UMIN-CTR Clinical Trial

Basic information
Public title	Effect of peanut ingestion on endurance performance
Acronym	Peanut ingestion and endurance performance
Scientific Title	Examination of the effect of peanut consumption on exercise function
Scientific Title:Acronym	Peanut ingestion and exercise function
Region	Japan

Condition
Condition	Normal subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of peanut ingestion on endurace performance.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Workload
Key secondary outcomes	Heart rate 8-hydroxy-2'-deoxyguanosine (8-OHdG)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Food Behavior,custom
Interventions/Control_1	Ingestion of a beverage consisting of 30 g of peanuts mixed with 150 g of water. After 2 hours of ingestion, 70 minutes of pedaling exercise.
Interventions/Control_2	Ingestion of 180g of water. After 2 hours of ingestion, 70 minutes of pedaling exercise.
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	25 years-old >=
Gender	Female
Key inclusion criteria	1)Japanese 2) Subjects with no peanut allergy 3) Subjects agrees to participate in the experiment
Key exclusion criteria	None of subjects were suffering from hip, knee or ankle joint pain.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Morimasa Middle name Last name Kato
Organization	Yamagata Prefectural Yonezawa University of Nutrition Sciences
Division name	Department of Health and Nutrition
Zip code	992-0025
Address	6-15-1 Tori-machi, Yonezawa, Yamagata, Japan
TEL	81-238-22-7375
Email	m-kato@yone.ac.jp

Public contact
Name of contact person	1st name Morimasa Middle name Last name Kato
Organization	Yamagata Prefectural Yonezawa University of Nutrition Sciences
Division name	Department of Health and Nutrition
Zip code	992-0025
Address	6-15-1 Tori-machi, Yonezawa, Yamagata, Japan
TEL	81-238-22-7375
Homepage URL
Email	m-kato@yone.ac.jp

Sponsor
Institute	Yamagata Prefectural Yonezawa University of Nutrition Sciences
Institute
Department

Funding Source
Organization	Denroku Co Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yamagata Prefectural Yonezawa University of Nutrition Sciences
Address	6-15-1 Tori-machi, Yonezawa, Yamagata, Japan
Tel	81-238-22-7375
Email	m-kato@yone.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

Other administrative information
Date of disclosure of the study information	2021 Year 06 Month 07 Day

Related information
URL releasing protocol	https://www.hindawi.com/journals/ecam/2022/3757395/
Publication of results	Published

Result
URL related to results and publications	https://www.hindawi.com/journals/ecam/2022/3757395/
Number of participants that the trial has enrolled	12
Results	High oleic peanut ingestion significantly increased endurance exercise capacity compared to control condition. High oleic peanut ingestion significantly decreased the post-exercise increase rate of urinary 8-OHdG, a biomarker of oxidative stress, compared to the control condition.
Results date posted	2022 Year 09 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	normal subject
Participant flow	Open Recruiting
Adverse events	None
Outcome measures	Workload Heart rate Urinary 8-OHdG
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 01 Day
Date of IRB	2016 Year 12 Month 01 Day
Anticipated trial start date	2016 Year 12 Month 01 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 06 Month 06 Day
Last modified on	2022 Year 09 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050779