UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035949
Receipt number R000040766
Scientific Title Effects of the Test Food for Physical Fatigue.
Date of disclosure of the study information 2019/08/09
Last modified on 2019/08/08 17:30:13

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Basic information

Public title

Effects of the Test Food for Physical Fatigue.

Acronym

Effects of the Test Food for Physical Fatigue.

Scientific Title

Effects of the Test Food for Physical Fatigue.

Scientific Title:Acronym

Effects of the Test Food for Physical Fatigue.

Region

Japan


Condition

Condition

N/A(healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to evaluate effects of the Test food for physical fatigue and its safety.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

[1]Indexes for evaluating fatigue (Visual Analogue Scale for fatigue and menopause , Japanese Translation of Chalder Fatigue Scale , Japanese Translation of Profile of Mood States).

Key secondary outcomes

*Safety
[1]Blood pressure, pulsation.
[2]Weight, body fat percentage, BMI.
[3]Doctor's questions.
[4]Subject's diary.


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


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Oral ingestion of the test product A

Interventions/Control_2

Oral ingestion of the test product B

Interventions/Control_3

Oral ingestion of the placebo product

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

30 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

[1]Japanese males aged 30-64 years.
[2]Individuals who are healthy and are not received treatment of disease.
[3]Individuals who have daily fatigue.
[4]Individuals who have shoulder stiffness, lower back pain, or eyestrain derived from fatigue.
[5]Individuals who work on daytime from Monday to Friday and have Saturdays and Sundays off.
[6]Individuals whose written informed consent has been obtained.
[7]Individuals who can come to the designated venue for this study and be inspected.
[8]Individuals judged appropriate for the study by the principal.

Key exclusion criteria

[1]Individuals who have chronic fatigue.
[2]Individuals using medical products.
[3]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[4]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis).
[5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
[6]Individuals who are a patient or have a history of or endocrine disease.
[7]Individuals whose BMI is over 30.
[8]Individuals with serious anemia.
[9]Individuals who are sensitive to a test product or other foods, and medical products.
[10]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day).
[11]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period.
[12]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements with components contained in the test product in the past 3 month or will ingest those foods during the test period.
[13]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period.
[14]Individuals who are or are possibly, or are lactating.
[15]Individuals who participated in other clinical studies in the past 3 months.
[16]Individuals who are or whose family is engaged in functional foods or cosmetics.
[17]Individuals judged inappropriate for the study by the principal.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Takahiro
Middle name
Last name Ono

Organization

Ueno-Asagao Clinic

Division name

Head

Zip code

110-0015

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-3-6240-1162

Email

info@ueno-asagao.clinc


Public contact

Name of contact person

1st name Ryoma
Middle name
Last name Shimizu

Organization

TES Holdings Co., Ltd.

Division name

Administrative Department of Clinical Trials

Zip code

110-0015

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-3-6801-8480

Homepage URL


Email

r.shimizu@tes-h.co.jp


Sponsor or person

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Taiyo Kagaku Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Ethics Committee of the Oriental Ueno Detection Center, General Incorporated Association Oriental Occupational Health Association Tokyo Branch

Address

1-20-11 Ueno Taito-ku Tokyo 110-0005, JAPAN

Tel

+81-3-5816-0711

Email

jimukyoku@tes-h.co.jp


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



Other administrative information

Date of disclosure of the study information

2019 Year 08 Month 09 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


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

2019 Year 02 Month 06 Day

Date of IRB

2019 Year 01 Month 24 Day

Anticipated trial start date

2019 Year 02 Month 20 Day

Last follow-up date

2019 Year 03 Month 23 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 02 Month 20 Day

Last modified on

2019 Year 08 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040766


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name