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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048337


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name