Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000060943
Ethics application status
Approved
Date submitted
13/01/2011
Date registered
17/01/2011
Date last updated
10/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Sustained effects of resveratrol on circulatory function in obese adults
Scientific title
A 12-week, randomised, double-blind, placebo controlled study of the sustained effects of ResvidaTM on circulatory function and cognition in obese adults
Secondary ID [1] 253375 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endothelial vasodilator function 260923 0
Cognitive function 260924 0
Condition category
Condition code
Cardiovascular 259055 259055 0 0
Diseases of the vasculature and circulation including the lymphatic system
Mental Health 259056 259056 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Volunteers will consume a 75 mg dose of resveratrol (resVida 'Trademark (TM)', DSM Nutritional Products, Switzerland) daily for 6 weeks. This supplement will be delivered orally in capsule form.
There will be three separate visits to the Nutritional Physiology Research Centre (of 2 hours duration each), baseline, week 6 then crossed over to alternate dose (active or placebo), then assessments at week 12. There is no washout between the active and placebo arm.
Intervention code [1] 257821 0
Lifestyle
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). This supplement will be delivered orally in capsule form.
There will be three separate visits to the Nutritional Physiology Research Centre (of 2 hours duration each), baseline, week 6 then crossed over to alternate dose (active or placebo), then assessments at week 12.
Control group
Placebo

Outcomes
Primary outcome [1] 259911 0
Degree of change in vasodilator function assessed by flow mediated dilatation in the brachial artery.
Timepoint [1] 259911 0
There will be 5 assessments at three time points. Baseline, week 6, then crossover to alternate dose (active or placebo), then assessment at week 12, plus an acute supplementation assessment at week 6 and 12. The acute assessments will be performed after the chronic assessments have been made on a given visit. The purpose of these measures is to determine an acute effect may be potentiated by the chronic exposure
Secondary outcome [1] 268805 0
The Stroop test. This test requires participants to read the names of colours and then name the colours in which incongruent colour names are printed. The ratio between time taken to name colours compared with reading colour names reflects the degree of interference afforded by suppressing the habit of reading words in order to name colours. Uncorrected errors during the colour naming trial reflect failures of inhibition.
Timepoint [1] 268805 0
There will be 3 assessments at baseline, week 6, then crossover to alternate dose (active or placebo), then an assessment at week 12
Secondary outcome [2] 268811 0
Supine blood pressure, heart rate and arterial compliance will be recorded with the Hypertension Diagnostics Cardiovascular Profiling Iinstrument (CR2000), after lying quietly for at least 10 min. Four consecutive readings will be taken at 1 min intervals by a single observer. The first reading will be discarded and an average of the remaining measurements will be taken
Timepoint [2] 268811 0
There will be 3 assessments at baseline, week 6, then crossover to alternate dose (active or placebo), then an assessment at week 12

Eligibility
Key inclusion criteria
Men or post-menopausal women (self reported cessation of menses for at least 12 months)
Age: 40-70 years.
Obese (BMI 30-45 kg/m2) but otherwise healthy
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Supine BP above SBP 160 mmHg or DBP 100 mmHg
- Having cardiovascular disease, renal disease or diabetes
- Taking BP lowering medication
- Having any other medical condition or treatments (including supplements) which, in the opinion of the investigators, may influence the outcome of the study
- Smokers or those using nicotine replacement therapy
- Those unwilling to restrict food items containing high amounts of polyphenols (grape, grape juice, wine, peanuts, peanut butter, mulberries, green tea, soy and soy products)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited from the general population by newspaper advertisements, flyers, electronic mail advertisements and radio/television announcements. Volunteers will be screened via questionnaire to assess their eligibility for the trial. Eligibility will be determined by the study coordinator. Volunteers will be required to consume each supplement (active or placebo) daily for 6 weeks, then crossed over to alternate dose, the order will be determined by a random number generator. Doses will be allocated a letter A or B for identification. The identity of the supplement will be held by an individual separate to the study and will not be decoded until all the data has been analysed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/02/2011
Actual
7/03/2011
Date of last participant enrolment
Anticipated
Actual
15/06/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 3534 0
5000-5999

Funding & Sponsors
Funding source category [1] 258316 0
University
Name [1] 258316 0
University of South Australia
Country [1] 258316 0
Australia
Funding source category [2] 258317 0
Commercial sector/Industry
Name [2] 258317 0
DSM Nutritional Products
Country [2] 258317 0
Switzerland
Primary sponsor type
Individual
Name
Professor Peter Howe
Address
Nutritional Physiology Research Centre,
University of South Australia
PO Box 2471
Adelaide, 5001
Country
Australia
Secondary sponsor category [1] 257456 0
Individual
Name [1] 257456 0
Dr Narelle Berry
Address [1] 257456 0
University of South Australia
PO Box 2471
Adelaide, 5001
Country [1] 257456 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260278 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 260278 0
Ethics committee country [1] 260278 0
Australia
Date submitted for ethics approval [1] 260278 0
Approval date [1] 260278 0
11/01/2011
Ethics approval number [1] 260278 0
0000022433

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32070 0
Prof Peter Howe
Address 32070 0
Clinical Nutrition Research Centre
University of Newcastle
School of Biomedical Sciences & Pharmacy
Callaghan NSW 2308
Country 32070 0
Australia
Phone 32070 0
+61 02 4921 7309
Fax 32070 0
Email 32070 0
[email protected]
Contact person for public queries
Name 15317 0
Dr Narelle Berry
Address 15317 0
Nutritional Physiology Research Centre
University of South Australia, PO Box 2471
Adelaide, 5001
Country 15317 0
Australia
Phone 15317 0
+61 8 83021817
Fax 15317 0
+61 8 83022178
Email 15317 0
[email protected]
Contact person for scientific queries
Name 6245 0
Prof Peter Howe
Address 6245 0
Nutritional Physiology Research Centre
University of South Australia, PO Box 2471
Adelaide, 5001
Country 6245 0
Australia
Phone 6245 0
+61 8 83021200
Fax 6245 0
+61 8 83022178
Email 6245 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseThe pleiotropic neuroprotective effects of resveratrol in cognitive decline and Alzheimer's disease pathology: From antioxidant to epigenetic therapy.2021https://dx.doi.org/10.1016/j.arr.2021.101271
N.B. These documents automatically identified may not have been verified by the study sponsor.