A Study on the Effect of Food Containing Plant Extract and Exercise on Physical Fitness and QOL -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
- Conditions
- o
- Registration Number
- JPRN-UMIN000043824
- Lead Sponsor
- KSO Corporation
- Brief Summary
Statistically significant difference was confirmed in the primary outcome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
Subjects (who) 1)regularly use drugs associated with muscle and/or lipid metabolism. 2)cannot stop using supplements, and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) during the test periods. 3)contract serious diseases that require urgent treatment, or serious complications. 4)contract or have a history of serious diseases(eg, liver disease, kidney diseases, digestive disease, heart disease, respiratory disease, endocrine disease, metabolic disease, skeletal muscle disease and/or tendon disease). 5)contract or have a surgical history of digestive disease affecting digestion and absorption. 6)who are undergoing or may receive surgical treatment of knee joints. 7)with pacemaker or artificial joint, etc. 8)have had severe damage on the locomotive organs such as fracture, tendon rupture, or muscle strain in the past 1 year. 9)with physical disabilities such as severe low back pain and knee pain, which interfere with exercise. 10)whose exercise is prohibited by doctors. 11)declared allergic reactions to foods. 12)with a history of and/or current drug addiction and/or alcoholism. 13)were judged as unsuitable for the current study by screening tests. 14)are participating in or willing to participate in other clinical studies. 15) were judged as unsuitable for the current study by the investigator for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gait function
- Secondary Outcome Measures
Name Time Method Other indexes of physical fitness Questionnaire