Elderly male/female subjects
Conditions
Interventions
Oral ingestion of the test food-1 with water/lukewarm (200 mL) to the subjects, 2 packages a day for 12 weeks.
Oral ingestion of the test food-2 with water/lukewarm (200 mL) to the subjects, 2 package
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Male/female subjects 65 and above at consent. (2) Subjects who have no difficulty in carrying out the designated exercise twice a week. (3) Subjects who can give consent forms to join this test after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: (1) Subjects who will take steadily in the medicines (muscle-enhancing/anti-inflammation (over twice a week)/growth hormone/anti-dementia/anti-choline/sleeping pill/anti-fear/anti-depression/anti-mental disease/SGLT2-inhibitory/anti-Shenkui), which might affect the test results. (2) Subjects who have a habit of exercises, except taking a walk. (3) Subjects who have any difficulty in refraining from taking steadily (over once a week) in the health-specific/functional/supplementary/health foods, including amino acids and/or proteins, which might reveal some kind of effect for maintaining their muscle and muscular strength, and inhibiting a failure of those. (4) Subjects who are given a massage/chiropractic steadily (over once a week) and/or will be given those, which might affect the test results during test period. (5) Subjects with previous/present medical history of serious diseases in heart, liver, kidney and/or digestive organs. (6) Subjects who excessively take alcohol. (7) Subjects with extremely irregular eating habits and life rhythms, midnight work and/or irregular shift one. (8) Subjects with wheat allergy. (9) Subjects who are now under the other clinical test with a medicine/food, or took part in that within 4 weeks before this test, or will join that after giving informed consent to join this test. (10) Subjects who donated over 200 mL of their whole blood and/or blood components within a month before this test. (11) Males who donated over 400 mL of their whole blood within the last 3 months before this test. (12) Females who donated over 400 mL of their whole blood within the last 4 months before this test. (13) Males who will be collected over 1200 mL in total of their blood within 12 months, before and in this test. (14) Females who will be collected over 800 mL in total of their blood within 12 months, before and in this test. (15) Others who have been determined as ineligible for entry, according to the principal/sub investigator's opinions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Short physical performance battery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Grip strength 2. Leg muscle strength 3. Walking test for 6 min 4. Soft lean mass 5. Body fat mass 6. Muscle mass balance (right/left arm, body trunk, right/left leg) 7. Short version of POMS2 8. Changes in clinical test values | — |
Countries
Japan
Contacts
Public ContactMakoto Ichinohe
CPCC Company Limited Clinical Planning Department
Outcome results
None listed