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Trial registered on ANZCTR


Registration number
ACTRN12616000465459
Ethics application status
Approved
Date submitted
2/04/2016
Date registered
8/04/2016
Date last updated
1/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of fruit extracts in reducing risk factors of heart disease in obese men
Scientific title
Efficacy of anthocyanins in improving haemostatic function under oxidative stress conditions in obese men
Secondary ID [1] 288911 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 298245 0
Thrombosis 298246 0
Condition category
Condition code
Diet and Nutrition 298388 298388 0 0
Obesity
Blood 298389 298389 0 0
Clotting disorders
Alternative and Complementary Medicine 298390 298390 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single Medox 80mg anthocyanin capsule contains: A purified extract from Bilberries and Black currants containing minimum 80 mg anthocyanincitrates; 110mg-170mg maltodextrin for stabilisation, Capsule - VCaps, HPMC, size 1, 7mmx20mm, 77 mg, neutral taste; Total weight of capsule: 390-410 mg. Dosage administered orally is: 320 mg/day (4 capsules - recommended dosage) for 28 days. Adherence to intervention will be measured by tablet return after 4 week supplementation. The wash out period is for two weeks before the start of supplementation with the next treatment (placebo) capsule for 28 days. The placebo capsule is a 265 mg maltodextrin capsule with a capsule weight of 80 mg: 345 mg total.The coloured maltodextrin consists of: Maltodextrin (87.5%), Wilton icing colour (red red 5%), Wilton icing colour (Royal blue 7.5%).
Participants will be required to perform an incremental exercise test on an electronically-braked cycle ergometer commenced with 3 min of unloaded cycling at a self-selected pedal cadence between 70 and 90 rpm. Thereafter, the power output will be increased by 15– 25 W·min-1, Participants will be instructed to maintain their preferred cadence for the duration of the test. The incremental exercise test will be terminated when participants were unable to consistently maintain a pedal cadence within 5 rpm of their preferred cadence despite strong verbal encouragement. This test will be performed only once at baseline during the first visit.
The exercise test will be performed at constant-load at an intensity equivalent to 70% of the incremental (VO2 max) exercise test for 60 minutes. This test will be performed on Day 1 (visit 2), Day 29 (visit 3), Day 43 (visit 4), and Day 72 (visit 5).
The incremental exercise test and standard exercise test will be supervised by an exercise physiologist.
Intervention code [1] 294373 0
Prevention
Intervention code [2] 294374 0
Treatment: Drugs
Intervention code [3] 294375 0
Treatment: Other
Comparator / control treatment
Placebo capsule. The placebo capsule is a 265 mg maltodextrin capsule with a capsule weight of 80 mg: 345 mg total.The coloured maltodextrin consists of: Maltodextrin (87.5%), Wilton icing colour (red red 5%), Wilton icing colour (Royal blue 7.5%). The capsule itself is made of cellulose.
Control group
Placebo

Outcomes
Primary outcome [1] 297865 0
Platelet Activation measurement (Flowcytometry-BD FACS Verse). Blood sample will be used in testing.
Timepoint [1] 297865 0
1. Sample collected at baseline pre and post exercise day 1 (before treatment)
2. Sample collected pre and post exercise on Day 29 after treatment 1
3. Sample collected at baseline pre and post exercise day 43 (before second treatment)
4. Sample collected pre and post exercise on Day 72 after treatment 2
Primary outcome [2] 297866 0
Whole blood platelet aggregation measurement using Chronolog platelet aggregometer
Timepoint [2] 297866 0
1. Sample collected at baseline pre and post exercise day 1 (before treatment)
2. Sample collected pre and post exercise on Day 29 after treatment 1
3. Sample collected at baseline pre and post exercise day 43 (before second treatment)
4. Sample collected pre and post exercise on Day 72 after treatment 2
Primary outcome [3] 297867 0
Oxidative stress biomarker 8-iso-PGF2alpha using Cayman Chemical ELISA assay kit. Blood sample (serum) will be used in testing.
Timepoint [3] 297867 0
1. Sample collected at baseline pre and post exercise day 1 (before treatment)
2. Sample collected pre and post exercise on Day 29 after treatment 1
3. Sample collected at baseline pre and post exercise day 43 (before second treatment)
4. Sample collected pre and post exercise on Day 72 after treatment 2
Secondary outcome [1] 322484 0
Food intake analysis using Xyris FoodWorks software. Food diaries completed by participants will be used in analysis.
Timepoint [1] 322484 0
After the end of the testing period i.e. on day 72 (One timepoint only)
Secondary outcome [2] 322485 0
Full Blood Count (AcT5 diff Beckman Coulter) (Primary outcome). Blood sample will be used in testing.
Timepoint [2] 322485 0
1. Sample collected at baseline pre and post exercise day 1 (before treatment)
2. Sample collected pre and post exercise on Day 29 after treatment 1
3. Sample collected at baseline pre and post exercise day 43 (before second treatment)
4. Sample collected pre and post exercise on Day 72 after treatment 2
Secondary outcome [3] 322486 0
Biochemical profile (Cobas Integra 400) (Primary outcome). Blood sample (Serum) will be used in testing
Timepoint [3] 322486 0
1. Sample collected at baseline pre and post exercise day 1 (before treatment)
2. Sample collected pre and post exercise on Day 29 after treatment 1
3. Sample collected at baseline pre and post exercise day 43 (before second treatment)
4. Sample collected pre and post exercise on Day 72 after treatment 2
Secondary outcome [4] 322523 0
Inflammatory marker C-reactive protein using COBAS Integra 400. Serum samples will be used in testing. This is a primary outcome
Timepoint [4] 322523 0
1. Sample collected at baseline pre and post exercise day 1 (before treatment)
2. Sample collected pre and post exercise on Day 29 after treatment 1
3. Sample collected at baseline pre and post exercise day 43 (before second treatment)
4. Sample collected pre and post exercise on Day 72 after treatment 2
Secondary outcome [5] 322525 0
Endothelial function test using Echo-Doppler. This is a primary outcome.
Timepoint [5] 322525 0
1. Sample collected at baseline pre and post exercise day 1 (before treatment)
2. Sample collected pre and post exercise on Day 29 after treatment 1
3. Sample collected at baseline pre and post exercise day 43 (before second treatment)
4. Sample collected pre and post exercise on Day 72 after treatment 2

Eligibility
Key inclusion criteria
1. BMI>30
2. Age 18-65
3. No current or prior CVD, coagulopathy, liver/kidney disease
4. Not currently on any anti-inflammatory, anti-coagulant, medication or energy/vitamin supplements
5. Full blood count within reference ranges
6. Non-smokers
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Excessive bleeding tendency, GI bleed or major surgery in last 6 wks
2. Liver Disease or coagulopathy
3. Anti-inflammatory, anti-platelet, anti-coagulation drugs
4. Participants on specific high antioxidant diet
5. Platelet count <100 & >450, Haematocrit<0.25

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)
Randomization will be performed by an individual independent to the trial using a computer software. Unique identifier codes will be allocated to the participants. These codes will be used on sample containers and other labelling procedures.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomization will be carried out using Microsoft Excel.
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
SPSS, GraphPad Prism - Two way repeated measures ANOVA with post-hoc tests.
A minimum sample size of 23 participants is required for 80% power to detect a 5% variation in the laboratory parameters measured, where a 3–5% standard deviation exists in the population, assuming an alpha error of 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/07/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
23
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 13006 0
4702 - Central Queensland

Funding & Sponsors
Funding source category [1] 293262 0
University
Name [1] 293262 0
CQUniversity Merit Grants
Country [1] 293262 0
Australia
Primary sponsor type
University
Name
CQUniversity Australia
Address
CQUniversity, Bruce Highway
North Rockhampton,
Queensland, Australia, 4702
Country
Australia
Secondary sponsor category [1] 292065 0
Commercial sector/Industry
Name [1] 292065 0
Biolink Group AS
Address [1] 292065 0
Hanaveien 4-6,
4327 Sandnes
Norway
Country [1] 292065 0
Norway

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294743 0
CQUniversity's Human Research Ethics Committee (EC00158)
Ethics committee address [1] 294743 0
Bruce Highway, North Rockhampton,
Queensland, Australia, 4702
Ethics committee country [1] 294743 0
Australia
Date submitted for ethics approval [1] 294743 0
17/03/2016
Approval date [1] 294743 0
13/04/2016
Ethics approval number [1] 294743 0
Approval number: H16/03-054

Summary
Brief summary
Aim: This study will investigate the potential of a natural dietary antioxidant extract capsule from blueberries and blackcurrants known as anthocyanin in improving haemostatic function and inflammation under oxidative stress conditions in obese men. It is hypothesized that by virtue of anthocyanin's antioxidant properties, it may help block pathways of blood clot formation, endothelial function and inflammation under conditions of oxidative stress in obese men.
Research design: Twenty-three healthy, sedentary, obese (BMI>30) male volunteers will be recruited for this randomised, double blind, placebo controlled crossover design, dietary intervention trial. Participation will involve 5 visits to the Haematology research laboratory. During visit 1, each participant will sign an informed consent and complete screening forms (physical activity, health history, and antioxidant questionnaires). After completion of these forms a member of the research team will determine the height, weight, waist to hip ratio, body fat (using a 3 site skin fold assessment technique) and blood pressure of each participant using standard procedures. Participants will then be asked to complete an incremental exercise test on a cycle ergometer using standard procedures. During the incremental exercise test expired gas will be collected by a metabolic cart (ParvoMedics) using standard procedures. During visit 2, a 25 mL baseline blood sample will be collected from the participant's arm vein using standard venepuncture procedures by a trained phlebotomist, followed by body mass, resting heart rate, resting energy expenditure and blood pressure measurements. A constant load exercise test will then be performed at moderate intensity (70% of aerobic capacity) for 60 min. Each test will be preceded by 3 min of unloaded cycling and with an active cool down for 6 min. Another blood sample (25 mL) will be collected using standard procedures after the exercise test. A non-invasive echo-Doppler to assess the flow mediated dilation of the brachial artery will be performed to assess endothelial function before and after the exercise test. The participant will then consume either 320 mg/day of anthocyanin capsules or placebo capsules for 28 days. After 4 weeks of capsule supplementation, i.e. on the 29th day (visit 3), two blood samples will be collected before and after an exercise test (similar to visit 2). After a 2 week wash out period with no supplement intake, a supplementation cross-over will be performed, and exercise intervention and sample collection procedures repeated on day 43 and day 72.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64890 0
Dr Abishek Santhakumar
Address 64890 0
School of Medical and Applied Sciences,
CQUniversity, Bruce Highway
North Rockhampton, Queensland, Australia, 4702.
Country 64890 0
Australia
Phone 64890 0
+61749309626
Fax 64890 0
Email 64890 0
a.santhakumar@cqu.edu.au
Contact person for public queries
Name 64891 0
Abishek Santhakumar
Address 64891 0
School of Medical and Applied Sciences
CQUniversity, Bruce Highway
North Rockhampton, Queensland, Australia, 4702
Country 64891 0
Australia
Phone 64891 0
+61749309626
Fax 64891 0
Email 64891 0
a.santhakumar@cqu.edu.au
Contact person for scientific queries
Name 64892 0
Abishek Santhakumar
Address 64892 0
School of Medical and Applied Sciences
CQUniversity, Bruce Highway
North Rockhampton, Queensland, Australia, 4702
Country 64892 0
Australia
Phone 64892 0
+61749309626
Fax 64892 0
Email 64892 0
a.santhakumar@cqu.edu.au

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.

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