UMIN-ICDS Clinical Trial

Public title

Evaluation of effects induced by ingesting test foods on fat metabolism at rest.

Acronym

To evaluate the effects of intake of test food on fat metabolism at rest.

Scientific Title

To evaluate the effects of intake of test food on fat metabolism at rest.

Scientific Title:Acronym

To evaluate the effects of intake of test food on fat metabolism at rest.

Region

Japan

Condition

Healthy male adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify some kind of effect of a single intake, and continuous intakes of the food ingredient on fat metabolism at rest for male subjects ranging in age from 20 to 49 years old.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Fat oxidation

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

To begin with, subjects will take the food-1 for 8 days. After more than 5 days of washout period, subjects will take the food-2 for 8 days.

Interventions/Control_2

To begin with, subjects will take the food-2 for 8 days. After more than 5 days of washout period, subjects will take the food-1 for 8 days.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

50

years-old

>

Gender

Male

Key inclusion criteria

(1) Male subjects ranging in age from 20 to 49 at informed consent.
(2) Subjects ranging in BMI from 18.5 to less than 25.0 kg/m2.
(3) Subjects who can visit the designated facility on measurement days.
(4) Subjects who can make self-judgment and voluntarily gave written informed consent.

Key exclusion criteria

(1) Subjects who have a habit of exercises.
(2) Subjects who can not brethe naturally using an aeromonitor.
(3) with irregular life rhythm (e.g., irregular shift work).
(4) Subjects with excessive alcohol intake.
(5) Subjects having a habit of smoking.
(6) Subjects with dieting or planning to diet during this study.
(7) Subjects having serious allergic rhinitis.
(8) Subjects who have periodically used health-specific / functional / health foods including supplements, which might affect fat metabolism.
(9) Subjects who take affecting medicines (except nonaffecting painkiller/antiinflamentry/external/eyedrops) within a month before the consent.
(10) Subjects with a maximal blood pressure of less than 90 mmHg.
(11) Subjects who donated their blood components and/or whole blood (0.2 L) within the past 4 weeks.
(12) Subjects who donated their whole blood (0.4 L) within the past 12 weeks.
(13) Subjects being collected in total of their blood (1.2 L) within the past 12 months and in this research.
(14) Subjects being under other clinical tests, or partook in those within the past four weeks, or will join those after the consent.
(15) Subjects who meet any of the following:
(a) suffering from heart, liver, or kidney disease (including complications of other diseases)
(b) having a history of cardiovascular disease
(c) diabetes
(d) allergic to the test food and required one.
(16) Others who were judged as inappropriate for participation by the principal/sub investigator.

Target sample size

20

Name of lead principal investigator

1st name	Hisako
Middle name
Last name	Minami

Organization

Suntory beverage & Food limited.

Division name

Development & Designed Department

Zip code

211-0067

Address

13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN

TEL

050-3182-6161

Email

Hisako_Nakamura@suntory.co.jp

Name of contact person

1st name	Mariko
Middle name
Last name	Sato

Organization

Suntory beverage & Food limited.

Division name

Development & Designed Department

Zip code

211-0067

Address

13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN

TEL

050-3182-0954

Homepage URL

Email

Mariko_Sato@suntory.co.jp

Institute

CPCC Company Limited

Institute

Department

Personal name

Organization

Suntory beverage & Food limited.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan

Tel

03-5297-5548

Email

IRB@cpcc.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

12

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2022

Year

12

Month

20

Day

Date of IRB

2022

Year

12

Month

16

Day

Anticipated trial start date

2023

Year

01

Month

05

Day

Last follow-up date

2023

Year

08

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

12

Month

21

Day

Last modified on

2024

Year

01

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056757