UMIN-CTR Clinical Trial

Public title

Verification of the effects of test foods on daily fatigue in healthy adults .

Acronym

Verification of the effects of test foods on daily fatigue in healthy adults .

Scientific Title

Verification of the effects of test foods on daily fatigue in healthy adults .
: Placebo-controlled, double-blind, randomized, parallel-group comparison study

Scientific Title:Acronym

Verification of the effects of test foods on daily fatigue in healthy adults .
: Placebo-controlled, double-blind, randomized, parallel-group comparison study

Region

Japan

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Examining the effects of research food intake on daily fatigue

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Fatigue survey using Visual Analogue Scale

Key secondary outcomes

Sleep quality survey using OSA sleep inventory MA version

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 research food for 12 weeks

Interventions/Control_2

Ingestion of placebo food 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

20

years-old

<=

Age-upper limit

64

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Subjects of men and women aged 20 to 64
(2) Subject who feel fatigue and mental fatigue due to the Uchida-Kraepelin performance test
(3) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.

Key exclusion criteria

(1) Subjects suffering from, undergoing treatment for, or with a history of diabetes mellitus, renal or hepatic disease, cardiac disease or other serious diseases, thyroid disease, adrenal disease, or other metabolic diseases.
(2) Subjects who have a chronic disease and are currently undergoing treatment, have chronic fatigue syndrome (CFS), are receiving treatment for a sleep disorder, or for whom treatment is deemed necessary by the principal investigator or study investigator.
(3) Subjects who reported having food allergies (especially gelatin) related to the test foods.
(4) Subjects with a history of gastrointestinal diseases affecting digestion and absorption or gastrointestinal surgery (excluding appendicitis)
(5) Subjects who regularly use medicines(includng herbal medicines) or quasi-drugs that my affect immunity, fatigue, oy sleep quality
(6) Subjects who have a habit of consuming food products, healty foods(including foods for specified healty uses, functional foods, and supplements), or lactbacillus preparations containing a large amount of acetic acid bacteria (such as nigori vinegar), lactic acid bacteria, or bifidobacteria (such as lactic acid bacteria drinks, yogurt, kimchi) at least 3 times a week from the time of appliciation for study participation until the 12-week intake test day
(7) Subjects who are unable to discontinue consumption of health food (including food for specifird health uses, food with functional claims, and supplements) and designated quasi-drugs during the study period
(8) Subjects who work day and night shifts or engage in physical labor such as heavy lifting.
(9) Subjects who habitually engage in strenuous sports such as marathon running during the test period (including professional athletes) and subjects on a diet
(10) to (19) are listed in the "Other related information" column

Target sample size

100

Name of lead principal investigator

1st name	Miura
Middle name
Last name	Naoki

Organization

Miura Clinic, Medical Corporation Kanonkai

Division name

Miura Clinic, Medical Corporation Kanonkai

Zip code

5300044

Address

Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka

TEL

06-6135-5200

Email

info@miura-cl.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

TEL

06-4801-8917

Homepage URL

Email

mterashima@oneness-sup.co.jp

Institute

Miura Clinic, Medical Corporation Kanonkai

Institute

Department

Personal name

Organization

Kewpie Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai

Address

Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka

Tel

06-6135-5200

Email

mterashima@miura-cl.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

2024

Year

02

Month

14

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

2024

Year

01

Month

23

Day

Date of IRB

2024

Year

01

Month

25

Day

Anticipated trial start date

2024

Year

03

Month

19

Day

Last follow-up date

2024

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

"Key exclusion sriteria"
(10) Pregnant, intending to become pregnant during study participation, or lactating subjects.
(11) Subjects who are determined to be unsuitable for the study based on the results of screening tests.
(12) Subjects who deviated from the proper level of alcohol consumption (average of approximately 20 g of pure alcohol per day)
(13) Subjects who smoke an average of 21 or more cigarettes per day
(14) Subjects with a history or current history of drug or alcohol dependence
(15) Subjects with extremely irregular eating habits
(16) Subjects who are unable to perform the various testing procedures to be conducted during the study period as specified.
(e.g., responses to questionnaires)
(17) Subjects who are currently participating in a study involving the ingestion of other foods or the use of drugs, or the application of cosmetics and medicines, or who have participated in other clinical trials within 1 month of obtaining consent, or who have participated in other clinical trials within 1 month of obtaining consent, or who are willing to participate.
(18) Subjects who plan to travel abroad during the examination period.
(19) Subjects who are judged to be unsuitable for the study by the investigator.

Registered date

2024

Year

02

Month

13

Day

Last modified on

2024

Year

12

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061142