UMIN-CTR Clinical Trial

Public title

Effects of consumption of the test food on fatigue and stress

Acronym

Effects of consumption of the test food on fatigue and stress

Scientific Title

Effects of consumption of the test food on fatigue and stress: A randomized double-blind placebo-controlled trial

Scientific Title:Acronym

Effects of consumption of the test food on fatigue and stress

Region

Japan

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the effects of 12-week consumption of the test food on fatigue and stress

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The measured value of visual analogue scale (VAS) of fatigue before and after workload at 12 weeks after consumption (12w)

Key secondary outcomes

1. The measured value of VAS of fatigue before workload at 12w

2. The measured value of VAS of fatigue after workload at 12w

3. The amount of change of VAS of fatigue before and after workload between screening (before consumption; Scr) and 12w

4. The amount of change of VAS of fatigue before workload between Scr and 12w

5. The amount of change of VAS of fatigue after workload between Scr and 12w

6. The measured values and the amount of changes of following items between Scr and 12w: TMD (Total Mood Disturbance), TA (Tension-Anxiety), DD (Depression-Dejection), AH (Anger-Hostility), VA (Vigor-Activity), FI (Fatigue-Inertia), CB (Confusion-Bewilderment), F (Friendliness), and each question item of POMS2 (Profile of Mood States 2nd Edition), LF (Low Frequency), HF (High Frequency), LF/HF, average heart rate, maximum heart rate, minimum heart rate, TP (total power), ccvTP (coefficient of component variance total power), deviation value of autonomic function, autonomic functional age, cortisol level, and amylase activity (evaluate the values before, after, and before and after workload for each variable)

7. The measured values and the amount of changes of d-ROMs and BAP between Scr and 12w

8. The measured values of original questionnaires (The Likert scale method) at 12w weeks after consumption

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

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks
Test food: Tablet containing ripened Korean red ginseng extract
Administration: Take two tablets with water at any time during 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: Placebo
Administration: Take two tablets with water at any time during the day.

*If you forget to take the test food, take it as soon as you remember within the day.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Healthy Japanese adult subjects

2. Subjects who feel fatigue or stress in daily

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

4. Subjects whose amount of changes of VAS of fatigue increased at a relatively larger rate before and after workload

Key exclusion criteria

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

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

3. Subjects 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 who work late-night shift and the life-styles are irregular

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 currently taking medicines (include herbal medicines) and supplements

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

10. Subjects who are pregnant, breast-feeding, and planning to become pregnant

11. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in another clinical trial during trial period

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

Target sample size

52

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

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

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

KIM's Korean Ginseng Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Name of secondary funder(s)

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

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)

Date of disclosure of the study information

2020

Year

11

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

56

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

2020

Year

11

Month

11

Day

Date of IRB

2020

Year

11

Month

11

Day

Anticipated trial start date

2020

Year

11

Month

13

Day

Last follow-up date

2021

Year

05

Month

29

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

11

Month

13

Day

Last modified on

2022

Year

03

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048450