UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052752 |
|---|---|
| Receipt number | R000059139 |
| Scientific Title | Effect of tea catechins on visceral fat accumulation in healthy adults: a systematic review and meta-analysis |
| Date of disclosure of the study information | 2023/11/10 |
| Last modified on | 2023/11/10 05:32:56 |
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Basic information
Public title
Effect of tea catechins on visceral fat accumulation in healthy adults: a systematic review and meta-analysis
Acronym
Effect of tea catechins on visceral fat.
Scientific Title
Effect of tea catechins on visceral fat accumulation in healthy adults: a systematic review and meta-analysis
Scientific Title:Acronym
Effect of tea catechins on visceral fat.
Region
| Japan |
Condition
Condition
visceral fat accumulation
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This systematic review and meta-analysis was to assess the overall effect of tea catechin supplementation on visceral fat accumulation in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
visceral fat area
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants: healthy adults
Intervention: Tea catechin
Comparison: Placebo and/or Control
Outcome :abdominal visceral fat area
Study design: Controlled trial and prospective cohort study
Key exclusion criteria
Patients
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Kazuya |
| Middle name | |
| Last name | Kozuma |
Organization
Kao corporation
Division name
Health and wellness product reseach
Zip code
131-8501
Address
2-1-3, Bunk, Sumida-ku, Tokyo
TEL
+81-3-5630-7476
kouzuma.kazuya@kao.com
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Kozuma |
Organization
Kao corporation
Division name
Health and wellness product reseach
Zip code
131-8501
Address
2-1-3, Bunk, Sumida-ku, Tokyo
TEL
+81-3-5630-7476
Homepage URL
kouzuma.kazuya@kao.com
Sponsor or person
Institute
Kao corporation
Institute
Department
Personal name
Funding Source
Organization
Kao corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Otsuma women's university
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Not applicable
Address
Not applicable
Tel
Not applicable
Not applicable
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
| 2023 | Year | 11 | Month | 10 | 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
| 2023 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design
Systematic review and meta-analyses of randomized controlled trials and observational studies.
Data sources
Medline (PubMed), JDream III and University hospital Medical Information Network Clinical Trials Registry (UMIN-CTR)
Eligibility criteria for selecting studies
Controlled trials and prospective cohort studies.
Data extraction and synthesis
Risk of bias:(Revised tool to assess risk of bias in randomized trials (RoB 2.0), and Newcastle-Ottawa scale (NOS) for cohort studies).
Meta-analyses:ean difference (MD) for VFA.
random effects models with restricted maximum likelihood estimator.
Certainty of evidence: Grading of Recommendations Assessment, Development and Evaluation (GRADE) .
Management information
Registered date
| 2023 | Year | 11 | Month | 10 | Day |
Last modified on
| 2023 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059139
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
