None listed
Conditions
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.
Interventions
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.
Sponsors
CQUniversity Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Healthy volunteers
No
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
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
Outcome results
None listed