Effect of Food Containing Plant Extract and Exercise on Physical Fitness and QOL -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study

Not Applicable

• Conditions: o

• Registration Number: JPRN-UMIN000052680
• Lead Sponsor: KSO Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-02
• Last Update Posted: 20 November 2023
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Subjects (who) 1)regularly use drugs associated with muscle and/or lipid metabolism 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 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) have a probability of idiopathic chronic fatigue or chronic fatigue syndrome based on self-report 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 or Foods with Function Claims) 10)whose exercise is prohibited 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 shiftworker and/or midnight-shift worker 15)with a history of and/or current drug addiction and/or alcoholism 16)were judged as unsuitable for the current study by screening tests 17) have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study 18) are pregnant or planning to become pregnant or breastfeed 19)are participating in or willing to participate in other clinical studies 20)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
indexes of physical fitness

Secondary Outcome Measures

Name	Time	Method
Questionnaire