Validation study of effects of test food ingestion on subjective symptoms and performance after exercise.
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000041441
- Lead Sponsor
- CPCC Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 20
Not provided
(1) Those who have previous and/or current medical history of serious disease. (2) Those who habitually take medicines possibly affecting the test results or who can't restrict them. (3) Those who have allergy to medicine and/or food (including allergy to collagen and gelatin). (4) Those who habitually take the following products possibly affecting the test results or those who can not restrict them: Food for Specified Health Uses, Food with Function Claim, Food with Nutrient Function Claim, health foods, dietary supplement, sport nutrition products (e.g., BCAA, Protein, Protein Bar, Protein Drink), energy drinks (e.g., Red Bull), and nutritional drink (e.g., Lipovitan D). (5) Those who have a taste for collagen-rich meals such as "motsu" and "horumon", and actively take them more than 4 times a week. (6) Those who had exercises and/or activities with muscle pain during the last one month before SCR test. (7) Those who plan to have exercises and/or activities with muscle pain during the test period. (8) Those who habitually have body-care. (9) Those who can't participate in the test on schedule. (10) Those who have smoking habit. (11) Those who take a lot of alcohol. (12) Those who have extremely irregular life style. (13) Those who are currently participating in other clinical trials of medicine or health food, or who did within 4-weeks, or who plan to do just after giving informed consent. (14) Those who donated 200 mL of whole blood and/or blood components during the last one month before starting this clinical trial. (15) Those who donated 400 mL of whole blood during the last three months before starting this clinical trial. (16) Those whose total blood collection volume exceeds 1200 mL when the amount of blood collection in the clinical trial and it during the last 12 months before the starting are summed. (17) Those who have been determined ineligible to participate in this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Visual Analogue Scale (VAS) of muscle soreness
- Secondary Outcome Measures
Name Time Method VAS of fatigue Muscle strength Range of motion In the blood levels of Myoglobin, CPK, CRP, LDH, GH and Collagen SF-8 Standard Incidence of adverse events and of side effects