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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000052680
Enrollment
60
Registered
2023-11-02
Start date
2023-11-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Foods containing plant extract, 12 weeks consumption Exercise at gym and home Foods not containing plant extract, 12 weeks consumption Exercise at gym and home

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)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 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

Design outcomes

Primary

MeasureTime frame
indexes of physical fitness

Secondary

MeasureTime frame
Questionnaire

Countries

Japan

Contacts

Public ContactYoshika Komori

KSO Corporation Clinical Trial Management department

eigyou27@kso.co.jp03-3452-7733

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026