UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043824 |
|---|---|
| Receipt number | 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 | 2022/05/27 10:38:17 |
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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
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
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
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
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
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000050012
Publication of results
Published
Result
URL related to results and publications
http://www.pieronline.jp/content/article/0386-3603/50040/711
Number of participants that the trial has enrolled
40
Results
Statistically significant difference was confirmed in the primary outcome.
Results date posted
| 2022 | Year | 05 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Males and females aged 50 to 70years old.
Participant flow
Enrolled(n=40)
Completed(n=40)
Analysed(n=32)
Adverse events
No adverse events were observed that be related to test food.
Outcome measures
Gait function
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2022 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050012
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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