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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030442
Receipt No. R000034757
Scientific Title The decreasing effect of rose hip-derived tiliroside on the abdominal visceral fat - A systematic review
Date of disclosure of the study information 2017/12/18
Last modified on 2018/12/19

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Basic information
Public title The decreasing effect of rose hip-derived tiliroside on the abdominal visceral fat - A systematic review
Acronym A systematic review of rose hip-derived tiliroside
Scientific Title The decreasing effect of rose hip-derived tiliroside on the abdominal visceral fat - A systematic review
Scientific Title:Acronym 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
1st name
Middle name
Last name Hirosato Kawakami
Organization Morishita Jintan Co., Ltd.
Division name Health Care Product Department
Zip code
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
Middle name
Last name Akifumi Nagatomo
Organization Morishita Jintan Co., Ltd.
Division name Health Care Product Department
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2017 Year 12 Month 08 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000034757

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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