UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000041049 |
|---|---|
| Receipt number | R000046661 |
| Scientific Title | Effects of a lychee fruit-derived low-molecular form of polyphenol mixture (Oligonol) intake on maximum anoxic power during high-intensity exercise in athletes |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2020/06/25 15:05:13 |
* 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 a lychee fruit-derived low-molecular form of polyphenol mixture (Oligonol) intake on maximum anoxic power during high-intensity exercise in athletes
Acronym
Effects of a lychee fruit-derived low-molecular form of polyphenol mixture (Oligonol) intake on maximum anoxic power during high-intensity exercise in athletes
Scientific Title
Effects of a lychee fruit-derived low-molecular form of polyphenol mixture (Oligonol) intake on maximum anoxic power during high-intensity exercise in athletes
Scientific Title:Acronym
Effects of a lychee fruit-derived low-molecular form of polyphenol mixture (Oligonol) intake on maximum anoxic power during high-intensity exercise in athletes
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the power, heart rate, rate of perceived exertion, antioxidant capacity (BAP), oxidative stress level (d-ROMs), and blood lactate concentration during high-intensity exercise when athletes intake 200 mg of Oligonol for 7 days.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
To evaluate the mean and maximum power, oxidative stress-related indexes during high-intensity exercise after ingestion of Oligonol for 7 days compared with control
Key secondary outcomes
To evaluate the blood lactate concentration, rate of perceived exertion, subjective questionnaire, heart rate during high-intensity exercise after ingestion of Oligonol for 7 days compared with control
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
200 mg of Oligonol daily (100 mg each for breakfast and dinner) for 7 days
Interventions/Control_2
Oligonol non-ingestion
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
| 23 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy adult, men, athletes, non-smokers
Key exclusion criteria
Subjects using vitamins, nourishing tonics, herbal medicines, general cold remedies, etc.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Sugita |
Organization
Nippon Sport Science University
Division name
Faculty of Sport Science
Zip code
158-8508
Address
Fukasawa, Setagaya-ku, Tokyo, Japan
TEL
0357061148
m-sugita@nittai.ac.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Sugita |
Organization
Nippon Sport Science University
Division name
Faculty of Sport Science
Zip code
158-8508
Address
Fukasawa, Setagaya-ku, Tokyo, Japan
TEL
0357061148
Homepage URL
m-sugita@nittai.ac.jp
Sponsor or person
Institute
Nippon Sport Science University
Faculty of Sport Science
Institute
Department
Personal name
Funding Source
Organization
Amino Up Chemical Co., Ltd,
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Sport Science University
Address
Fukasawa, Setagaya-ku, Tokyo, 158-8508, Japan
Tel
0357061148
m-sugita@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（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | 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
10
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 | 05 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 09 | Day |
Last modified on
| 2020 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046661
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
