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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043824
Receipt No. R000050012
Scientific Title 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-
Date of disclosure of the study information 2021/04/02
Last modified on 2021/04/02

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Basic information
Public title 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-
Acronym A Study on the Effect of Food Containing Plant Extract and Exercise on Physical Fitness and QOL
Scientific Title 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-
Scientific Title:Acronym A Study on the Effect of Food Containing Plant Extract and Exercise on Physical Fitness and QOL
Region
Japan

Condition
Condition No
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the effect of food containing plant extract on physical fitness and QOL
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Gait function
Key secondary outcomes Other indexes of physical fitness
Questionnaire

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Foods containing plant extract, 8 weeks consumption
Exercise at home (Participation in the exercise class 4 times)
Interventions/Control_2 Foods not containing plant extract, 8 weeks consumption
Exercise at home (Participation in the exercise class 4 times)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
50 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1)Males and females aged 50 to 69 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.
Key exclusion criteria 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.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Naoya
Middle name
Last name Sekiguchi
Organization Urayasu Sekiguchi Clinic
Division name Director
Zip code 279-0004
Address 5-17-27 Nekozane, Urayasu-shi, Chiba
TEL 047-306-3557
Email scfira@royal.ocn.ne.jp

Public contact
Name of contact person
1st name Yoshika
Middle name
Last name Komori
Organization KSO Corporation
Division name Sales department
Zip code 105-0023
Address 1-9-7 Shibaura, Minato-ku, Tokyo
TEL 03-3452-7733
Homepage URL
Email eigyou27@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization TOYO SHINYAKU Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical Committee of Kobuna Orthopedics Clinic
Address 5-656-17 Joto-machi, Maebashi-shi, Gunma
Tel 027-212-5608
Email sagawa@mc-connect.co.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 04 Month 02 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2021 Year 03 Month 24 Day
Date of IRB
2021 Year 04 Month 01 Day
Anticipated trial start date
2021 Year 04 Month 04 Day
Last follow-up date
2021 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 04 Month 02 Day
Last modified on
2021 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050012

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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