Healthy subjects
Conditions
Interventions
Continuous intake of the placebo foods for 12 weeks.
Continuous intake of the test foods A for 12 weeks.
Continuous intake of the test foods B for 12 weeks.
Continuous intake of the test foods C for 1
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese men and women aged between 60 and 75 years old at the time of obtaining written consent. 2.Subject with BMI >=19kg/m2 and <24kg/m2. 3.Subject who is exercise or walking less than once a week and for less than 30 minutes each time. 4.Subject who does not provide childcare or nursing care on a daily basis (more than 4 hours per week). 5.Subject who has received sufficient explanation of the purpose and content of the research, has the ability to consent.
Exclusion criteria
Exclusion criteria: 1.Subject who has been instructed by a doctor to refrain from walking or exercise. 2.Subject who is taking medication or under medical treatment due to serious illness. 3.Subject who is under exercise therapy or dietetic therapy. 4.Subject who may develop allergies by raw materials for test foods (soybeans, shrimp, crab, wheat, milk, eggs, almonds, squid, oranges, cashew nuts, kiwifruit, beef, sesame, salmon, mackerel, chicken, bananas, pork, peaches, Japanese yam, apples, gelatin). 5.Subject with current or history of drug or alcohol dependence. 6.Subject who attends a hospital due to mental disorders (depression, etc.) or sleep disorders (Insomnia, sleep apnea syndrome, etc.), or who has a history of mental illness in the past. 7.Subject who is current smokers or those who have had a smoking habit for the past 3 months. 8.Subject whose working hours are irregular due to night shifts, etc. 9.Subject who has extremely irregular lifestyle habits such as eating and sleeping. 10.Subject who has an extremely unbalanced diet. 11.Subject who had a weight fluctuation of +- 5 kg or more within 3 months. 12.Subject with knee surgery or disease, or those who use a cane on a daily basis. 13.Subject with serious current or history of brain disease, malignant tumor, immune disease, diabetes, renal disease, heart disease, thyroid disease, adrenal disease, and other metabolic diseases. 14.Subject who has used and are still using supplements or medications that affect muscle strength/muscle, gait function, or fatigue reduction within the past 3 months. 15.Subject who has consumed and are currently consuming healthy oils (coconut oil, MCT oil, etc.) that may have enhanced the dietary components being evaluated dating back to the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee extension muscle strength test, Grip strength test, timed up & go test. | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) Health-related quality of life, body composition, balance function and plantar pressure. (Safety evaluation) Vital signs, physical measurements (weight, BMI), adverse events. | — |
Countries
Japan
Contacts
Public ContactHidemasa Toya
HUMA R&D CORP Clinical Development Department
Outcome results
None listed