UMIN-ICDS Clinical Trial

Public title

Clinical study to confirm anti-sarcopenia effect of test food.

Acronym

Clinical study to confirm anti-sarcopenia effect of test food.

Scientific Title

Clinical study to confirm anti-sarcopenia effect of test food.

Scientific Title:Acronym

Clinical study to confirm anti-sarcopenia effect of test food.

Region

Japan

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the anti-sarcopenia efficacy and safety of ingestion of test food for 12 weeks

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Soft lean mass
Body fat mass

Key secondary outcomes

Timed Up & Go Test
Grip strength
Knee extension strength
Growth hormone
Falls efficacy scale

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

Ingestion of test food containing functional substance for 12 weeks

Interventions/Control_2

Ingestion of placebo 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

Age-lower limit

40

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Healthy males and females aged 40 and over who are aware of a decline in muscle strength due to aging
(2) Subjects with a score of 1.1 or more and less than 1.3 in two-step test conducted in the screening examination
(3) Subjects who can understand the purpose and content of this study and voluntarily agree to participate in this study

Key exclusion criteria

Subjects
(1) who have or have a history of any disease that may affect the evaluation of the study
(2) who have difficulty in daily activities or walking due to severe pain, or who are unable to perform exercise training
(3) diagnosed with sarcopenia
(4) who have a possibility of recurrence of locomotory disease due to exercise training
(5) who regularly use health foods that may affect the evaluation of the study
(6) who regularly use pharmaceuticals
(7) who exercise regularly
(8) who exercise excessively
(9) with a history of locomotory disease within 1 year before the screening examination
(10) who use canes or supporters
(11) who periodically conduct actions that may affect the evaluation of effectiveness
(12) who are under treatment of diseases on the joints
(13) who have or have a history of severe diseases
(14) who are under treatment or have a history of mental diseases
(15) who have unsteady lifestyle or who work manual labor
(16) who drink a lot
(17) who have possibilities for emerging allergy onset related to the study
(18) who are judged as unsuitable for the study based on the results of screening examination
(19) who have participated in other clinical study within a month before the screening test or who intend to participate in the study period
(20) who are in a pregnancy or lactation period in the study period
(21) who are judged as unsuitable due to lifestyle questionnaire
(22) who cannot carry out the test as instructed
(23) who are judged as unsuitable for the study by investigator for other reasons

Target sample size

50

Name of lead principal investigator

1st name	Hideki
Middle name
Last name	Hokazono

Organization

Sanwa Shurui Co., Ltd.

Division name

Sanwa Laboratory

Zip code

879-0495

Address

2231-1, Yamamoto, Usa City, Oita

TEL

0978-33-3844

Email

hokazono-h@kokuzo.co.jp

Name of contact person

1st name	Mariko
Middle name
Last name	Kondo

Organization

EP Mediate Co., Ltd.

Division name

Foods Department, Trial Planning Section 2

Zip code

162-0821

Address

Kagurazaka AK Bldg., 1-8, Tsukudo-cho, Shinjuku-ku, Tokyo

TEL

070-3023-8211

Homepage URL

Email

kondo.mariko793@eps.co.jp

Institute

EP Mediate Co., Ltd

Institute

Department

Personal name

Organization

Sanwa Shurui Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

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

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

2023

Year

01

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

50

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

2023

Year

01

Month

26

Day

Date of IRB

2023

Year

01

Month

26

Day

Anticipated trial start date

2023

Year

01

Month

31

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

2023

Year

01

Month

26

Day

Last modified on

2023

Year

12

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057025