UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033748
Receipt number R000038489
Scientific Title A study to evaluate effects of test food on physical performance and fatigue during exercise
Date of disclosure of the study information 2018/09/12
Last modified on 2019/02/13 11:03:25

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Basic information

Public title

A study to evaluate effects of test food on physical performance and fatigue during exercise

Acronym

A study to evaluate effects of test food on physical performance and fatigue during exercise

Scientific Title

A study to evaluate effects of test food on physical performance and fatigue during exercise

Scientific Title:Acronym

A study to evaluate effects of test food on physical performance and fatigue during exercise

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate effects of test food on physical exercise and fatigue.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Maximal oxygen consumption (VO2 max)
Questionnaire on fatigue

Key secondary outcomes

Ventilation threshold
Rating of perceived exertion
Physical performance
Blood biochemistry
Muscle mass
Body fat mass
Intestinal microbiome


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

Prevention

Type of intervention

Food

Interventions/Control_1

Intake 3 tablets of active food 1 daily for 9 weeks.

Interventions/Control_2

Intake 3 tablets of active food 2 daily for 9 weeks.

Interventions/Control_3

Intake 3 tablets of placebo food daily for 9 weeks.

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

20 years-old <=

Age-upper limit

49 years-old >=

Gender

Male

Key inclusion criteria

1)Males aged 20-49 years.
2)Subjects who have exercise habits once or twice a week.
3)Subjects who can continue with the exercise habits during test period.
4)Subjects who don't take prohibited foods such as dietary supplements for exercise and can keep it during test period.
5)Subjects who show understanding of the clinical study procedures and agreement with participating the study by written informed consent.

Key exclusion criteria

1)Subjects who have consciousness of being constipation or diarrhea.
2)Subjects who have previous and/or current medical history of serious disease in heart, liver, kidney, or digestive system.
3)Subjects who drink alcohol a lot.
4)Subjects who have extremely irregular dietary habits or life rhythm.
5)Subjects who have allergy to medicines or foods.
6)Subjects who are participating the other clinical test, were participating it within the past 4 weeks, or are going to participate it.
7)Subjects who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
8)Subjects judged as unsuitable for the study by the principal or attending investigator.

Target sample size

36


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Suguru Fujiwara

Organization

CPCC Company Limited

Division name

Clinical Research Planning Department

Zip code


Address

4F Chushin Building, 3-3-5 Uchikanda, Chiyoda-ku, Tokyo 101-0047, Japan

TEL

03-5297-3112

Email

cpcc-contact@cpcc.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masanori Numa

Organization

CPCC Company Limited

Division name

Plan Sales Department

Zip code


Address

4F Chushin Building, 3-3-5 Uchikanda, Chiyoda-ku, Tokyo 101-0047, Japan

TEL

03-5297-3112

Homepage URL


Email

cpcc-contact@cpcc.co.jp


Sponsor or person

Institute

CPCC Company Limited

Institute

Department

Personal name



Funding Source

Organization

Asahi Group Holdings, 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


Address


Tel


Email



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

2018 Year 09 Month 12 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

2018 Year 08 Month 10 Day

Date of IRB


Anticipated trial start date

2018 Year 09 Month 13 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 08 Month 14 Day

Last modified on

2019 Year 02 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038489


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name