UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056664 |
|---|---|
| Receipt number | R000064700 |
| Scientific Title | Effects on body composition of the combination of continuous intake of plant-derived polyphenols and physical exercise: a randomized, placebo-controlled, double-blinded study |
| Date of disclosure of the study information | 2025/01/16 |
| Last modified on | 2025/01/08 15:49:29 |
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Basic information
Public title
Effects on body composition of the combination of continuous intake of plant-derived polyphenols and physical exercise: a randomized, placebo-controlled, double-blinded study
Acronym
Effects on body composition of the combination of continuous intake of plant-derived polyphenols and physical exercise: a randomized, placebo-controlled, double-blinded study
Scientific Title
Effects on body composition of the combination of continuous intake of plant-derived polyphenols and physical exercise: a randomized, placebo-controlled, double-blinded study
Scientific Title:Acronym
Effects on body composition of the combination of continuous intake of plant-derived polyphenols and physical exercise: a randomized, placebo-controlled, double-blinded study
Region
| Japan |
Condition
Condition
Nothing
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of combination of plant-derived polyphenol intake and physical training on body composition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total body muscle mass
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of plant-derived polyphenol and physical training
Interventions/Control_2
Intake of placebo capsule and physical training
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Individuals aged 40 to 74 years at the time of informed consent
(2) Who can participate in measurement sessions
(3) Body Mass Index (BMI) of 25.0 kg/m2 or higher
(4) Who can engage in continuous physical exercise (strength training, walking, etc.)
(5) Those who can understand the purpose and the contents of this study, and can agree with participation by letter.
Key exclusion criteria
(1) The presence of allergic response to test foods.
(2) Medication for hyper-lipidemia
(3) Taking visceral fat-reducing drugs
(4) Engaging in high-intensity exercise, such as resistance training, 3 days or more per week
(5) Participated in other clinical trials within three months
(6) Who are deemed ineligible to participate based on baseline blood test
(7) Pregnancy or beast-feeding.
(8) In addition, those who were judged inadequate by the principal investigator.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Tetsu |
| Middle name | |
| Last name | Kinoshita |
Organization
Institute of Community Life Sciences Co., Ltd
Division name
Institute of Social Epidemiology
Zip code
791-0243
Address
Hiraimachi 1383-2, Matsuyama, Ehime
TEL
089-904-7811
tetsu.prospective@gmail.com
Public contact
Name of contact person
| 1st name | Tetsu |
| Middle name | |
| Last name | Kinoshita |
Organization
Institute of Community Life Sciences Co., Ltd
Division name
Institute of Social Epidemiology
Zip code
791--0243
Address
Hiramimachi 1383-2, Matsuyama, Ehime
TEL
0899047811
Homepage URL
tetsu.prospective@gmail.com
Sponsor or person
Institute
Institute of Community Life Sciences Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Daicel Corporation
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
Institutional Review Board (IRB) of Ehime University Hospital
Address
Shitsukawa, Toon, Ehime
Tel
089-960-5172
rinri@m.ehime-u.ac.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
| 2025 | Year | 01 | Month | 16 | 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
| 2024 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 08 | Day |
Last modified on
| 2025 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064700
