UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044447 |
|---|---|
| Receipt number | R000050779 |
| Scientific Title | Examination of the effect of peanut consumption on exercise function |
| Date of disclosure of the study information | 2021/06/07 |
| Last modified on | 2022/09/15 14:23:37 |
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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
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
m-kato@yone.ac.jp
Sponsor or person
Institute
Yamagata Prefectural Yonezawa University of Nutrition Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050779
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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