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Trial registered on ANZCTR
Registration number
ACTRN12609000023257
Ethics application status
Approved
Date submitted
28/11/2008
Date registered
12/01/2009
Date last updated
12/11/2013
Type of registration
Prospectively registered
Titles & IDs
Public title
Acute effects of resveratrol on circulatory function in obese people with elevated blood pressure.
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Scientific title
Resveratrol supplementation for improving endothelium dependent vasodilator function and attenuating pressor responses to exercise in obese people with elevated blood pressure.
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Secondary ID [1]
283576
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Nil
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Universal Trial Number (UTN)
N/A
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Endothelial vasodilator function
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Blood pressure response to exercise
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Condition category
Condition code
Cardiovascular
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Cardiovascular
4205
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0
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Volunteers will be required to consume three doses of resveratrol (30, 90 or 270mg on one occasion per dose).
There will be four separate visits (of one hour duration each) to the research centre which will occur with a one week washout between visits. At each visit the participant will consume one dose of resveratrol (or placebo) per visit.
Measurements of endothelial vasodilator function and blood pressure responses to exercise will begin one hour after consumption of each single dose of resveratrol. These measures will be repeated at each visit.
Resveratrol will be administered orally in capsules. Each of the three doses of resveratrol consists of multiple capsules; all capsules that make up a single dose will be consumed at once.
Doses will be made up of combinations of 15 and 75 mg resveratrol capsules as follows:
1) 30 mg: 2 capsules of 15 mg + 4 placebo capsules
2) 90 mg: 1 capsule of 75 mg + 1 capsule of 15 mg + 4 placebo
3) 270 mg: 3 capsules of 75 mg + 3 of 15 mg
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Intervention code [1]
3730
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Lifestyle
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Comparator / control treatment
Placebo capsules are identical in appearance to the active capsules but contain an inert filler consisting of Calcium Hydrogen Phosphate, microcrystalline cellulose (MCC) of various particle sizes including Prosolv 50 and talcum powder (hydrated magnesium silicate).
There are a total of four testing visits for this trial. Three will include the consumption of a single dose of resveratrol and one will be the placebo and each visit will be one week apart.
Volunteers will take an oral dose of six placebo capsules all at once on a single occasion.
Measurements of endothelial vasodilator function and blood pressure responses to exercise will begin one hour after consumption of the placebo.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Degree of change in vasodilator function assessed by flow mediated dilatation in the brachial artery.
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Assessment method [1]
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Timepoint [1]
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There will be four time points which will occur one week apart. At each visit testing will commence one hour after consumption of each dose of resveratrol or placebo.
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Secondary outcome [1]
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Blood pressure responses to exercise will be assessed continuously using a Finapres blood pressure monitor, which measures blood pressure non-invasively through the finger.
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Assessment method [1]
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Timepoint [1]
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There will be four time points which will occur one week apart. At each visit testing will commence one hour after consumption of each dose of resveratrol or placebo.
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Secondary outcome [2]
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A small blood sample will be taken one hour after the consumption of each dose of resveratrol or placebo to assess plasma levels of resveratrol.
Blood samples will be sent to DSM in Switzerland for analysis.
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Assessment method [2]
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Timepoint [2]
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There will be four time points which will occur one week apart. At each visit testing will commence one hour after consumption of each dose of resveratrol or placebo.
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Eligibility
Key inclusion criteria
Men or post-menopausal women (self reported cessation of menses for at least 12 months) aged 30 - 70 years.
b) Volunteers will be overweight or obese (Body mass index (BMI) ranging from 25kg/m2 to 35kg/m2), and
c) have high-normal BP or untreated mild primary hypertension (systolic BP 130-160 mmHg or Diastolic BP 85-100 mmHg)
d) but are otherwise healthy.
Volunteers will provide a blood sample on the first day of testing to assess blood chemistry, coagulation and hematology outcomes to ensure there are no underlying medical conditions that would influence the study outcomes.
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Minimum age
30
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
a) have cardiovascular disease, renal disease or diabetes
b) take BP lowering medication
c) have any other medical condition or treatments (including supplements) which, in the opinion of the investigators, may influence the outcome of the study
d) smoke or use nicotine replacement therapy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Volunteers will be recruited via letter from database of previous participants in trial at the Nutritional Physiology Research Centre who have been identified as meeting the inclusion criteria. Volunteers will be requested to attend the research centre for a screening to assess their eligibility for the trial and enrolled based on body mass index and blood pressure values obtained at that visit.
Eligibility will be determined by the study coordinator. Volunteers will be required to consume each dose once, the order of which will be determined by a random number generator. Doses will be allocated a letter A-D for identification. The identity of the supplement will be held by an individual separate to the study which will not be decoded until all data has been analysed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/12/2008
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Actual
31/01/2009
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Date of last participant enrolment
Anticipated
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Actual
30/03/2009
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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DSM Nutritional Products
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Address [1]
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PO Box 2676
CH-4002 Basel
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Country [1]
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Switzerland
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Primary sponsor type
Individual
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Name
Professor Peter Howe
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Address
Nutritional Physiology Research Centre
University of South Australia, PO Box 2471
Adelaide, South Australia, 5001
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Dr Narelle Berry
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Address [1]
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Nutritional Physiology Research Centre
University of South Australia, PO Box 2471
Adelaide, South Australia, 5001
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of South Australia Human Research Ethics Committee
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Ethics committee address [1]
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General Purpose Building, Mawson Lakes Campus,
Mawson Lakes Boulevard, Mawson Lakes,
South Australia, 5095
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
6251
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Approval date [1]
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27/11/2008
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Ethics approval number [1]
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P237/08
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Summary
Brief summary
It is well established that obesity and elevated blood pressure can lead to impaired vascular function. However, it is less clear how impaired blood vessel function affects cardiovascular and, consequently, blood pressure responses during exercise. Exaggerated blood pressure responses to exercise can be an early risk factor for the development of future hypertension.
The aim of this study is to establish a dose/response relationship for the effect of resveratrol on endothelial vasodilator function as measured by flow mediated dilation (FMD) and blood pressure (BP), both at rest and during exercise, in volunteers who are overweight/obese with elevated BP.
The results of this study will inform the design of future trials which will explore the effect of combinations of resveratrol and other vasoactive nutrients on cardiovascular and mental health.
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Trial website
N/A
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Trial related presentations / publications
Wong, R H X; Howe, P R C; Buckley, J D; Coates, A M; Kunz, I; Berry, N M, Acute resveratrol supplementation improves flow-mediated dilatation in overweight/obese individuals with mildly elevated blood pressure, Nutrition, metabolism, and cardiovascular diseases, 2011, 21(11), 851 – 856.
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Public notes
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Contacts
Principal investigator
Name
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Prof Peter Howe
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Address
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University of Newcastle
School of Biomedical Sciences & Pharmacy
University Drive
Callaghan
NSW 2308
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Country
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Australia
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Phone
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+61 2 49217309
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Dr Narelle Berry
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Address
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Nutritional Physiology Research Centre
University of South Australia, PO Box 2471
Adelaide, South Australia, 5001
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Country
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Australia
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Phone
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+61 8 83021817
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Fax
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+61 8 83022178
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Professor Peter Howe
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Address
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Nutritional Physiology Research Centre
University of South Australia, PO Box 2471
Adelaide, South Australia, 5001
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Country
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Australia
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Phone
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+61 8 83021200
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Fax
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+61 8 83022178
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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