UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044866
Receipt number R000051246
Scientific Title A clinical study to evaluate the efficacy of body fat reduction by continuous ingestion of test food and exercise. ( SME-2021-02-FOSHUS)
Date of disclosure of the study information 2021/07/25
Last modified on 2022/09/13 08:18:15

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Basic information

Public title

A clinical study to evaluate the efficacy of body fat reduction by continuous ingestion of test food and exercise. ( SME-2021-02-FOSHUS)

Acronym

A clinical study to evaluate the efficacy of body fat reduction by continuous ingestion of test food and exercise.

Scientific Title

A clinical study to evaluate the efficacy of body fat reduction by continuous ingestion of test food and exercise. ( SME-2021-02-FOSHUS)

Scientific Title:Acronym

A clinical study to evaluate the efficacy of body fat reduction by continuous ingestion of test food and exercise.

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of body fat reduction by continuous ingestion of test food and exercise.

Basic objectives2

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

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

Prevention

Type of intervention

Food

Interventions/Control_1

Daily intake of test food and exercise for 12 weeks

Interventions/Control_2

Daily intake of control food and exercise for 12 weeks

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

Male and Female

Key inclusion criteria

(1) Males and females who are -> 20 years old at the time of IC acquisition and <65 years old at the end of the study.
(2) Subject, 25 kg/m2 <- BMI < 30 kg/m2.
(3) Those who can visit to destination medical institution on the scheduled date.
(4) Those who have submitted written informed consent after fully understanding the purpose and content of this study.

Key exclusion criteria

(1) Those who have regular hard exercise.
(2) Those who heavy use of alcohol or smoke.
(3) Those who continuously ingest foods for specified health use, foods with functional claims, health foods, and foods that may affect body fat evaluation.
(4) Those who continuously take medicines.
(5) Those who are participating in other study or planning to participate or participated within the past 4 weeks.
(6) Those who are:
a) heart, liver, or kidney disease (including complications of other diseases)
b) having a history of cardiovascular disease
c) diabetes
d) allergic to test foods
e) having a respiratory illness
(7) Others who are judged inappropriate for participant by the investigator.

Target sample size

148


Research contact person

Name of lead principal investigator

1st name Takao
Middle name
Last name Tanaka

Organization

Suntory Holdings Limited

Division name

Research Strategy Planning Department

Zip code

135-8631

Address

2-3-3 Daiba, Minato-ku, Tokyo, Japan

TEL

03-5579-1277

Email

Takao_Tanaka@suntory.co.jp


Public contact

Name of contact person

1st name Keisuke
Middle name
Last name Yasumoto

Organization

Suntory Holdings Limited

Division name

Research Strategy Planning Department

Zip code

135-8631

Address

2-3-3 Daiba, Minato-ku, Tokyo, Japan

TEL

03-3182-0496

Homepage URL


Email

Keisuke_Yasumoto@suntory.co.jp


Sponsor or person

Institute

Suntory Holdings Limited

Institute

Department

Personal name



Funding Source

Organization

SUNTORY BEVARAGE & 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

Fukuhara Clinic Clinical Trial Review Committee

Address

1-15, Shimamatsuhigashimachi-3-chome, Eniwa-shi, Hokkaido

Tel

0123-36-8029

Email

d-kameda@mediffom.co.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

2021 Year 07 Month 25 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

148

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

2021 Year 07 Month 14 Day

Date of IRB

2021 Year 07 Month 12 Day

Anticipated trial start date

2021 Year 07 Month 26 Day

Last follow-up date

2022 Year 01 Month 15 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 07 Month 14 Day

Last modified on

2022 Year 09 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051246


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name