Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000270415
Ethics application status
Approved
Date submitted
20/01/2016
Date registered
1/03/2016
Date last updated
3/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of a Berry Extract on Vascular Function
Scientific title
A randomized, double blind, placebo controlled, crossover study to evaluate the effect of two doses of berry extract on vascular function in overweight adults
Secondary ID [1] 288125 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 297003 0
Condition category
Condition code
Diet and Nutrition 297255 297255 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomized three-­way cross­over design will be used to evaluate the acute and short term chronic effects of supplementation with two doses of a berry extract (250mg and 500mg powdered extract) versus a placebo. The berry extract is a concentrated and dried powder from a North American native berry with a final composition of polyphenols, chlorogenic acids, and fibre (cellulose, pectins, lignins, tannins). Thirty overweight adults will be recruited by public advertisements. Prior to the commencement of the study volunteers will complete a questionnaire designed to assess general health and eligibility, and will have their height and weight measured. They will consume each of the supplements (a single capsule each day) for 14 days with a minimum of one week ­long wash out period between each supplement period. Participants will complete a series of tests at the beginning and end of each 14­-day supplementation period (6 visits in total for the intervention). At each visit, participants will present to the clinic in the fasted state (10 to ­12 hr without food or drink other than water), and will complete a series of anthropometric (e.g. height, weight, waist circumference) and vascular health assessments (e.g. flow-­mediated dilatation (FMD), blood pressure and arterial stiffness), Participants will then consume a single supplement dose before undergoing a second FMD test at 1 hour post consumption (expected peak FMD change). This will determine the acute effects of berry supplementation on vascular health for each of the two doses as well as the chronic effect of 14 days supplementation at each dose compared to placebo. Each testing session is expected to take approximately 120 minutes. Compliance with the supplementation program will be monitored by participants completing a supplement consumption diary and returning their capsule container with any remaining capsules. Any remaining capsules will be counted to determine the number taken.
Intervention code [1] 293435 0
Treatment: Other
Comparator / control treatment
Coloured maltodextrin (1 capsule per day)
Control group
Placebo

Outcomes
Primary outcome [1] 296838 0
Flow­-mediated dilation, measured using a two dimensional B-mode ultrasound
Timepoint [1] 296838 0
The beginning and end of each 14­ day supplementation period (both fasted and 1hr following consumption of supplement).
Secondary outcome [1] 319493 0
Blood pressure, measured using an oscillometric device
Timepoint [1] 319493 0
The beginning and end of each 14­ day supplementation period
Secondary outcome [2] 319494 0
Arterial stiffness, measured using a Sphygmocor device
Timepoint [2] 319494 0
The beginning and end of each 14­ day supplementation period
Secondary outcome [3] 319495 0
Cerebrovascular reactivity measured using transcranial doppler ultrasonography
Timepoint [3] 319495 0
The beginning and end of each 14­ day supplementation period

Eligibility
Key inclusion criteria
1. Men aged over 45 years of age and post­menopausal women.
2. BMI between 26.9 and 29.99
3. Blood pressure less than 140/90 mmHg
4. Able and willing to give informed consent and comply with all study protocol procedures.
Minimum age
45 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. More than 150 min/week of moderate activity or more than 75 min/week of intense activity
2. Taking vasoactive medications (e.g. statins, aspirin, blood pressure lowering drugs) or food supplements (e.g. fish oil)
3. Smoking
4. Weight loss of more than 10% body weight in the previous 6 months
5. Currently treated with a diet for weight loss
6. Reported participation in another study within 1 month before the study start
7. Chronic­-acute disease, including any kind of metabolic abnormality or major cardiovascular risk factor or both.

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)
Double-­blind randomisation. Supplement containers will be coded and labelled by a third­party and capsules are identical to ensure that all researchers and participants are blinded to active and control treatments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Via random number generator - third party
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixed models procedure to determine the effects of treatment and order on outcome variables

The primary outcome measure for this trial is flow-mediated dilatation. Due to the novelty of this particular investigation there is no direct evidence on which to determine the sample size required for sufficient statistical power to detect an effect. As such we have based our calculation on a recent study investigating the effects of red orange consumption on endothelial function due to similar total polyphenol and anthocyanin dosing to that proposed here (Buscemi et al 2012).

A total of 26 participants will be required for this three-way crossover study. The probability is 80 percent that the study will detect a treatment difference at a two-sided 0.05 significance level, if the true difference between treatments is 2.200 units. This is based on the assumption that the within-patient standard deviation of the response variable is 2.7. The proposed figure of 30 participants is to allow for possible participant attrition across the intervention.

Reference
Buscemi, S.; Rosafio, G.; Arcoleo, G.; Mattina, A.; Canino, B.; Montana, M.; Verga, S.; Rini, G., Effects of red orange juice intake on endothelial function and inflammatory markers in adult subjects with increased cardiovascular risk. The American journal of clinical nutrition 2012, 95, 1089-95.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
22/02/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 292537 0
Commercial sector/Industry
Name [1] 292537 0
Naturex DBS LLC
Country [1] 292537 0
United States of America
Primary sponsor type
Individual
Name
Dr Kade Davison
Address
Alliance for Research in Exercise, Nutrition and Activity
School of Health Sciences
University of South Australia
PO Box 2471 Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 291253 0
Individual
Name [1] 291253 0
Dr Alison Hill
Address [1] 291253 0
Alliance for Research in Exercise, Nutrition and Activity
School of Pharmacy & Medical Sciences
University of South Australia
PO Box 2471 Adelaide SA 5001
Country [1] 291253 0
Australia
Secondary sponsor category [2] 291254 0
Individual
Name [2] 291254 0
Lucy Fairlie-Jones
Address [2] 291254 0
Alliance for Research in Exercise, Nutrition and Activity
School of Health Sciences
University of South Australia
PO Box 2471 Adelaide SA 5001
Country [2] 291254 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294011 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 294011 0
Ethics committee country [1] 294011 0
Australia
Date submitted for ethics approval [1] 294011 0
31/08/2015
Approval date [1] 294011 0
28/10/2015
Ethics approval number [1] 294011 0
0000034662

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

Contacts
Principal investigator
Name 62138 0
Dr Kade Davison
Address 62138 0
Alliance for Research in Exercise, Nutrition and Activity
School of Health Sciences
University of South Australia
PO Box 2471 Adelaide SA 5001
Country 62138 0
Australia
Phone 62138 0
+61 8 8302 1152
Fax 62138 0
Email 62138 0
[email protected]
Contact person for public queries
Name 62139 0
Kade Davison
Address 62139 0
Alliance for Research in Exercise, Nutrition and Activity
School of Health Sciences
University of South Australia
PO Box 2471 Adelaide SA 5001
Country 62139 0
Australia
Phone 62139 0
+61 8 8302 1152
Fax 62139 0
Email 62139 0
[email protected]
Contact person for scientific queries
Name 62140 0
Kade Davison
Address 62140 0
Alliance for Research in Exercise, Nutrition and Activity
School of Health Sciences
University of South Australia
PO Box 2471 Adelaide SA 5001
Country 62140 0
Australia
Phone 62140 0
+61 8 8302 1152
Fax 62140 0
Email 62140 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

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