UMIN-CTR Clinical Trial

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
Institute	CPCC Company Limited
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043467