Elderly male/female subjects
Conditions
Interventions
Oral ingestion of the test food before or after breakfast, 2 capsules a day.
Oral ingestion of the placebo food before or after breakfast, 2 capsules a day.
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Male/female subjects aged 65 to 75 years old when consent acquisition. (2) Subjects who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: (1) Subjects who use affecting health foods routinely (over 3 times a week), and have any difficulty in stopping use after the consent. (2) Subjects who use the affecting medicines (International Standard as the 2022 Prohibited List of World Anti-Doping Code: anabolic agents, hormonal peptides, growth factors, beta2-agonists, and hormone/metabolism regulators), over 3 times a week, and have any difficulty in limiting use during this study. (3) Subjects who have a habit of resistance exercises with over moderate, or other ones with over high intensity. (4) Subjects who drink a lot of alcohol. (5) Subjects who have been suffered severely from their motor function (e.g., fracture, tendon rupture and tone muscle) within a year before this study. (6) Subjects with an impaired motor function. (7) Subjects who use implantable medical electronic devices, such as a pacemaker. (8) Subjects being prohibited from doing exercise, by a doctor. (9) Subjects with previous/present medical history of serious diseases in heart, liver, kidney, lung, digestive organs, blood, and endocrine/nervous/metabolic systems. (10) Subjects with drug and/or food allergy. (11) Subjects who are now under another clinical study with a medicine/food, or take part in that within 4 weeks before this study, or will join that after the consent to join this study. (12) Subjects who donated over 200 mL of their whole blood and/or blood components within a month before this study. (13) Males who donated over 400 mL of their whole blood within the last 3 months before this study. (14) Females who donated over 400 mL of their whole blood within the last 4 months before this study. (15) Males who will be collected over 1200 mL in total of their blood within 12 months, before and in this study. (16) Females who will be collected over 800 mL in total of their blood within 12 months, before and in this study. (17) Subjects who have been determined as ineligible for participation, by the principal/sub investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stepping frequency (upright and sitting positions) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Choice reaction time 2. Grip strength 3. SPPB 4. Ability of standing up motion 5. Body composition 6. VAS (fatigue feeling) 7. Short version of POMS2 8. OSA sleep inventory MA version 9. Pittsburg sleep questionnaire 10. NAD-metabolites in blood 11. Capacity of hearing | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed