UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038134
Receipt number R000043467
Scientific Title A confirmation test of fatigue feeling decreasing effect after exercise loading by test food consumption
Date of disclosure of the study information 2020/10/01
Last modified on 2020/10/09 11:59:29

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Basic information

Public title

A confirmation test of fatigue feeling decreasing effect after exercise loading by test food consumption

Acronym

A confirmation test of fatigue feeling decreasing effect after exercise loading by test food consumption

Scientific Title

A confirmation test of fatigue feeling decreasing effect after exercise loading by test food consumption

Scientific Title:Acronym

A confirmation test of fatigue feeling decreasing effect after exercise loading by test food consumption

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm decreasing effect of fatigue feeling after exercise loading by test food consumption.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1.Visual Analog Scale questionnaire of fatigue feeling (before exercise load, just after exercise load finished, 30 min after exercise load finished, 60 min after exercise load finished and a day after exercise load finished)
2.Blood biochemical test (CPK)
3.Plasma TGF-beta concentration

Key secondary outcomes

1.Plasma cytokine concentration (IL-6, TNF-alfa)
2.NK-cell activity
3.Blood amino acid concentration (Gln, BCAA, Trp)
4.Blood biochemical test (AST, ALT, LDH, gamma-GTP, BUN, CRE)
5.Borg scale questionnaire (before exercise load, just after exercise load finished)
6.POMS short version (before exercise load, 60 min after exercise load finished)
7.Incidence rate of adverse events and side effects
8.Others (body weight, BMI, blood pressure and systolic blood pressure, diastolic blood pressure and pulse rate)


Base

Study type

Interventional


Study design

Basic design

Cross-over

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

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake 2 packages of test food a day for 8 days. Rest 4 weeks. Intake 2 packages of control food a day for 8 days.

Interventions/Control_2

Intake 2 packages of control food a day for 8 days. Rest 4 weeks. Intake 2 packages of test food a day for 8 days.

Interventions/Control_3


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

65 years-old >

Gender

Male and Female

Key inclusion criteria

(1) Males and females of Japanese aged 20 to 64 years old.
(2) Subjects who don't have exercise habituation on a daily basis.
(3) Subjects who receive enough explain of the test, who deeply understanding of the test, and who obtain own consent to participate the test.

Key exclusion criteria

Subjects who
1)are given continuous treatment by taking medicines.
2)ingest food for specified health use, functional foods, health foods and supplements (rich containing proteins, peptides and/or amino acids) more than 3 days a week.
3)use medicines that possibly have the influence for fatigue feeling more than 3 days a week. Subjects who ingest food for specified health use, functional foods, health foods and/or supplements those possibly have the influence for fatigue feeling more than 3 days a week.
4)are pregnant or lactating, and females who could become pregnant or lactating during test period.
5)have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ) containing history of surgical operations.
6)excessive alcohol intake.
7)smoke
8)have extremely irregular dining habits, and subjects who have midnight work or irregular shift work.
9)have previous medical history of drug and/or food allergy (especially to wheat and/or to soy bean).
10)are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
11)donated over 200mL blood and/or blood components within the last one month to the current study.
12)donated over 400mL blood and/or blood components within the last three month to the current study.

And
13)Females who donated over 400mL blood and/or blood components within the last four month to the current study.
14)Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
15)Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
(16)Others who have been determined ineligible by principal investigator or sub-investigator.


Target sample size

20


Research contact person

Name of lead principal investigator

1st name Hiroyuki
Middle name
Last name Ikemoto

Organization

NISSHIN PHARMA INC.

Division name

HEALTH CARE RESEARCH CENTER

Zip code

356-8511

Address

5-3-1, Tsurugaoka, Fujimino-city, Saitama 356-8511, Japan

TEL

049-267-3940

Email

ikemoto.hiroyuki@nisshin.com


Public contact

Name of contact person

1st name Masanori
Middle name
Last name Numa

Organization

CPCC Company Limited

Division name

Planning and Sales Department

Zip code

101-0047

Address

4F Sanwauchikanda 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

NISSHIN PHARMA INC.

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

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan

Tel

03-5297-5548

Email

IRB@cpcc.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

2020 Year 10 Month 01 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 09 Month 24 Day

Date of IRB

2019 Year 09 Month 20 Day

Anticipated trial start date

2019 Year 10 Month 01 Day

Last follow-up date

2019 Year 12 Month 04 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 09 Month 27 Day

Last modified on

2020 Year 10 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043467


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name