UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042339 |
|---|---|
| Receipt number | R000048337 |
| Scientific Title | The lowering effect of rose hip-derived tiliroside on the body mass index (BMI) - A systematic review |
| Date of disclosure of the study information | 2020/11/05 |
| Last modified on | 2021/07/16 11:25:46 |
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Basic information
Public title
The lowering effect of rose hip-derived tiliroside on the body mass index (BMI) - A systematic review
Acronym
The lowering effect of rose hip-derived tiliroside on the body mass index (BMI) - A systematic review
Scientific Title
The lowering effect of rose hip-derived tiliroside on the body mass index (BMI) - A systematic review
Scientific Title:Acronym
The lowering effect of rose hip-derived tiliroside on the body mass index (BMI) - A systematic review
Region
| Japan |
Condition
Condition
Healthy adult volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this review is to evaluate the lowering effect of rose hip-derived tiliroside on the body mass index (BMI).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Body mass index (BMI)
Body fat (abdominal total fat area, abdominal subcutaneous fat area, abdominal 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(PICOS)
Participant:
Healthy adults. Minors, pregnant women, and lactating women will be excluded.
Intervention:
Ingestion of food containing more than 0.1 mg of rose hip-derived tiliroside.
Comparison:
Ingestion of food not containing rose hip-derived tiliroside.
Outcome: BMI, Body fat (abdominal total fat area, abdominal subcutaneous fat area, abdominal visceral fat area)
Study design:
Randomized parallel-group controlled trials, randomized crossover trials, quasi randomized controlled trials, and non-randomized controlled trials will be included. Eligibility is not restricted by language. The scientific papers and reports which give us enough research details will be included.
Key exclusion criteria
The literature which does not meet the key inclusion criteria, proceedings, and unpublished studies will be excluded.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Hirosato |
| Middle name | |
| Last name | Kawakami |
Organization
Morishita Jintan Co., Ltd.
Division name
Health Care Product Department
Zip code
573-0128
Address
11-1, Tsudayamate 2-Chome, Hirakata City, Osaka
TEL
072-800-1044
h-kawakami@jintan.co.jp
Public contact
Name of contact person
| 1st name | Akifumi |
| Middle name | |
| Last name | Nagatomo |
Organization
Morishita Jintan Co., Ltd.
Division name
Health Care Product Department
Zip code
573-0128
Address
11-1, Tsudayamate 2-Chome, Hirakata City, Osaka
TEL
072-800-1044
Homepage URL
a-nagatomo@jintan.co.jp
Sponsor or person
Institute
Morishita Jintan Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Review team
Dr. Mamiko Kohno, Health Care Product Department, Morishita Jintan Co., Ltd.
Mr. Tadashi Kanaya, Health Care Product Department, Morishita Jintan Co., Ltd.
Mr. Akifumi Nagatomo, Health Care Product Department, Morishita Jintan Co., Ltd.
Ms. Kumiko Nakamura, Health Care Product Department, Morishita Jintan Co., Ltd.
Mr. Tomohiko Yamashita, Health Care Product Department, Morishita Jintan Co., Ltd.
Research collaborator
Professor Hiroharu Kamioka, Faculty of Regional Environment Science, Tokyo University of Agriculture
Name of secondary funder(s)
IRB Contact (For public release)
Organization
None
Address
None
Tel
None
None
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
| 2020 | Year | 11 | Month | 05 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Search)
AN will search 9 databases for studies from the beginning of each database to the search date.
TK and AN will search journals which are possessed in Morishita Jintan Co., Ltd.
(Data extraction)
In order to make the final selection of studies for the review, two authors (e.g., TK, AN) will independently apply all criteria to the full text of articles that have passed the first eligibility screening.
(Risk of bias assessment)
In order to ensure that variation is not caused by systematic errors in the study or execution, two authors (e.g., KN, TY) will independently assess the quality of articles. A full quality appraisal of these papers will be made using modified check list (12 items) of Cochrane Handbook for interventional trials.
Disagreement and uncertainties will be resolved by discussion with other authors (e.g., MK, HK). In addition, KN will calculate agreement rate and kappa coefficient.
(Imprecision assessment)
Imprecision assessment will be performed based on total number of participants in all included studies.
(Inconsistency evaluation)
Inconsistency evaluation will be performed according to the value of I2 and by a statistical test for heterogeneity of effect estimates in a meta-analysis.
(Meta-analysis)
Only when no heterogeneity will be found in multiple randomized controlled trials, AN will be performed a meta-analysis using RevMan 5.
(Additional analysis)
If there is an accepted diagnostic criteria about diseases related to outcome, participants will be divided to healthy participants and patients based on the criteria. A subgroup analysis will be performed using only healthy participants. In addition, meta-analysis will be performed using only randomized parallel-group trials. If there are any trials include extremely large sample size, a sensitivity study will be performed excluding the trial(s).
Management information
Registered date
| 2020 | Year | 11 | Month | 04 | Day |
Last modified on
| 2021 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048337
