UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060257 |
|---|---|
| Receipt number | R000068921 |
| Scientific Title | Effect of Ingestion of Polyphenol on Body Composition: An Exploratory Study |
| Date of disclosure of the study information | 2026/01/14 |
| Last modified on | 2026/01/05 11:12:02 |
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Basic information
Public title
Effect of Ingestion of Polyphenol on Body Composition: An Exploratory Study
Acronym
Effect of Ingestion of Polyphenol on Body Composition: An Exploratory Study
Scientific Title
Effect of Ingestion of Polyphenol on Body Composition: An Exploratory Study
Scientific Title:Acronym
Effect of Ingestion of Polyphenol on Body Composition: An Exploratory Study
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of 8 weeks ingestion of polyphenol on body composition in a randomized, double-blind, placebo-controlled, parallel group study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body composition (body weight, body fat rate, body fat mass, muscle mass, lean body mass, skeletal muscle mass, SMI, ECW/TBW) at 8 weeks after ingestion.
Key secondary outcomes
Body mass index, waist circumference, blood glucose
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consume the test food once a day for 8 weeks.
Interventions/Control_2
Consume the placebo food once a day for 8 weeks.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Those who agree to participate in this study with a written informed consent.
2.Those with BMI is >=23 kg/m2 and <30 kg/m2 at the time of screening.
Key exclusion criteria
1.Those who are continuously using oral, injectable, or other systemic medications for the treatment of chronic diseases.
2.Those who are under medical supervision for exercise therapy or dietary therapy.
3.Those with HbA1c levels of 6.5% or more at the time of screening.
4.Those who use implantable metallic medical devices.
5.Those with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal, respiratory diseases, and/or affected with infectious diseases requiring official reports.
6.Those with major surgical history related to the digestive system.
7.Those with seriously abnormal blood pressure, physical data or hematologic data.
8.Those with severe anemia.
9.Pre- or post-menopausal women with obvious physical changes.
10.Those who may have allergic reactions to drugs, foods.
11.Those with high sensitivity to caffeine.
12.Those who regularly use medications, dietary supplements, foods for specified health uses, or foods with function claims that affect body weight or body fat.
13.Those who frequently take polyphenol-rich foods.
14.Heavy smokers, alcohol addicts or subjects with disordered lifestyle.
15.Those who are unable to stop taking dietary supplements and foods with health claims during the study.
16.Those whose lifestyle is planned to change during the study.
17.Those who plan to transfer, or take a business trip or travel for one week or longer during the study.
18.Those who changes in body weight of 10% or more within 12 wks prior to the screening.
19.Those who donated either 400 ml whole blood within 16 wks (women), 12 wks (men), 200 ml whole blood within 4 wks (men and women), or blood components within 2 wks (men and women), prior to the screening.
20.Pregnant or lactating women or those planning to become pregnant.
21.Those who currently participate in other clinical trials or participated within the last 4 wks prior to the current study.
22.Those ineligible due to physician's judgment.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | HONMA |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
hisc-acad.res@s.do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | HONMA |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
Homepage URL
hisc-acad.res@s.do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Hokkaido Information University
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel
011-385-4411
soumu@do-johodai.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
北海道情報大学 保健センター（北海道）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 14 | 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
| 2025 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 05 | Day |
Last modified on
| 2026 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068921
