UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018286
Receipt number R000021166
Scientific Title Preliminary study on the effect of the fish-derived component containing beverages on body fat in human
Date of disclosure of the study information 2015/07/21
Last modified on 2016/07/20 14:19:21

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Basic information

Public title

Preliminary study on the effect of the fish-derived component containing beverages on body fat in human

Acronym

Preliminary study on the effect of the fish-derived component containing beverages on body fat in human

Scientific Title

Preliminary study on the effect of the fish-derived component containing beverages on body fat in human

Scientific Title:Acronym

Preliminary study on the effect of the fish-derived component containing beverages on body fat in human

Region

Japan


Condition

Condition

obesity

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect and safety of the fish-derived component containing beverages on body fat in human.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Abdominal total fat area

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Fish-derived component containing beverage (low dose), 12 Weeks

Interventions/Control_2

Fish-derived component containing beverage (high dose), 12 Weeks

Interventions/Control_3

No fish-derived component containing beverage, 12 Weeks

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Subject who is 20 years of age or older.
2) Subject, 25 kg/m2 <= BMI < 30 kg/m2.
3) Subject who is able to give written informed consent before the study.

Key exclusion criteria

1) Subject receiving continuous medical treatment.
2) Subject with present disease such as liver disorder, kidney disorder, cardiac affection, diabetes mellitus.
3) Subject taking medication or functional foods, influencing the result of this study, such as medicine, food for specified health use, food with function claims supplement, diet food.
4) Subject with drug or food allergy
5) Female subject in pregnancy, lactation or intending to become pregnant during the study.
6) Subject deemed unsuitable by the investigator.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Junichi Nakamura

Organization

Suntory Global Innovation Center Limited

Division name

Research Institute

Zip code


Address

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan

TEL

050-3182-0460

Email

Junichi_Nakamura@suntory.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kayo Saito

Organization

Suntory Global Innovation Center Limited

Division name

Research Institute

Zip code


Address

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan

TEL

050-3182-0527

Homepage URL


Email

Kayo_Saito@suntory.co.jp


Sponsor or person

Institute

QOL RD Co.,Ltd.

Institute

Department

Personal name



Funding Source

Organization

Suntory Beverage & Food Limited

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


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

2015 Year 07 Month 21 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

2015 Year 06 Month 22 Day

Date of IRB


Anticipated trial start date

2015 Year 07 Month 21 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 07 Month 13 Day

Last modified on

2016 Year 07 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021166


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name