannot come to the research site by themselves. 3) Those who have difficulty in taking study food. 4) Those who cannot perform the walking test or one leg stand test (those who need a cane, those who have problems in normal walking, etc.). 5) Those who take health foods that may influence the research results. 6) Those who regularly use study food. 7) Those who have a digestive disease or a history of digestive surgery (except appendicitis). 8) Those who have a history or current history of alcohol dependency. 9) Those who have reported food allergies to the study foods. 10) Those who are unable to abstain from alcohol from the day before each test. 11) Those who suffer from mental illness such as depression. 12) Those who have an extremely irregular dietary habit, those who work late-night shifts (including those who work late-night hours), or those who have an irregular rhythm of life. 13) Those who have participated or wish to participate in trials involving the ingestion of other foods or the use of drugs, or the application of cosmetics and drugs, within 3 months before the date of obtaining consent. 14) Those who are judged by the principal investigator to be inappropriate as study subjects for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary metabolites | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Grip strength 2) The 6-Meter Walking Test 3) Turn up Go(Time up and go test) 4) The Eyes opened Single Leg Balance Test 5) SMI 6) The Japan Science and Technology Agency Index of Competence 7) The Zung Self-Rating Depression Scale 8) GAD-7 9) WHO-5 10) Frailty Basic Checklist | — |
Countries
Japan
Contacts
Public ContactMasanori Numazu
KSO Corporation Clinical Trial Management department
Outcome results
None listed