UMIN-CTR Clinical Trial

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
Last 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
Email	oniken@kumamoto-u.ac.jp

Public contact
1st 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
Email	oniken@kumamoto-u.ac.jp

Sponsor
Institute	Division of Pharmacology and Therapeutics, Graduate School of Pharmaceutical Sciences, Kumamoto University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029504