UMIN-CTR Clinical Trial

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
Email	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
Email	m-sugita@nittai.ac.jp

Sponsor
Institute	Nippon Sport Science University Faculty of Sport Science
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046661