UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030364
Receipt number 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 12:09:06

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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 or person

Institute

Aichi Medical University

Institute

Department

Personal name



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

Value
https://center6.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