UMIN-ICDS Clinical Trial

Public title

Effect of food-containing ingredients for motor function (SIC-2022-10-GUTS)

Acronym

Effect of food-containing ingredients for motor function

Scientific Title

Effect of food-containing ingredients for motor function (SIC-2022-10-GUTS)

Scientific Title:Acronym

Effect of food-containing ingredients for motor function

Region

Japan

Condition

Not applicable

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effect of food-containing ingredients for motor function.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Whole body fat-free mass

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

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of Iingredient-containing food 1 and exercise(12 weeks)

Interventions/Control_2

Intake of iIngredient-containing food 2 and exercise(12 weeks)

Interventions/Control_3

Intake of Iingredient-free food and exercise(12 weeks)

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

40

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

(1) Subjects who can make self-judgment and are voluntarily giving written informed consent.
(2) From 40 to 64 years healthy men and women.
(3) Subjects who can receive explanations and inspections in a remote environment.
(4) Subjects who can visit the facility on designated day.

Key exclusion criteria

(1) Subjects whose systolic blood pressure is less than 90mmHg
(2) Subjects who wish to become pregnant during the examination period, or in pregnancy or lactation
(3) Subjects who are participating in other clinical studies for drug medicine or food, or who finished clinical study within four weeks
(4) Subjects who are applicable to following items;
a) Subjects with disease on heart, liver, kidney or other organs complication.
b) Subjects with a previous history of disease on circulatory organs.
c) Subjects who are contracting diabetes.
d) Subjects with respiratory disease.
e) Subjects undergoing treatment for or with a history of cancer, tuberculosis, or other serious illness
(5) Subjects who have an unsteady lifestyle because of a working shift or a night shift.
(6) Subjects who drink a lot.
(7) Subjects who smoke more than 21 cigarettes/day
(8) Subjects who are judged as unsuitable for the study by the result of clinical examination and/or physical examination.
(9) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.

Target sample size

60

Name of lead principal investigator

1st name	Noriyuki
Middle name
Last name	Kanzaki

Organization

Suntory Global Innovation Center Ltd.

Division name

Research Institute

Zip code

619-0284

Address

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

TEL

05031820666

Email

Noriyuki_Kanzaki@suntory.co.jp

Name of contact person

1st name	Takayuki
Middle name
Last name	Yasui

Organization

Suntory Global Innovation Center Ltd.

Division name

Research Institute

Zip code

619-0284

Address

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

TEL

050-3182-6901

Homepage URL

Email

Takayuki_Yasui@suntory.co.jp

Institute

Suntory Global Innovation Center Ltd.

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Medical Station Clinic Research Ethics Committee

Address

3-12-8, Takaban, Meguroku, Tokyo

Tel

03-6452-2712

Email

nakagawa.akiko297@eps.co.jp

Secondary IDs

YES

Study ID_1

00490-0002

Org. issuing International ID_1

EP Mediate Co., Ltd.

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

02

Month

12

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

Preinitiation

Date of protocol fixation

2022

Year

12

Month

22

Day

Date of IRB

Anticipated trial start date

2023

Year

02

Month

13

Day

Last follow-up date

2023

Year

08

Month

10

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

12

Month

28

Day

Last modified on

2022

Year

12

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056879