UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000007690
Receipt No. R000009070
Scientific Title Phase I study to evaluate the safety and efficacy of resveratrol in enhancing the function of natural killer cells
Date of disclosure of the study information 2012/04/09
Last modified on 2019/06/21 (Ver. 6)

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Basic information
Public title Phase I study to evaluate the safety and efficacy of resveratrol in enhancing the function of natural killer cells
Acronym Safety and efficacy of resveratrol in enhancing NK activity
Scientific Title Phase I study to evaluate the safety and efficacy of resveratrol in enhancing the function of natural killer cells
Scientific Title:Acronym Safety and efficacy of resveratrol in enhancing NK activity
Region
Japan

Condition
Condition immune insufficiency, hematologic malignancy, solid tumor
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Pneumology Endocrinology and Metabolism Hematology and clinical oncology
Nephrology Neurology Clinical immunology
Infectious disease Geriatrics Surgery in general
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery
Endocrine surgery Breast surgery Obsterics and gynecology
Pediatrics Ophthalmology Dermatology
Psychiatry Oto-rhino-laryngology Orthopedics
Urology Oral surgery Adult
Child
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of the supplement resveratrol in influencing the function of natural killer cells, oral supplements including resveratrol are given to healthy individuals and kinetic change is investigated.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Resveratrol related toxicity during 12 weeks after the start of oral administration of resveratrol
Key secondary outcomes Influence of resveratrol in the expression of NK related receptors on NK cells.
Influence of resveratrol in the NK cell activity.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intake period of Transmax resveratrol, 28 days; observation period, 15 days; control period, 42 days
Interventions/Control_2 Control period, 42 days; intake period of Transmax resveratrol, 28 days; observation period, 15 days;
Interventions/Control_3 Intake period of Melinjo resveratrol, 28 days; observation period, 15 days; control period, 42 days
Interventions/Control_4 Control period, 42 days; intake period of Melinjo resveratrol, 28 days; observation period, 15 days;
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 No subjective symptom, drinking three times or less a week, and normal liver and renal function that has been confirmed in a medical examination within one year.
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, and a history of smoking within one year.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Akiyoshi
Middle name
Last name Takami
Organization Kanazawa University Hospital
Division name Division of Transfusion Medicine and Department of Hematology and Oncology
Zip code 920-8641
Address 13-1 Takaramachi, Kanazawa, Japan 920-8641
TEL 076-265-2017
Email takami-knz@umin.ac.jp

Public contact
Name of contact person
1st name Akiyoshi
Middle name
Last name Takami
Organization Kanazawa University Hospital
Division name Division of Transfusion Medicine and Department of Hematology and Oncology
Zip code 920-8641
Address 13-1 Takaramachi, Kanazawa, Japan 920-8641
TEL 076-265-2017
Homepage URL
Email takami-knz@umin.ac.jp

Sponsor
Institute Kanazawa University Hospital
Institute
Department

Funding Source
Organization A grant from 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 Kanazawa University Hospital
Address 13-1 Takaramachi, Kanazawa, Japan 920-8641
Tel 076-265-2043
Email nagase@staff.kanazawa-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 金沢大学病院（石川県）

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 09 Day

Related information
URL releasing protocol https://www.oatext.com/Stilbene-derivatives-from-melinjo-extract-have-antioxidant-and-immune-modulat
Publication of results Published

Result
URL related to results and publications https://www.oatext.com/Stilbene-derivatives-from-melinjo-extract-have-antioxidant-and-immune-modulat
Number of participants that the trial has enrolled 5
Results 
The administration of MES resulted in a significant increase in the antioxidant activity of the plasma and a decrease in the protein carbonyl content of the plasma compared with the corresponding baseline levels. The circulating numbers of B and T lymphocytes remained essentially unchanged throughout the course of the study, however MES consumption was associated with an increase in the proportion of circulating NK cells and regulatory T cells (CD3+, CD4+, CD25, CD127low/neg).
Results date posted
2019 Year 06 Month 21 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2015 Year 11 Month 05 Day
Baseline Characteristics 
This study evaluated the cellular and molecular immune responses in 5 healthy volunteers at baseline and after the oral administration of MSE for 28 days.
Participant flow 
The ethanol extract of Melinjo seeds (MSE), an edible fruit native to Southeast Asia, is rich in resveratrol dimer (gnetin C) and other stilbenes. In preclinical studies MES was shown to exert antioxidant, anti-inflammatory and other health promoting activities. This study evaluated the cellular and molecular immune responses in 5 healthy volunteers at baseline and after the oral administration of MSE for 28 days. The administration of MES resulted in a significant increase in the antioxidant activity of the plasma and a decrease in the protein carbonyl content of the plasma compared with the corresponding baseline levels. The circulating numbers of B and T lymphocytes remained essentially unchanged throughout the course of the study, however MES consumption was associated with an increase in the proportion of circulating NK cells and regulatory T cells (CD3+, CD4+, CD25, CD127low/neg). In addition, MES-treated peripheral blood mononuclear cells more efficiently generated Treg cells in vitro compared with their un-treated counterparts. These findings demonstrate that MES modulates oxidative stress parameters in the plasma of healthy individuals and has biological effects on immune cells.
Adverse events 
The ethanol extract of Melinjo seeds (MSE), an edible fruit native to Southeast Asia, is rich in resveratrol dimer (gnetin C) and other stilbenes. In preclinical studies MES was shown to exert antioxidant, anti-inflammatory and other health promoting activities. This study evaluated the cellular and molecular immune responses in 5 healthy volunteers at baseline and after the oral administration of MSE for 28 days. The administration of MES resulted in a significant increase in the antioxidant activity of the plasma and a decrease in the protein carbonyl content of the plasma compared with the corresponding baseline levels. The circulating numbers of B and T lymphocytes remained essentially unchanged throughout the course of the study, however MES consumption was associated with an increase in the proportion of circulating NK cells and regulatory T cells (CD3+, CD4+, CD25, CD127low/neg). In addition, MES-treated peripheral blood mononuclear cells more efficiently generated Treg cells in vitro compared with their un-treated counterparts. These findings demonstrate that MES modulates oxidative stress parameters in the plasma of healthy individuals and has biological effects on immune cells.
Outcome measures 
The ethanol extract of Melinjo seeds (MSE), an edible fruit native to Southeast Asia, is rich in resveratrol dimer (gnetin C) and other stilbenes. In preclinical studies MES was shown to exert antioxidant, anti-inflammatory and other health promoting activities. This study evaluated the cellular and molecular immune responses in 5 healthy volunteers at baseline and after the oral administration of MSE for 28 days. The administration of MES resulted in a significant increase in the antioxidant activity of the plasma and a decrease in the protein carbonyl content of the plasma compared with the corresponding baseline levels. The circulating numbers of B and T lymphocytes remained essentially unchanged throughout the course of the study, however MES consumption was associated with an increase in the proportion of circulating NK cells and regulatory T cells (CD3+, CD4+, CD25, CD127low/neg). In addition, MES-treated peripheral blood mononuclear cells more efficiently generated Treg cells in vitro compared with their un-treated counterparts. These findings demonstrate that MES modulates oxidative stress parameters in the plasma of healthy individuals and has biological effects on immune cells.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 12 Month 01 Day
Date of IRB
2012 Year 04 Month 01 Day
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
2013 Year 06 Month 01 Day
Date trial data considered complete
2013 Year 06 Month 01 Day
Date analysis concluded
2014 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 04 Month 08 Day
Last modified on
2019 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009070