UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021970
Receipt number R000025166
Scientific Title Effect of a plant-derived processed product on visceral fat area
Date of disclosure of the study information 2016/05/10
Last modified on 2019/07/25 13:59:13

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Basic information

Public title

Effect of a plant-derived processed product on visceral fat area

Acronym

Effect of a plant-derived processed product on visceral fat area

Scientific Title

Effect of a plant-derived processed product on visceral fat area

Scientific Title:Acronym

Effect of a plant-derived processed product on visceral fat area

Region

Japan


Condition

Condition

healthy humans

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of plant-derived processed product on visceral fat area

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

visceral fat area

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

12-wk repeated consumption of control product (product code A-001), visceral fat area measurement every 4wk, pre-treatment observation period (4wk), post-treatment observation period (4wk) , dose of 1 serving per day

Interventions/Control_2

12-wk repeated consumption of test product (product code B-001), visceral fat area measurement every 4wk, pre-treatment observation period (4wk), post-treatment observation period (4wk), dose of 1 serving per day

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

35 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1,25<=BMI<30, 2,visceral fat area=>120cm2, 3,35<=Age<65 of men and postmenopausal women, 4,provides informed consent in a documented form

Key exclusion criteria

1,liver, kidney and heart disease, or disorder of respiration, endocrine, metabolism, nervous system, consciousness, or diabetes, or other diseases, 2,surgery or therapy within 2 months before the trial, 3,medicine user for hyperglycaemia, lipidemia, or hypertension, 4,user of supplements or foods with health claim, 5,unpleasant feeling during blood drawing, 6,donated 200 mL or more blood within 1 month before the trial, 7,changed weight 2 kg or more within 1 month before the trial, 8,shiftworker, 9,plans business trip for 10 consecutive days or more, 10, allergy against any constituents in the test diet, 11, participant in the other trial or plan to be, 12, cannot provide informed consent, 13, judged to be inappropriate as subject by physician in charge

Target sample size

126


Research contact person

Name of lead principal investigator

1st name Atsuko
Middle name
Last name Mori

Organization

Oriental Ueno Kenshin Center

Division name

Head of center

Zip code

110-0005

Address

1-20-11 Ueno Taito-ku Tokyo 110-0005

TEL

03-5816-0711

Email

ueno-center@oriental-gr.com


Public contact

Name of contact person

1st name Toshiyasu
Middle name
Last name Tamura

Organization

TES Holdings Co. Ltd

Division name

Sales Department of Regenerative Medicine and Clinical Trials

Zip code

103-0027

Address

6F Univ. of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN

TEL

03-6801-8480

Homepage URL


Email

t.tamura@tes-h.co.jp


Sponsor or person

Institute

Oriental Ueno Kenshin Center

Institute

Department

Personal name



Funding Source

Organization

Health Care Food Research Laboratories, Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

the Ethical Committee of the Oriental Ueno Kenshin Center

Address

421-1, Zitoukata, Ugeo City

Tel

03-5816-0711

Email

ueno-center@oriental-gr.com


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

2016 Year 05 Month 10 Day


Related information

URL releasing protocol

Unpublished due to the protocol including the intellectual property rights

Publication of results

Published


Result

URL related to results and publications

http://onlinelibrary.wiley.com/doi/10.1002/oby.21938/epdf

Number of participants that the trial has enrolled

114

Results

Significant difference in the primary outcome between the groups

Results date posted

2019 Year 07 Month 25 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

overweight and obesity

Participant flow

126 were screened and 114 were analyzed

Adverse events

None associated with the test diets consumption

Outcome measures

visceral fat area

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2016 Year 04 Month 18 Day

Date of IRB

2016 Year 04 Month 18 Day

Anticipated trial start date

2016 Year 05 Month 30 Day

Last follow-up date

2017 Year 12 Month 17 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 04 Month 18 Day

Last modified on

2019 Year 07 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025166


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name