UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038540
Receipt number R000043922
Scientific Title A pilot study of the effects of grape seed proanthocyanidin extract on visceral fat accumulation in women
Date of disclosure of the study information 2019/11/11
Last modified on 2019/11/11 14:28:29

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Basic information

Public title

A pilot study of the effects of grape seed proanthocyanidin extract on visceral fat accumulation in women

Acronym

A pilot study of the effects of grape seed proanthocyanidin extract on visceral fat accumulation in women

Scientific Title

A pilot study of the effects of grape seed proanthocyanidin extract on visceral fat accumulation in women

Scientific Title:Acronym

A pilot study of the effects of grape seed proanthocyanidin extract on visceral fat accumulation in women

Region

Japan


Condition

Condition

visceral adiposity

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of proanthocyanidin-rich grape seed extract on visceral fat accumulation in women

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

visceral fat area after 12 weeks of treatment

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

12-week treatment with 200 mg of proantohocyanidin

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

20 years-old <=

Age-upper limit

65 years-old >

Gender

Female

Key inclusion criteria

healthy women whose visceral fat area are larger than 100 square centimeters

Key exclusion criteria

women who are being treated with drugs or dietary supplements proven to decrease visceral fat area

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Masakazu
Middle name
Last name Terauchi

Organization

Tokyo Medical and Dental University

Division name

Department of Women's Health

Zip code

113-8510

Address

Yushima 1-5-45, Bunkyo, Tokyo

TEL

03-5803-4605

Email

teragyne@tmd.ac.jp


Public contact

Name of contact person

1st name Masakazu
Middle name
Last name Terauchi

Organization

Tokyo Medical and Dental University

Division name

Department of Women's Health

Zip code

113-8510

Address

Yushima 1-5-45, Bunkyo, Tokyo

TEL

03-5803-4605

Homepage URL


Email

teragyne@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical and Dental University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo Medical and Dental University

Address

Yushima 1-5-45, Bunkyo, Tokyo

Tel

03-3813-6111

Email

info.bec@tmd.ac.jp


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

2019 Year 11 Month 11 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

Preinitiation

Date of protocol fixation

2019 Year 11 Month 11 Day

Date of IRB


Anticipated trial start date

2020 Year 01 Month 01 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 11 Month 11 Day

Last modified on

2019 Year 11 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043922


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name