UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023813 |
|---|---|
| Receipt number | R000027434 |
| Scientific Title | The study on the effects of oleic acid rich peanut product on serum lipid: a double-blind, randomized controlled trial. |
| Date of disclosure of the study information | 2016/08/31 |
| Last modified on | 2017/09/13 16:24:22 |
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Basic information
Public title
The study on the effects of oleic acid rich peanut product on serum lipid: a double-blind, randomized controlled trial.
Acronym
The effects of oleic acid rich peanut product on serum lipid.
Scientific Title
The study on the effects of oleic acid rich peanut product on serum lipid: a double-blind, randomized controlled trial.
Scientific Title:Acronym
The effects of oleic acid rich peanut product on serum lipid.
Region
| Japan |
Condition
Condition
hyperlipidemia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the effects of oleic acid rich peanut product on serum lipid levels in subjects with mild hyperlipidemia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum lipids
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingesting 40g of peanut product daily for 8 weeks
Interventions/Control_2
Ingesting 40g of oleic acid rich peanut product daily for 8 weeks
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
| 50 | years-old | <= |
Age-upper limit
| 76 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) subjects fulfilling at least one of the following criteria
199<TC<260mg/dL
149<TG<400 mg/dL
119<LDL-C<180 mg/dL
(2) Subjects who are not prescribed drug for hyperlipidemia.
Key exclusion criteria
(1)Subject who is prescribed drug.
(2)Subject who suffers or suffered from severe cardiovascular, hepatic, renal, pulmonary, endocrine, or metabolic disorder.
(3)Subject who experienced chest pain or syncope.
(4)Subject who has allergy to test food.
(5)Subject who donated whole blood ,200ml within 1 month or 400ml within 3 month, before entry.
(6)Smokers
(7)Subjects who participate in other clinical trials within the last 3 month before entry.
(8)Subjects who are not eligible due to physician's judgment
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Suzuki |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
Address
1-1, Hiragagakuendai, Inzai, Chiba, 270-1695 Japan
TEL
+81-476-98-1001
yssuzuki@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshio Suzuki |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
Address
1-1, Hiragagakuendai, Inzai, Chiba, 270-1695 Japan
TEL
+81-476-98-1001
Homepage URL
yssuzuki@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University, Graduate School of Health & Sports Science
Institute
Department
Personal name
Funding Source
Organization
Chiba Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
1. Kazusa DNA Research Institute Chiba Prefectural Agriculture
2. Forestry Research Center
3. Yachimata Peanuts Commerce and Industry Cooperative
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 08 | Month | 31 | 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
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
| 2016 | Year | 07 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 29 | Day |
Last modified on
| 2017 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027434
