None listed
Conditions
Interventions
12-week consumption of the test food Exercise at the gym and home
12-week consumption of the placebo food Exercise at the gym and home
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy Japanese males and females aged 40 to 74 years-old. 2) Subjects who do not exercise regularly and are aware of declines in muscle strength than before. 3) Subjects whose BMI are under 30. 4) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Exclusion criteria
Exclusion criteria: Subjects(who) 1) regularly use drugs associated with muscle, lipid metabolism and/or amino acids preparations. 2) contract or have a history of serious diseases (eg, liver, kidney, digestive, heart, respiratory, endocrine, metabolic, skeletal muscle and/or tendon disease) 3) are undergoing or may receive surgical treatment of knee joints. 4) with a cardiac pacemaker or artificial joint, etc. 5) have had severe damage on the locomotive organs such as fracture, tendon rupture, or muscle strain in the past 1 year. 6) with physical disabilities such as severe low back pain and knee pain, which interfere with exercise. 7) are suspected to have sarcopenia as a result of screening. 8) contract or have a surgical history of digestive disease affecting digestion and absorption. 9) can't stop using supplements, and/or functional foods (including Food for Specified Health Uses, Foods with Function Claims or nutritional supplements which contain amino acids and/or proteins). 10) are prohibited from exercising by doctors. 11) declared allergic reactions to foods. 12) can't stop drinking from 2 days before each measurement. 13) have alcohol intake more than approximately 20 g/day of pure alcohol equivalent or a habit of drinking not less than 4 days a week. 14)are shift worker and/or midnight-shift worker. 15) are under treatment for or have a history of drug addiction and/or alcoholism. 16) are judged unsuitable as a subject by the investigator based on clinical testing during screening. 17) have donated over 200 mL of blood and/or blood components within the last one month prior to the consent or over 400 mL of blood and/or blood components within the last three months prior to the consent. 18) are pregnant or planning to become pregnant or breastfeed during the study period. 19) are participating in or willing to participate in other clinical studies. 20) are judged unsuitable as a subject by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Muscle mass after 12 weeks of intake | — |
Secondary
| Measure | Time frame |
|---|---|
| Muscle strength after 12 weeks of intake VAS questionnaire results after 12 weeks of intake | — |
Countries
Japan
Contacts
Public ContactYoshika Komori
KSO Corporation Clinical Trial Management department
Outcome results
None listed