UMIN-ICDS Clinical Trial

Public title

Examination of the effect of test food intake on fatigue in healthy adults
-Randomized, double-blind, placebo-controlled, parallel-group study-

Acronym

Examination of the effect of test food intake on fatigue

Scientific Title

Examination of the effect of test food intake on fatigue in healthy adults
-Randomized, double-blind, placebo-controlled, parallel-group study-

Scientific Title:Acronym

Examination of the effect of test food intake on fatigue

Region

Japan

Condition

None

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effect of test food intake on fatigue

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Changes in subjective measures of fatigue

Key secondary outcomes

- Changes in other subjective psychological measures
- Specific measurement of blood
- Specific measurement of saliva

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Intakes of test food for 8 days

Interventions/Control_2

Intakes of placebo 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

59

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Male and female individuals aged 20 to 59 years at the time of providing informed consent
(2) Individuals judged to be in good health by the principal investigator
(3) Individuals who are prone to experiencing fatigue in their daily lives
(4) Individuals who are able to attend the designated study visits and undergo the required examinations
(5) Individuals who have received a full explanation of the purpose and contents of the study, have the capacity to provide informed consent, voluntarily agree to participate with sufficient understanding, and provide written informed consent
(6) Individuals who are deemed eligible for participation in this study by the principal investigator

Key exclusion criteria

(1) Individuals who have any disease requiring pharmacological treatment, or who regularly use medications or quasi-drugs for purposes other than treating a disease
(2) Individuals who are unable to discontinue the use of health foods (including Foods for Specified Health Uses and Foods with Functional Claims) or designated quasi-drugs during the study period
(3) Individuals who have, are being treated for, or have a history of any of the following conditions: diabetes mellitus; renal, hepatic, or cardiovascular diseases; thyroid or adrenal disorders; sleep disorders (e.g., insomnia, sleep apnea syndrome, hypersomnia); cognitive impairment; psychiatric disorders; gastrointestinal diseases; respiratory diseases; peripheral vascular disorders; urea cycle disorders; hyperammonemia; other metabolic diseases; or other serious illnesses
(4) Individuals receiving treatment for stress-related conditions, or using medications, supplements, or health foods (including Foods with Functional Claims) related to such treatments
(5) Individuals currently taking antihistamines
(6) Individuals with a score of 16 points or higher (severe) on the Quick Inventory of Depressive Symptomatology (QIDS-J)
(7) Individuals diagnosed with chronic fatigue syndrome (CFS), or those judged by the principal investigator or sub-investigator to have severe fatigue (e.g., acute or chronic fatigue conditions)
(8) Individuals with a history or current condition of drug or alcohol dependence
(9) Individuals who habitually consume excessive amounts of alcohol (defined as an average daily intake exceeding 20 g of pure alcohol)
(10) Individuals who are prone to dizziness or palpitations during exercise, or who have been advised by a physician to restrict physical activity
(11) Individuals who have engaged in habitual moderate-to-vigorous exercise (e.g., jogging, resistance training, or ball sports) at least twice per week within the past 3 months

(12) and beyond are described in Other related information.

Target sample size

130

Name of lead principal investigator

1st name	Masahiko
Middle name
Last name	Morita

Organization

Kirin Holdings Company, Limited

Division name

Institute of Health Sciences

Zip code

2518555

Address

Shonan Health Innovation Park, 2-26-1, Muraoka-Higashi, Fujisawa, Kanagawa, Japan

TEL

090-3063-2127

Email

Masahiko_Morita@kirin.co.jp

Name of contact person

1st name	Makoto
Middle name
Last name	Terashima

Organization

Oneness Support Co., Ltd.

Division name

Clinical Trial Division

Zip code

5300044

Address

Higashitenma Building 6F 1-7-17 Higashitenma, Kita-ku, Osaka, Japan

TEL

06-4801-8917

Homepage URL

Email

mterashima@oneness-sup.co.jp

Institute

Kirin Holdings Company, Limited

Institute

Department

Personal name

Organization

Kirin Holdings Company, Limited

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Research Ethical Review Committee of Kirin Holdings Company, Ltd.

Address

Nakano Central Park South, 4-10-2, Nakano, Nakano-ku, Tokyo, Japan

Tel

03-6837-4128

Email

02976_Ni@kirin.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

医療法人花音会みうらクリニック（大阪府）

Date of disclosure of the study information

2026

Year

08

Month

06

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

2026

Year

07

Month

29

Day

Date of IRB

2026

Year

07

Month

29

Day

Anticipated trial start date

2026

Year

11

Month

01

Day

Last follow-up date

2027

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

"Key exclusion criteria"
(12) Individuals who may develop allergic reactions to components contained in the test food, or who have a history of severe allergic reactions to foods or medications
(13) Individuals with severe anemia
(14) Individuals with a body mass index (BMI) of less than 18.5 kg/m2 or 25.0 kg/m2 or higher
(15) Individuals who are expected to experience, or have experienced during the study period, major life events that may significantly affect mental status (e.g., marriage, divorce, job change, relocation, bereavement, illness of a close relative, unemployment)
(16) Individuals employed by companies engaged in the development, manufacture, or sale of foods with functional claims
(17) Individuals with a smoking habit (including those who have smoked occasionally or daily within the past 3 months)
(18) Individuals who are engaged in shift work or who are unable to maintain regular nocturnal sleep due to other reasons
(19) Individuals who are currently participating in, or intend to participate in, other clinical studies involving ingestion of foods, use of medications, or application of cosmetics or pharmaceuticals during the study period
(20) Individuals who are currently breastfeeding, pregnant, or may become pregnant, or who intend to become pregnant during the study period
(21) Individuals currently on a diet
(22) Individuals with extremely irregular dietary habits
(23) Any individuals deemed unsuitable for participation in this study by the principal investigator or sub-investigator

Registered date

2026

Year

07

Month

31

Day

Last modified on

2026

Year

07

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071432