None
Conditions
Interventions
Intake of test foods for 12 weeks
No intake of test foods for 12 weeks
Sponsors
KSO corporation
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Healthy women who are between 60 and 74 years of age at the time of the preliminary survey/inspection. (2) BMI ranging from 17 to < 30. (3) Persons who have been sufficiently 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 have given their consent to participate in the study in writing. (4) Persons who are able to intake the test foods continuously from the begining to the end of the study.
Exclusion criteria
Exclusion criteria: (1) Persons who are on continuous dietary guidance, diet therapy, or medication that may affect this study for the treatment of disease, etc. (2) Persons who suffer from or have a history of psychiatric disorders or serious gynecological disorders. (3) Persons with severe menopausal symptoms. (4) Persons who have an extremely irregular diet, drink excessive amounts of alcohol on a daily basis, work in shifts, or work late at night. (5) Persons with a history or current medical history of drug dependence or alcohol dependence. (6) Persons who are participating, intend to participate, or have participated within the past 3 months in tests of other foods, tests involving the use of drugs, or tests involving the application of cosmetics, drugs, etc. (7) Persons who are scheduled to travel abroad or on a long business trip and cannot intake the test foods for the duration of the study. (8) Persons who take nutritional supplements or dietary supplements on a daily basis that may affect the results of the study. (9) Persons who are suspected to have cognitive impairment. (10) Persons with sleep disorders. (11) Persons with a history of drug allergy or food allergy. (12) Persons who have reported lactose intolerance. (13) Patients with implanted medical devices such as pacemakers. (14) Persons with an excessive smoking habit (21 or more cigarettes per day). (15) Persons who had more than 400 mL of blood drawn within 12 weeks prior to the start of intake, or more than 200 mL of blood drawn during the previous observation period. (16) Any subject who is judged to be unsuitable as a subject by the investigator or subinvestigator based on the results of the subject's background, physical findings, physical examination, and clinical examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Health Related Quality of Life (SF-36v2 (standard version)) | — |
Secondary
| Measure | Time frame |
|---|---|
| Energy and nutrient intake | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Clinical Trial Management department
Outcome results
None listed