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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030364
Receipt No. R000034668
Scientific Title Study to evaluate NK cell and antioxidant potentiating effect by supplement Gnetin C resveratrol
Date of disclosure of the study information 2017/12/12
Last modified on 2019/06/25

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Basic information
Public title Study to evaluate NK cell and antioxidant potentiating effect by supplement Gnetin C resveratrol
Acronym Effect of Gnetin C resveratrol on NK cell and antioxidant function
Scientific Title Study to evaluate NK cell and antioxidant potentiating effect by supplement Gnetin C resveratrol
Scientific Title:Acronym Effect of Gnetin C resveratrol on NK cell and antioxidant function
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effectiveness and safety of supplement Gnetin C resveratrol, we investigate kinetics of NK cell, antioxidant, lipid, and uric acid functions before and after oral administration of Gnetin C resveratrol or placebo as well as the safety profiles using healthy volunteers.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Influence of oral administration of Gnetinc C resveratrol on the expression of NK related antigens and NK cell function during 4 weeks after its start
Key secondary outcomes Gnetin C resveratrol related toxicity during 4 weeks after its oral administration
Influence of oral administration of Gnetin C resveratrol on the serum and urine antioxidant function and uric acid metabolism functionduring 4 weeks after its start

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 NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Ingestion of 150 mg Gnetinc C resveratrol daily for 2 weeks
Interventions/Control_2 Ingestion of 150 mg placebo daily for 2 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
20 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria Drinking three times or less a week, normal liver and renal function that has been confirmed in a medical examination within one year, and consent by explanation and agreement documents.
Key exclusion criteria Any of the following: currently receiving a drug therapy, currently having chronic diseases such as heart, lung, kidney, gastrointestinal, and inflammatory diseases, suffering from invasive cancer within five years, suffering from non-invasive cancer within a year, a history of smoking within one year, taking foods which contain resveratrol, supplements, vitamins within 2 weeks, pregnant or lactating, and a history of hypersensitivity to resveratrol or supplements including resveratrol.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Akiyoshi
Middle name
Last name Takami
Organization Aichi Medical University School of Medicine
Division name Division of Hematology, Department of Internal Medicine
Zip code 480-1195
Address 1-1 Yazakokarimata, Nagakute, Japan 480-1195
TEL 0561-62-3311
Email takami-knz@umin.ac.jp

Public contact
Name of contact person
1st name Akiyoshi
Middle name
Last name Takami
Organization Aichi Medical University School of Medicine
Division name Division of Hematology, Department of Internal Medicine
Zip code 480-1195
Address 1-1 Yazakokarimata, Nagakute, Japan 480-1195
TEL 0561-62-3311
Homepage URL
Email takami-knz@umin.ac.jp

Sponsor
Institute Aichi Medical University
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports and Technology of Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Aichi Medical University Hospital Ethics Committee
Address 1-1 Yazakokarimata, Nagakute, Japan 480-1195
Tel 0561-62-3311
Email amu_ethics@aichi-med-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 愛知医科大学病院(愛知県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 12 Day

Related information
URL releasing protocol https://www.mdpi.com/2072-6643/11/6/1403/htm
Publication of results Published

Result
URL related to results and publications https://www.mdpi.com/2072-6643/11/6/1403/htm
Number of participants that the trial has enrolled 12
Results All subjects completed the study, with no side effects reported across the study duration. Gnetin-C supplementation demonstrated a statistically significant increase in the absolute number of circulating natural killer (NK) cells expressing the activating receptors NKG2D and NKp46. NK cells derived from subjects who received Gnetin-C for two weeks showed higher cytotoxicity against K562 target cells than those before receiving Gnetin-C.
Results date posted
2019 Year 06 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 06 Month 21 Day
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 12 Month 12 Day
Date of IRB
2017 Year 12 Month 14 Day
Anticipated trial start date
2018 Year 01 Month 04 Day
Last follow-up date
2018 Year 06 Month 30 Day
Date of closure to data entry
2018 Year 07 Month 11 Day
Date trial data considered complete
2018 Year 07 Month 11 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 12 Month 12 Day
Last modified on
2019 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034668

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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