ANZCTR - Registration

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity

Thrombosis

Condition category

Condition code

Diet and Nutrition

Obesity

Blood

Clotting disorders

Alternative and Complementary Medicine

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]

Prevention

Intervention code [2]

Treatment: Drugs

Intervention code [3]

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]

Platelet Activation measurement (Flowcytometry-BD FACS Verse). Blood sample will be used in testing.

Timepoint [1]

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]

Whole blood platelet aggregation measurement using Chronolog platelet aggregometer

Timepoint [2]

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]

Oxidative stress biomarker 8-iso-PGF2alpha using Cayman Chemical ELISA assay kit. Blood sample (serum) will be used in testing.

Timepoint [3]

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]

Food intake analysis using Xyris FoodWorks software. Food diaries completed by participants will be used in analysis.

Timepoint [1]

After the end of the testing period i.e. on day 72 (One timepoint only)

Secondary outcome [2]

Full Blood Count (AcT5 diff Beckman Coulter) (Primary outcome). Blood sample will be used in testing.

Timepoint [2]

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]

Biochemical profile (Cobas Integra 400) (Primary outcome). Blood sample (Serum) will be used in testing

Timepoint [3]

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]

Inflammatory marker C-reactive protein using COBAS Integra 400. Serum samples will be used in testing. This is a primary outcome

Timepoint [4]

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]

Endothelial function test using Echo-Doppler. This is a primary outcome.

Timepoint [5]

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

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]

4702 - Central Queensland

Funding & Sponsors

Funding source category [1]

University

Name [1]

CQUniversity Merit Grants

Country [1]

Australia

Primary sponsor type

University

Name

CQUniversity Australia

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Biolink Group AS

Country [1]

Norway

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

CQUniversity's Human Research Ethics Committee (EC00158)

Ethics committee address [1]

Bruce Highway, North Rockhampton,
Queensland, Australia, 4702

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/03/2016

Approval date [1]

13/04/2016

Ethics approval number [1]

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

Public notes

Contacts

Principal investigator

Name

Dr Abishek Santhakumar

Address

School of Medical and Applied Sciences,
CQUniversity, Bruce Highway
North Rockhampton, Queensland, Australia, 4702.

Country

Australia

Phone

+61749309626

Email

a.santhakumar@cqu.edu.au

Contact person for public queries

Name

Abishek Santhakumar

Address

School of Medical and Applied Sciences
CQUniversity, Bruce Highway
North Rockhampton, Queensland, Australia, 4702

Country

Australia

Phone

+61749309626

Email

a.santhakumar@cqu.edu.au

Contact person for scientific queries

Name

Abishek Santhakumar

Address

School of Medical and Applied Sciences
CQUniversity, Bruce Highway
North Rockhampton, Queensland, Australia, 4702

Country

Australia

Phone

+61749309626

Email

a.santhakumar@cqu.edu.au

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