UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047704
Receipt number R000054390
Scientific Title Effects of consumption of the test food on fatigue and stress in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Date of disclosure of the study information 2022/05/10
Last modified on 2023/08/24 14:30:31

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Basic information

Public title

Effects of consumption of the test food on fatigue and stress in healthy Japanese subjects

Acronym

Effects of consumption of the test food on fatigue and stress in healthy Japanese subjects

Scientific Title

Effects of consumption of the test food on fatigue and stress in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Scientific Title:Acronym

Effects of consumption of the test food on fatigue and stress in healthy Japanese subjects

Region

Japan


Condition

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the effects of 12-week consumption of the test food on fatigue and stress in healthy Japanese subjects

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1. The difference in fatigue measured by VAS (visual analogue scale) before and after workload at 12 weeks after consumption (12w)

Key secondary outcomes

1. The fatigue measured by VAS before workload at 12w

2. The fatigue measured by VAS after workload at 12w

3. The following items of the test of the autonomic nervous system at 12w (before and after workload and the difference of them): LF (low frequency), HF (how frequency), LF/HF ratio, average heart rate, maximum heart rate, minimum heart rate, TP (total power), ccvTP (coefficient of component variance TP), deviation value of autonomic function, and autonomic functional age

4. The d-ROMs (diacron reactive oxygen metabolites), BAP (biological antioxidant potential), d-ROMs/BAP ratio, and BAP/d-ROMs at 12w


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration

Institution is not considered as adjustment factor.

Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks
Test food: Tablet containing ripened Korean red ginseng extract (108 mg/tablet)
Administration: Take two tablets with water at any time during the day

*Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.

Interventions/Control_2

Duration: 12 weeks
Test food: Tablet containing ripened Korean red ginseng extract (162 mg/tablet)
Administration: Take two tablets with water at any time during the day

*Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.

Interventions/Control_3

Duration: 12 weeks
Test food: Placebo tablet
Administration: Take two tablets with water at any time during the day

*Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.

Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese

2. Men or women

3. Adults

4. Healthy subjects

5. Subjects who usually feel tired or stress easily

6. Subjects who are judged as eligible to participate in the study by the physician

7. Subjects whose the difference in VAS for fatigue before and after workload are large positively

Key exclusion criteria

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Subjects who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Subjects who are undergoing medical treatment for chronic fatigue syndrome or menopausal syndrome

5. Subjects whose sleeping time or habit is irregular due to working a late-night shift

6. Subjects who have physical labor such as transportation of heavy objects

7. Subjects who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use

8. Subjects who currently taking medications (including herbal medicines) and supplements

9. Subjects who are allergic to medicines and/or the test food related products

10. Subjects who are pregnant, lactation, or planning to become pregnant

11. Subjects who suffer from COVID-19

12. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial

13. Subjects who are judged as ineligible to participate in the study by the physician

Target sample size

102


Research contact person

Name of lead principal investigator

1st name Tsuyoshi
Middle name
Last name Takara

Organization

Medical Corporation Seishinkai, Takara Clinic

Division name

Director

Zip code

141-0022

Address

9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

TEL

03-5793-3623

Email

t-takara@takara-clinic.com


Public contact

Name of contact person

1st name Naoko
Middle name
Last name Suzuki

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Homepage URL


Email

nao@orthomedico.jp


Sponsor or person

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name



Funding Source

Organization

KIM's Korean Ginseng Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Name of secondary funder(s)



IRB Contact (For public release)

Organization

the ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.

Tel

03-5793-3623

Email

IRB@takara-clinic.com


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)


Other administrative information

Date of disclosure of the study information

2022 Year 05 Month 10 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

111

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



Progress

Recruitment status

Completed

Date of protocol fixation

2022 Year 04 Month 20 Day

Date of IRB

2022 Year 04 Month 20 Day

Anticipated trial start date

2022 Year 04 Month 28 Day

Last follow-up date

2022 Year 12 Month 21 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 05 Month 10 Day

Last modified on

2023 Year 08 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054390


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name