UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028271 |
|---|---|
| Receipt number | R000032357 |
| Scientific Title | Effects of carotenoid on exercise performance. |
| Date of disclosure of the study information | 2017/07/28 |
| Last modified on | 2022/07/22 10:45:55 |
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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 | Mikako |
| Middle name | |
| Last name | Sunaga |
Organization
Nippon Sport Science University
Division name
School of childhood sport education
Zip code
158-8508
Address
7-1-1 Fukasawa, Setagaya-ku, Tokyo
TEL
03-5706-1360
sunaga@nittai.ac.jp
Public contact
Name of contact person
| 1st name | Mikako |
| Middle name | |
| Last name | Sunaga |
Organization
Nippon Sport Science University
Division name
School of childhood sport education
Zip code
158-8508
Address
7-1-1 Fukasawa, Setagaya-ku, Tokyo
TEL
03-5706-1360
Homepage URL
sunaga@nittai.ac.jp
Sponsor or person
Institute
Nippon Sport Science University
Institute
Department
Personal name
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
Nippon Sport Science University, Research Review Board
Address
7-1-1 Fukasawa, Setagaya-ku, Tokyo
Tel
03-5706-0931
souspo@nittai.ac.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
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
https://www.itmedicalteam.pl/articles/effects-of-orally-ingested-paprikaxanthophylls-on-respiratory-
Publication of results
Published
Result
URL related to results and publications
https://www.itmedicalteam.pl/articles/effects-of-orally-ingested-paprikaxanthophylls-on-respiratory-
Number of participants that the trial has enrolled
21
Results
The ingestion of paprika xanthophylls may improve energy efficiency during endurance exercise.
Results date posted
| 2022 | Year | 07 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The participants were 21 male university student athletes (six rubber-ball baseball players, six short-distance track and field athletes, four racing cyclists, two lacrosse players, two cheerleaders, and one speed skater). All participants habitually exercised 5 or more days a week, and did not smoke.
Participant flow
Compliance with the rules for research using human subjects, protection of personal data, and the ethical considerations of the present study were approved by the relevant ethics review committee. In accordance with the Declaration of Helsinki, all participants were provided verbal and written explanations of the ethical considerations of the study, and provided their written, informed consent to participate.
Adverse events
No adverse events occurred from this study.
Outcome measures
1.Maximal oxygen consumption
2.Respiratory gas analysis
3.Blood carotenoid analysis
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 11 | Day |
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
| 2022 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032357
