UMIN-CTR Clinical Trial

Public title

Examination on an effect of continuous intake of a test food product on relieving a feeling of fatigue

Acronym

Examination on an effect of continuous intake of a test food product on relieving a feeling of fatigue

Scientific Title

Examination on an effect of continuous intake of a test food product on relieving a feeling of fatigue

Scientific Title:Acronym

Examination on an effect of continuous intake of a test food product on relieving a feeling of fatigue

Region

Japan

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine an effect of a test food product on reliving a feeling of fatigue after an exercise stress test by selecting those who are aged 30 and over, below 45 and have no exercise habit and assigning them to take the test food product for 1 week on a continuous basis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Creatine kinase,VAS

Key secondary outcomes

Hematologic test, blood biochemical test, vital signs

Study type

Interventional

Basic design

Cross-over

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

Central registration

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

1-week intake of the test food
Wash out
1-week intake of the placebo

Interventions/Control_2

1-week intake of the placebo
Wash out
1-week intake of the test food

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

30

years-old

<=

Age-upper limit

45

years-old

>

Gender

Male and Female

Key inclusion criteria

1)Age: 30 and over, below 45
2)Sex: Males and females with Japanese nationality
3)No exercise habit in the last 12 months
*Those who exercise once a week or less, or 2 to 3 times a month will be accepted.

Key exclusion criteria

1)Currently in treatment with medication or seeing a doctor for treatment
2)Previous history of hepatic disorder or severe disorder related to kidney, endocrine, cardiovascular system, gastro-intestine, lung, blood, or metabolism, or currently presence of complications
3)Previous history of drug allergy or food allergy
4)Regular intake of a food product or a supplement with a possible effect on relieving fatigue
5)Regular intake of medication with a possible effect on relieving fatigue
6)Extreme faddiness
7)Extremely irregular lifestyle such as a dietary pattern and a sleeping pattern
8)Suspicion of insomnia
9)Presence or previous history of mental disorder (depression, etc.)
10)Presence or previous history of alcoholism
11)Current participation in another clinical trial or participation in another clinical trial within the last three months
12)Irregular work hours such as working on night shift
13)Exercise habit (twice a week or more)
14)Determined by the investigator to be unsuitable for enrollment in this study

Target sample size

26

Name of lead principal investigator

1st name
Middle name
Last name	Takihara Takanobu

Organization

ITO EN, Ltd.

Division name

Central Research Institute

Zip code

Address

21 Mekami, Makinohara-shi, Shizuoka 421-0516, Japan

TEL

0548-54-1247

Email

t-takihara@itoen.co.jp

Name of contact person

1st name
Middle name
Last name	Ochitani Daisuke

Organization

HUMA R&D CORP

Division name

Clinical Development Division

Zip code

Address

Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan

TEL

81-3-3431-1260

Homepage URL

Email

ochitani@huma-c.co.jp

Institute

HUMA R&D CORP

Institute

Department

Personal name

Organization

ITO EN, LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

01

Month

23

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

2017

Year

12

Month

08

Day

Date of IRB

Anticipated trial start date

2018

Year

02

Month

04

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

01

Month

19

Day

Last modified on

2018

Year

07

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035268