UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057837 |
|---|---|
| Receipt number | R000066114 |
| Scientific Title | A systematic review of the effects of oral oenothein B intake on visceral fat, body weight, and body mass index (BMI)/ updated version |
| Date of disclosure of the study information | 2025/05/12 |
| Last modified on | 2025/05/12 12:29:13 |
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Basic information
Public title
A systematic review of the effects of oral oenothein B intake on visceral fat, body weight, and body mass index (BMI)/ updated version
Acronym
A systematic review of oenothein B/ updated version
Scientific Title
A systematic review of the effects of oral oenothein B intake on visceral fat, body weight, and body mass index (BMI)/ updated version
Scientific Title:Acronym
A systematic review of oenothein B/ updated version
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to examine the effects of oral oenothein B intake on visceral fat, body weight, and BMI.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visceral fat area
Body weight
BMI
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants (P): Healthy adults (excluding pregnant and lactating women) with a BMI of 23 or higher and less than 30, who do not fall outside the scope of subjects eligible for Food for Specified Health Uses.
Intervention (I): Oral intake of test food containing oenothein B.
Comparison (C): Intake of placebo (control) food not containing oenothein B.
Outcomes (O): Reduction in visceral fat, body weight, and BMI.
Study Design (S): Randomized double-blind placebo-controlled trial (RCT) with parallel-group comparison or crossover comparison.
Publication format: Peer-reviewed original articles, systematic reviews, or meta-analysis reports only. However, results published in clinical trial registration databases are included. Unpeer-reviewed reports are limited to those with detailed content, such as doctoral theses or reports similar to statistical white papers issued by public institutions.
Key exclusion criteria
Reports that are not clinical trials involving humans.
Reports that do not meet the above PICOS criteria.
Reports that do not meet the above report characteristics.
Reports without a control group.
Reports that did not evaluate the efficacy of oenothein B alone.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Ochi |
Organization
Nagaoka Co., Ltd.
Division name
Research and Development Center
Zip code
567-0005
Address
1-3-30, Itsukaichi, Ibaraki, Osaka, JAPAN
TEL
072-623-5252
mail@npc-nagaoka.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Office |
Organization
Nagaoka Co., Ltd.
Division name
Research and Development Center
Zip code
567-0005
Address
1-3-30, Itsukaichi, Ibaraki, Osaka, JAPAN
TEL
072-623-5252
Homepage URL
mail@npc-nagaoka.co.jp
Sponsor or person
Institute
Nagaoka Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nagaoka Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Evaluation Center of Health and Nutrition Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
-
-
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 | 05 | Month | 12 | 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 | 01 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Searches]
The search strategy is developed by reviewer A in consultation with reviewer B under the guidance of reviewer C, who is experienced in conducting clinical and epidemiological research. Finally, it will be agreed upon by all three reviewers. Reviewer A conduct searches using medical literature databases and clinical trial registries, and also perform hand searches. The search period covers all studies published up to the search date.
[Studies extraction]
Reviewers A and B independently select studies. The result will be decided through discussion. If the two reviewers disagree, three reviewers, including reviewer C, will discuss and make a decision.
Reviewers A and B independently extract data from each study and summarize them by outcome.
If data in the selected studies are unclear, they will contact the corresponding author.
[Risk of bias assessment]
The validity and reliability of each study is evaluated independently by reviewers A and B, based on the reference materials. The evaluation items are risk of bias, indirectness, imprecision, inconsistency, and others (publication bias, etc.). If the two reviewers disagree, they will discuss and reviewer C will arbitrate. The degree of matching and the Kappa coefficient will be calculated.
[Meta-analysis]
Reviewers will conduct a meta-analysis (quantitative SR) using R software when two or more studies are selected, there is high PICO item similarity and no heterogeneity in the research designs. If there is missing data, the values will be obtained by contacting the corresponding author.
[Certainty assessment]
Regarding the certainty of the evidence, risk of bias, indirectness, imprecision, inconsistency, and others (publication bias, etc.) will be rated as "Low (0)", "Medium (-1)", and "High (-2)", respectively. If the sum of each item will be 0~-1, then the certainly of evidence for an outcome will be evaluated as "High", -2~-4 as "Moderate", -5~-7 as "Low", and -8 or less as "Very Low".
Management information
Registered date
| 2025 | Year | 05 | Month | 12 | Day |
Last modified on
| 2025 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066114
