Protocol summary

Summary
Background: The aim of this study is to evaluate the efficacy of resveratrol (trans-3, 5, 4’-trihydroxystilbene, a polyphenol present in grapes) in comparison with the placebo on blood pressure in participants with pre- and stage-1 hypertension. Design and Methods:In a randomized, double blind, placebo-controlled study, 50 participants with pre-hypertension (diastolic blood pressure and systolic blood pressure, 80- 89 mmHg and 120-139 mmHg, respectively) and 50 participants with stage 1 hypertension (diastolic and systolic, 90-99 mmHg and 140-159 mmHg, respectively) will be assigned to sequence A or B to receive resveratrol (99% pure from BIOTIVIA LONGEVITY BIOCEUTICALS LLC Company, USA, in 500 mg capsules, twice daily for 4 weeks, orally) or placebo (500 mg neutral micro cellulose capsules, twice daily for 4 weeks) in a 2×2 cross-over design (4 weeks treatment-4 weeks washout-4 weeks treatment). The participants’ blood pressure will be recorded (the average of two times within 15 minute interval) every week during the study. The participants in the pre-hypertensive group will not have any medication, while those in the stage 1 hypertensive group will continue to receive their routine medications during the study. Blood samples will be taken from all groups and examined for various biochemical parameters.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201407078129N7
Registration date: 2014-08-15, 1393/05/24
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-08-15, 1393/05/24
Registrant information
Name
Ali Movahed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3332 4044
Email address
a.movahed@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Department of Research, Bushehr University of Medical Sciences
Expected recruitment start date
2015-09-20, 1394/06/29
Expected recruitment end date
2016-09-19, 1395/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of Resveratrol on hypertension, a randomized cross-over double- blinded placebo-controlled trial
Public title
Efficacy of resveratrol in patients with pre and first stage hypertension
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Pre-hypertensive(average of two times measurement with an interval of 15 minutes, diastolic and systolic blood pressure(80-89mmHg, 120-139 mmHg respectively) • Stage 1 hypertensive (average of two times measurement with an interval of 15 minutes (diastolic and systolic blood pressure 90-99 mmHg, 140-159 mmHg, respectively) • Male or Female • Age between 20 and 60-years • Ability to provide informed consent Exclusion Criteria:Approved or doubtful secondary hypertension; History of chronic or acute kidney Disease; History of heart failure; History of chronic or acute liver diseases; History of diabetes mellitus; History of prior cardiovascular events (Acute Myocardial Infarction, Cardiovascular diseases, Percutaneous Coronary Angioplasty or Coronary Artery Bypass Graft); Pregnancy or breast feeding;Blood arterial pressure >160/110
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Randomization: A stratified complete block randomization method will be used in this trial.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Bushehr University of Medical Sciences
Street address
Director of Research, Pardis site, Next to Salmon Farsi Hospital, Bushehr University of Medical Sciences
City
Bushehr
Postal code
751472537
Approval date
2014-07-07, 1393/04/16
Ethics committee reference number
B-93-4-16

Health conditions studied

1

Description of health condition studied
Hypertension
ICD-10 code
I10-I15
ICD-10 code description
High Blood pressure

Primary outcomes

1

Description
Diastolic and systolic blood pressure
Timepoint
once in a week during intervention period
Method of measurement
A sphygmomanometer and Stethoscope will be used to measure the blood pressure, once in a week, and average of two times within 15 minutes will be recorded.

2

Description
Added at 2015-04-16: Mean arterial pressure
Timepoint
Added at 2015-04-16: once in a week during intervention
Method of measurement
Added at 2015-04-16: systolic blood BP plus 2 times diastolic BP divided by 3

Secondary outcomes

1

Description
PTT
Timepoint
Before and after the first stage intervention, after one month washout and after one month of second stage intervention
Method of measurement
By Reputed kits

2

Description
SGOT
Timepoint
Before and after the first stage intervention, after one month washout and after one month of second stage intervention
Method of measurement
By Kits and ELISA method

3

Description
SGPT
Timepoint
Before and after the first stage intervention, after one month washout and after one month of second stage intervention
Method of measurement
By Kits and ELISA method

4

Description
GGT
Timepoint
Before and after the first stage intervention, after one month washout and after one month of second stage intervention
Method of measurement
By Kits and ELISA method

5

Description
ALP
Timepoint
Before and after the first stage intervention, after one month washout and after one month of second stage intervention
Method of measurement
By Kits and ELISA method

6

Description
TG
Timepoint
Before and after the first stage intervention, after one month washout and after one month of second stage intervention
Method of measurement
By Reputed kits

7

Description
Cholesterol
Timepoint
Before and after the first stage intervention, after one month washout and after one month of second stage intervention
Method of measurement
By Reputed kits

8

Description
LDL
Timepoint
Before and after the first stage intervention, after one month washout and after one month of second stage intervention
Method of measurement
By Reputed kits

9

Description
HDL
Timepoint
Before and after the first stage intervention, after one month washout and after one month of second stage intervention
Method of measurement
By Reputed kits

10

Description
Hematocrit
Timepoint
Before and after the first stage intervention, after one month washout and after one month of second stage intervention
Method of measurement
By Reputed kits

11

Description
Albumin
Timepoint
Before and after the first stage intervention, after one month washout and after one month of second stage intervention
Method of measurement
Auto-analyzer (Spectrophotometry)

12

Description
platelets
Timepoint
Before and after the first stage intervention, after one month washout and after one month of second stage intervention
Method of measurement
By bleeding time test

13

Description
PT
Timepoint
Before and after the first stage intervention, after one month washout and after one month of second stage intervention
Method of measurement
By reputed kits

14

Description
Added at 2015-03-15: Bilirubin
Timepoint
Added at 2015-03-15: Before and after the first stage intervention, after one month washout and after one mont of second intervention
Method of measurement
Added at 2015-03-15: Auto-analyzer

15

Description
Added at 2015-04-16: Angiotensin II
Timepoint
Added at 2015-04-16: Before and after the first stage intervention, after one month washout time and after one month of second stage intervention
Method of measurement
Added at 2015-04-16: By kits for ELISA method

16

Description
Added at 2015-04-16: Endothelin 1
Timepoint
Added at 2015-04-16: Before and after the first stage intervention, after one month washout time and after one month of second stage intervention
Method of measurement
Added at 2015-04-16: By kits for ELISA method

17

Description
Added at 2015-04-16: Nor-epinephrine
Timepoint
Added at 2015-04-16: Before and after the first stage intervention, after one month washout time and after one month of second stage intervention
Method of measurement
Added at 2015-04-16: By kits for ELISA method

18

Description
Added at 2015-04-16: TNF- α
Timepoint
Added at 2015-04-16: Before and after the first stage intervention, after one month washout time and after one month of second stage intervention
Method of measurement
Added at 2015-04-16: By kits for ELISA method

19

Description
Added at 2015-04-16: nitric oxide
Timepoint
Added at 2015-04-16: Before and after the first stage intervention, after one month washout and after one month of second stage intervention
Method of measurement
Added at 2015-04-16: By kits for ELISA method

20

Description
Added at 2015-04-16: Malondialdehyde-uRINARY ISOPROSTANE
Timepoint
Added at 2015-04-16: Before and after the first stage intervention, after one month washout time and after one month of second stage intervention
Method of measurement
Added at 2015-04-16: By kits for ELISA method

Intervention groups

1

Description
The intervention group, Resveratrol ,99% pure(500 mg twice a day) for a period of one month.
Category
Treatment - Drugs

2

Description
The Control group, placebo ( 500 mg neutral cellulose, twice a day) for a period of one month
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Bushehr University of Medical Sciences
Full name of responsible person
Ali Movahed
Street address
Biochemistry Laboratory, Faculty of Medicine, Moalem Street, Bushehr University of Medical Sciences.
City
Bushehr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research, Bushehr University of Medical Sciences
Full name of responsible person
Dr Ostovar
Street address
Research Department, Next to Salmon Farsi Hospital, Pardis Site, Bushehr Unibersity of Medical Sciences
City
Bushehr
Grant name
Grant code / Reference number
B-93-16-4
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research, Bushehr University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Ali Movahed
Position
Academic Member, PH.D
Other areas of specialty/work
Street address
Biochemistry Laboratory, Faculty of Medicine, Moalem Street, Bushehr University of Medical Sciences.
City
Bushehr
Postal code
751473537
Phone
+98 987712529198
Fax
+98 987712529198
Email
amovahed58@gmail.com ; amirali_19572yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Ali Movahed
Position
Academic Member, Ph. D
Other areas of specialty/work
Street address
Biochemistry Laboratory, Faculty of Medicine, Moalem Street, Bushehr University of Medical Sciences.
City
Bushehr
Postal code
751473537
Phone
+98 987712529198
Fax
+98 987712529198
Email
amovahed58@gmail.com ; amirali_1957@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Ali Movahed
Position
Academic Member, Ph.D
Other areas of specialty/work
Street address
Biochemistry Laboratory, Faculty of Medicine, Moalem Street, Bushehr University of Medical Sciences.
City
Bushehr
Postal code
751473537
Phone
+98 987712529198
Fax
+98 987712529198
Email
amovahed58@gmail.com ; amirali_1957@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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