UMIN-ICDS Clinical Trial

Public title

An Exploratory Study on the Effects of a Test Food Product on Physical Performance, Immune Function, and Cognitive Function

Acronym

An Exploratory Study on the Effects of a Test Food Product on Physical Performance, Immune Function, and Cognitive Function

Scientific Title

An Exploratory Study on the Effects of a Test Food Product on Physical Performance, Immune Function, and Cognitive Function

Scientific Title:Acronym

An Exploratory Study on the Effects of a Test Food Product on Physical Performance, Immune Function, and Cognitive Function

Region

Japan

Condition

Male/female adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effects of consuming a test food product on the maintenance of physical performance, immune function, and cognitive function in middle-aged and older adults.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

VO2max
Changes in heart rate during exercise
Changes in Borg Scale ratings before and after exercise
Skeletal muscle mass
Handgrip strength
Lower-limb muscle strength
Timed Up and Go (TUG) test
Natural killer (NK) cell activity
Interleukin-6 (IL-6)
Growth differentiation factor 15 (GDF15)
Lipopolysaccharide (LPS)
Cognitrax cognitive test scores
Athens Insomnia Scale score

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

Oral consumption of the test food (1 capsule, once daily) for 8 weeks

Interventions/Control_2

Oral consumption of the placebo food (1 capsule, once daily) for 8 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

55

years-old

<=

Age-upper limit

70

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Males and females aged 55 years to less than 70 years at the time of informed consent acquisition.
2. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.

Key exclusion criteria

1. Individuals engaged in physically demanding occupations such as heavy lifting.
2. Individuals who have maintained a habitual exercise routine for more than 1 year, consisting of 30 minutes or over of exercise at least twice per week. (Light daily activities such as casual walking are not considered habitual exercise; however, resistance training, dance, ball sports, and similar structured exercise are included.)
3. Individuals with irregular lifestyle patterns, including rotating shift work.
4. Individuals who have sustained injuries affecting physical function (e.g., fractures, tendon ruptures) within the past year.
5. Individuals who regularly consume Foods for Specified Health Uses, Foods with Function Claims, or health foods (including supplements) with claims (e.g., products marketed for reducing fatigue) and are unable to discontinue their use after providing consent.
6. Individuals who have routinely taken supplements containing vitamin D, amino acids, or polyunsaturated fatty acids (DHA/EPA) within the past 3 months, and are unable to discontinue their use after providing consent.
7. Individuals who routinely take medications or quasi-drugs that may affect the study outcomes (e.g., nutritional tonics for physical fatigue, restorative tonics, antibiotics, DHA/EPA-containing products) and who are unable to discontinue their use after providing consent.
8. Individuals who have taken steroids or hormonal agents (e.g., androgen- or estrogen-containing compounds) that may affect muscle function within the past 3 months, and those who cannot discontinue such agents after providing consent.
9. Individuals with limitations in activities of daily living, including those who require the use of a cane.
10. Individuals with excessive alcohol intake.
11. Individuals who have previously been identified as having electrocardiographic abnormalities during health examinations.

Target sample size

40

Name of lead principal investigator

1st name	Fumiko
Middle name
Last name	Nakamura

Organization

CPCC Company Limited

Division name

Clinical Support Department

Zip code

103-0021

Address

4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan

TEL

03-6225-9001

Email

cpcc-contact@cpcc.co.jp

Name of contact person

1st name	Masanori
Middle name
Last name	Numa

Organization

CPCC Company Limited

Division name

Clinical Planning Department

Zip code

103-0021

Address

4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan

TEL

03-6225-9001

Homepage URL

Email

cpcc-contact@cpcc.co.jp

Institute

CPCC Company Limited

Institute

Department

Personal name

Organization

TIME TRAVELER Corp.

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 Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan

Tel

03-6225-9005

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

2025

Year

12

Month

02

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

2025

Year

11

Month

27

Day

Date of IRB

2025

Year

11

Month

21

Day

Anticipated trial start date

2025

Year

12

Month

03

Day

Last follow-up date

2026

Year

04

Month

03

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

(Exclusion criteria continued)
12. Individuals with a past or current history of severe diseases of the heart, liver, kidneys, gastrointestinal or respiratory systems (particularly gastrointestinal disorders affecting digestion or absorption) or musculoskeletal conditions such as rheumatoid arthritis or osteoarthritis of the knee.
13. Individuals with allergies to medications and/or food.
14. Individuals who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods.
15. Individuals who donated 200 mL of their blood or blood components within the last month.
16. Individuals who donated 400 mL of his blood within the last 3 months.
17. Individuals who donated 400 mL of her blood within the last 4 months.
18. Individuals who have had a total of 1200 mL of his blood collected within the last 12 months, including in this study.
19. Individuals who have had a total of 800 mL of her blood collected within the last 12 months, including in this study.
20. Individuals deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.

Registered date

2025

Year

12

Month

02

Day

Last modified on

2025

Year

12

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068173