UMIN-CTR Clinical Trial

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
Email	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
Email	a-nagatomo@jintan.co.jp

Sponsor
Institute	Morishita Jintan Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048337