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UMIN-CTR Clinical Trial |
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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 | 2020/07/21 |
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 |
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Condition | ||
Condition | Healthy adults | |
Classification by specialty |
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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 |
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Interventions/Control_1 | Soft capsule
Once a day for 8weeks |
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Interventions/Control_2 | Placebo soft capsule
Once a day for 8weeks |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | 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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |