UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007690 |
|---|---|
| Receipt number | 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 15:40:11 |
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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 | Obstetrics 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
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
takami-knz@umin.ac.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009070
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