UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028271
Receipt No. R000032357
Scientific Title Effects of carotenoid on exercise performance.
Date of disclosure of the study information 2017/07/28
Last modified on 2017/12/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.