UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027178 |
|---|---|
| Receipt number | R000031141 |
| Scientific Title | Comprehensive study on the health promotion effect by continuous ingestion of peanuts for 8 weeks |
| Date of disclosure of the study information | 2017/04/28 |
| Last modified on | 2017/07/25 09:08:06 |
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Basic information
Public title
Comprehensive study on the health promotion effect by continuous ingestion of peanuts for 8 weeks
Acronym
Comprehensive study on the health promotion effect by continuous ingestion of peanuts for 8 weeks
Scientific Title
Comprehensive study on the health promotion effect by continuous ingestion of peanuts for 8 weeks
Scientific Title:Acronym
Comprehensive study on the health promotion effect by continuous ingestion of peanuts for 8 weeks
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine comprehensively about the health promotion effect of continuous ingestion of peanuts against healthy adult women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Obesity related factor
Key secondary outcomes
Self-aware questionnaire, blood test (general biochemical test), blood oxidative stress marker, blood glycation marker, urine putrid substance, intestinal flora
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingest peanuts 27.5 g/day for 8 continuous weeks
Interventions/Control_2
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2. Healthy Japanese women who is 30 years old or more and less than 60 years old
3. Persons whose BMI is 23 or more
Key exclusion criteria
1. Persons with the severe disease medical history
2. Persons who are allergic to the test food
3. Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
4. Persons who are pregnant, breastfeeding, planning or hoping to be pregnant during the study period
5. Persons who were judged as inappropriate for subjects by the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Osawa |
Organization
Aichi Gakuin University
Division name
Department of Health and Nutrition
Zip code
Address
12 Araike, Iwasaki-cho, Nisshin-shi, Aichi, Japan
TEL
0561-73-1111
osawat@dpc.aichi-gakuin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirohito Ishikawa |
Organization
Healthcare Systems Co., Ltd.
Division name
Research and Development
Zip code
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
ishikawa@hc-sys.jp
Sponsor or person
Institute
Denroku Co., Ltd.
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
Healthcare Systems Co., Ltd.
Aichi Gakuin University
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
| 2017 | Year | 04 | Month | 28 | 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
| 2017 | Year | 04 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 28 | Day |
Last modified on
| 2017 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031141
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
