UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The decreasing effect of rose hip-derived tiliroside on the abdominal visceral fat - A systematic review
Title of the study (Brief title)	A systematic review of rose hip-derived tiliroside
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 decreasing effect of rose hip-derived tiliroside on the abdominal visceral fat.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Abdominal visceral fat area
Key secondary outcomes	Abdominal Subcutaneous fat area Abdominal Total fat area Body Mass Index (BMI)

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: 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. Proceedings and unpublished studies will be excluded. 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 will be excluded.
Target sample size	1

Research contact person
Name of lead principal investigator	Hirosato Kawakami
Organization	Morishita Jintan Co., Ltd.
Division name	Health Care Product Department
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	Akifumi Nagatomo
Organization	Morishita Jintan Co., Ltd.
Division name	Health Care Product Department
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	Morishita Jintan Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Review team Dr. Yukimasa Tanaka, Health Care Product Department, Morishita Jintan Co., Ltd. Mr. Akifumi Nagatomo, Health Care Product Department, Morishita Jintan Co., Ltd. Ms. Ai Matsumoto, Health Care Product Department, Morishita Jintan Co., Ltd. Ms. Yuki Yoshimoto, Health Care Product Department, Morishita Jintan Co., Ltd. Ms. Maho Oguri, 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)

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	2017 Year 12 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 08 Day
Anticipated trial start date	2017 Year 12 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 02 Month 09 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	(Search) AN will search 9 databases for studies from the beginning of each database to the search date. AN and AM 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., YY, MO) 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., YY, MO) 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., YT, HK). In addition, AN 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, subjects will be divided to healthy subjects and patients based on the criteria. A subgroup analysis will be performed using only healthy subjects. 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	2017 Year 12 Month 18 Day
Last modified on	2018 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034757