UMIN-CTR Clinical Trial

Basic information
Public title	Effects of carotenoid on exercise performance.
Acronym	Effects of carotenoid on exercise performance.
Scientific Title	Effects of carotenoid on exercise performance.
Scientific Title:Acronym	Effects of carotenoid on exercise performance.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare and investigate the exercise effect before and after the consumption of a test food in the 8 week, using placebo as the control.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Respiratory metabolism(oxygen consumption, carbon dioxide exhaustion, minute ventilation, breathing exchange ratio)
Key secondary outcomes	Body composition Heart rate Rate of Perceived Exertion Antioxidative activity(BAP) and Oxidant stress(d-ROMs) in plasma Carotenoids composition in blood Lactic acid in blood Urinary 8-OHdG Urinary isoprostane Dietary survey Visual analog scale of fatigue

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	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Soft capsule Once a day for 8weeks
Interventions/Control_2	Placebo soft capsule Once a day for 8weeks
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	30 years-old >
Gender	Male
Key inclusion criteria	(1)Healthy adults (2) The male college student aged >= 20 years (3)Those who has an exercise habit. (4)Those who adequately understand the objective and details of this study, and give written informed consent.
Key exclusion criteria	(1)Those who has a smoking habit. (2)Those who routinely take supplements that contain the same components as the test food. (3) Those who are receiving the treatments to treat or prevent disease at medical institution at the time of receiving informed consent, or who have need of those therapy. (4) Those who have serious disorders of carbohydrate metabolism, lipid metabolism, liver function, kidney function, heart, cardiovascular, respiratory organs, endocrine system and nervous system, or with a history of psychiatric disorder. (5) Those with a history of alcoholic and drug dependency. (6) Those with allergies to foods. (7) Those who have participated in other human studies within the past 4 weeks, or who plan to participate. (8)Those judges inadequate to enroll in the study at the discretion of the principal investigator.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Mikako Sunaga
Organization	Nippon Sport Science University
Division name	School of childhood sport education
Zip code
Address	7-1-1 Fukasawa, Setagaya-ku, Tokyo
TEL	03-5706-1360
Email	sunaga@nittai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Mikako Sunaga
Organization	Nippon Sport Science University
Division name	School of childhood sport education
Zip code
Address	7-1-1 Fukasawa, Setagaya-ku, Tokyo
TEL	03-5706-1360
Homepage URL
Email	sunaga@nittai.ac.jp

Sponsor
Institute	Nippon Sport Science University
Institute
Department

Funding Source
Organization	Glico Nutrition Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Ezaki Glico Co., Ltd.
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	日本体育大学　東京・世田谷キャンパス（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 28 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	No longer recruiting
Date of protocol fixation	2017 Year 05 Month 11 Day
Date of IRB
Anticipated trial start date	2017 Year 07 Month 28 Day
Last follow-up date	2017 Year 10 Month 30 Day
Date of closure to data entry	2017 Year 11 Month 20 Day
Date trial data considered complete	2017 Year 11 Month 20 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 07 Month 18 Day
Last modified on	2017 Year 12 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032357

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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