UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044446 |
|---|---|
| Receipt number | R000050778 |
| Scientific Title | Effect of peanut ingestion on blood lipids |
| Date of disclosure of the study information | 2021/06/07 |
| Last modified on | 2022/04/04 10:54:14 |
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Basic information
Public title
Effect of peanut ingestion on triglycerides and free fatty acids
Acronym
Peanut ingestion and triglycerides , free fatty acids
Scientific Title
Effect of peanut ingestion on blood lipids
Scientific Title:Acronym
Peanut ingestion and blood lipids
Region
| Japan |
Condition
Condition
Normal subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of peanut ingestion on blood lipid levels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Free fatty acid
Key secondary outcomes
Triglycerides
Total cholesterol
HDL cholesterol
LDL cholesterol
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single oral ingestion of 10 g of peanut, measurement points are pre, 2, 4, and 6 hours after ingestion
Interventions/Control_2
Single oral ingestion of 30 g of peanut, measurement points are pre, 2, 4, and 6 hours after 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
| 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
Subjects with impaired health due to blood collection
Target sample size
10
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
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
8
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
| 2013 | Year | 08 | Month | 11 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 02 | Month | 10 | Day |
Date analysis concluded
| 2022 | Year | 02 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 06 | Day |
Last modified on
| 2022 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050778
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
