Male/female adults
Conditions
Interventions
Consumption of the test food (one bottle and one sachet a day) for 24 weeks
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Male/female subjects aged 50 years or older at informed consent. (2) Subjects with self-perceived physical decline. (3) Subjects who can give informed consent to participate in this research, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: Subjects- (1) engaged in heavy lifting or other physically demanding work (2) with irregular working hours, such as day-night shift (3) who have suffered injuries affecting physical mobility, such as fractures or tendon ruptures, within the past year (4) who take regularly the FOSHU, Foods with functional claims (e.g., containing lactic acid bacteria, claiming to reduce fatigue and improve cognitive function) and health food which might affect the test results (5) who take supplements containing Ca, vitamin D, amino acids, or unsaturated fatty acids (DHA/EPA) regularly within the past 6 months and unable to discontinue (6) who take drugs and quasi-drugs (e.g., nutritional supplements for fatigue, vitality, dementia medications, lactic acid bacteria preparations, gastrointestinal medications, antibiotics) and unable to discontinue (7) who take steroids or hormone (e.g., compounds containing androgen or estrogen) within the last 6 months and unable to discontinue (8) with walking impairment in daily life, such as using cane (9) who take excessive alcohol (10) who have previous/current medical history of severe cardiac, hepatic, renal, digestive, rheumatoid arthritis and osteoarthritis (11) pregnant, possibly pregnant, or lactating (12) having drug and/or food allergy (13) with self-reported lactose intolerance (14) who are now under another clinical test with some kind of medicine and/or health food, or took part in that within four weeks before this research, or will participate in that after giving informed consent to take part in this research (15) donated blood or component (0.2 L) within the last 1 months (16) donated his blood (0.4 L) within the last 3 months (17) donated her blood (0.4 L) within the last 4 months (18) being collected in total of his blood (1.2 L) within the last 12 months and in this research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frailty indicators (grip strength, gait speed, body weight) | — |
Secondary
| Measure | Time frame |
|---|---|
| Muscle mass (trunk, right arm + left arm, right leg + left leg), skeletal muscle index, bone mineral density, 6-minute walk test, chair stand up test, knee extension strength, fatigue VAS, blood biochemical tests, cognitive function, gut microbiota by 16S rRNA gene amplicon sequencing, stool and blood short-chain fatty acid analysis, urine and saliva and blood proteome analysis, intraocular pressure, olfaction, acceleration plethysmography, grip strength, 4-meter walking speed, body weight, BMI | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Clinical Planning Department
Outcome results
None listed