UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025643 |
|---|---|
| Receipt number | R000029504 |
| Scientific Title | Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the effects of resveratrol dimer from melinjo (Gnetum gnemon) on the adiponectin and its-related molecules among healthy adult males |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2019/03/12 09:56:21 |
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Basic information
Public title
Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the effects of resveratrol dimer from melinjo (Gnetum gnemon) on the adiponectin and its-related molecules among healthy adult males
Acronym
Comparative study to evaluate the efficacy of melinjo among healthy volunteer
Scientific Title
Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the effects of resveratrol dimer from melinjo (Gnetum gnemon) on the adiponectin and its-related molecules among healthy adult males
Scientific Title:Acronym
Comparative study to evaluate the efficacy of melinjo among healthy volunteer
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the effect of melinjo on thedisulfide bond-forming oxidoreductase A-Like protein (DsbA-L) by administration of melinjo or placebo to healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The effects of melinjo seed extract administration for 2 weeks on the DsbA-L activity
Key secondary outcomes
DsbA-L mRNA
PPAR activity and mRNA
Adiponectin activity
HMW adiponectin activity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Melinjo 300mg group:
Melinjo at 300mg/day (melinjo tablet 150mg 2 tablet with single daily dosing during 2 weeks)
Interventions/Control_2
Melinjo 150mg group:
Melinjo at 150mg/day (melinjo tablet 75mg 2 tablet with single daily dosing during 2 weeks)
Interventions/Control_3
Placebo group:
Melinjo at 0mg/day (placebo tablet 2 tablet with single daily dosing during 2weeks)
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
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy, non-smoking Japanese
male volunteers
Key exclusion criteria
1) An allergy to melinjo and any medicine or food
2) A history of any infectious disease with in 4 weeks before enrolment
3) The use of any investigational drugs within 3 months
4) The use of melinjo or medicines within
2 weeks before enrolment
5) The use of prescription or over-the-counter medications or alcohol within 2 days before enrolment
6) Consumption of functional foods related to lipid and glucose metabolism
7) Regularly drinking red wine
8) Preexisting liver, renal, lung, gastrointestinal tract or heart disease
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Oniki |
Organization
Graduate School of Pharmaceutical Sciences, Kumamoto University
Division name
Division of Pharmacology and Therapeutics
Zip code
8620973
Address
5-1 Oe-honmachi, Chuo-ku, Kumamoto 862-0973, Japan
TEL
096-371-4512
oniken@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Oniki |
Organization
Graduate School of Pharmaceutical Sciences, Kumamoto University
Division name
Division of Pharmacology and Therapeutics
Zip code
8620973
Address
5-1 Oe-honmachi, Chuo-ku, Kumamoto 862-0973, Japan
TEL
096-371-4512
Homepage URL
oniken@kumamoto-u.ac.jp
Sponsor or person
Institute
Division of Pharmacology and Therapeutics, Graduate School of Pharmaceutical Sciences, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
The study was supported by grants-in-aid for scientific research from the Ministry of Education, Culture, Sports, Science and Technology, and from the Yamada Research Grant.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethics committee of the Faculty of Life Sciences, Kumamoto University
Address
1-1-1 Honjo, Chuo-ku, Kumamoto
Tel
096-373-5797
ski-shien@jimu.kumamoto-u.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
| 2017 | Year | 04 | Month | 01 | 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 | 01 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 12 | Day |
Last modified on
| 2019 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029504
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| Registered date | File name |
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