UMIN-CTR Clinical Trial

Public title

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

Acronym

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

Scientific Title

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

Region

Japan

Condition

Healthy Japanese

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the effects of consumption of the test food on fatigue and stress in healthy Japanese.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. The measured value of Total Mood Disturbance (TMD) score in the Profile of Mood States 2nd Edition (POMS2) at 12 weeks after consumption (12w) (Intervention 1 vs Intervention 3)

Key secondary outcomes

1. The measured value of TMD score in the POMS2 at 12w (Intervention 2 vs Intervention 3)
2. The measured values of Tension-Anxiety (TA), Depression-Dejection (DD), Anger-Hostility (AH), Vigor-Activity (VA), Fatigue-Inertia (FI), Confusion-Bewilderment (CB), Friendliness (F) in the POMS2 at 12w
3. The measured value of fatigue measured by visual analogue scale at 12w
4. The measured values of Physical Component Summary (PCS), Mental Component Summary (MCS), Role-social Component Summary (RCS), Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Emotional (RE), Mental Health (MH) in the MOS Short-Form 36-Item Health Survey at 12w
5. The measured values of "sleepiness on rising," "initiation and maintenance of sleep," "frequent dreaming," "refreshing," and "sleep length" in the OSA sleep inventory MA version (OSA-MA) at 12w
6. The measured value of each item in the OSA-MA at 12w
7. The measured values of high-sensitivity C-reactive protein, plasma cortisol, dehydroepiandrosterone sulfate at 12w
8. The measured value of each item in the POMS2 at 12w
9. The measured values of each symptom in the questionnaire of Kupperman Konenki Shogai Index (KKSI) at 12w (Women only)
10. The measured values of KKSI and each symptom complex (vasomotor symptoms, paresthesia, insomnia, nervousness, melancholia, vertigo, weakness/fatigue, arthralgia/myalgia, headache, palpitation, and formication) in the questionnaire of KKSI at 12w (Women only)
11. The measured values of estradiol, follicle-stimulating hormone, luteinizing hormone, and progesterone at 12w (Women only)
12. The measured value of free testosterone at 12w (Men only)
13. The measured values of low frequency (LF), high frequency (HF), LF/HF ratio, average heart rate, maximum heart rate, minimum heart rate, total power (TP), coefficient of component variance TP (ccvTP), deviation value of autonomic function, and autonomic functional age at 12w

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks
Test food: Pig placenta extract powder (contained in size 3 hard capsule)
Administration: Take five capsules with water without chewing after breakfast

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.

Interventions/Control_2

Duration: 12 weeks
Test food: Horse placenta extract powder (contained in size 3 hard capsule)
Administration: Take five capsules with water without chewing after breakfast

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.

Interventions/Control_3

Duration: 12 weeks
Test food: Starch, cornstarch, calcium stearate, particulate silicon oxide (contained in size 3 white hard capsule)
Administration: Take five capsules with water without chewing after breakfast

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.

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

65

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Japanese

2. Men or women

3. Individuals aged 20 or more and less than 65

4. Healthy individuals

5. Individuals whose TMD score in the POMS2 is relatively high among those who have agreed to participate

Key exclusion criteria

Individuals who
1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. have a pacemaker or an implantable cardioverter defibrillator
3. are currently undergoing treatment for cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
5. are taking medications (including herbal medicines) and supplements
6. are allergic to medicines and/or the test food related products (particularly pork or horses)
7. have mental health issues such as depression disorder, attention deficit/hyperactivity disorder, or other issues
8. have irregular sleeping time or habit due to work such as a late-night shift
9. have irregular lifestyles (such as diet, exercise, and sleep)
10. are undergoing medical treatment for chronic fatigue syndrome or menopausal syndrome
11. work in physical labor such as transportation of heavy objects
12. are undergoing treatment for premenstrual syndrome and/or premenstrual dysphoric disorder
13. are receiving counseling and/or psychotherapy
14. have undergone or are undergoing hormonal therapy
15. are usually taking food containing functional ingredients which may influence fatigue or stress (such as S-allyl cysteine, gamma-aminobutyric acid, lactic acid bacteria, reduced form of coenzyme Q10, paramylon derived from Euglena gracilis, docosahexaenoic acid, eicosapentaenoic acid, astaxanthin, citric acid, L-theanine, polyphenol derived from black soybean, 5-aminolevulinic acid phosphate, or anserine)
16. are pregnant, lactating, or planning to become pregnant during this study
17. have been enrolled in other clinical studies within 28 days before the agreeing to participate or plan to participate another study during this study
18. are judged as ineligible to participate by the physician

Target sample size

90

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

Japan Bio Products 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 Bldg., 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

2023

Year

12

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

102

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

2023

Year

11

Month

15

Day

Date of IRB

2023

Year

11

Month

15

Day

Anticipated trial start date

2023

Year

12

Month

06

Day

Last follow-up date

2024

Year

07

Month

16

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

12

Month

06

Day

Last modified on

2024

Year

09

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060483