None listed
Conditions
Brief summary
Polyphenols are bioactive compounds found in plants. These compounds have been found to have beneficial effects on vascular function. Arguably the most well-established vascular benefits are attributed to flavanols from cacao beans. Berry fruits are another rich source of polyphenols that have vasoactive properties, and there is a growing body of research exploring these effects in various berries (blueberries, cranberries, strawberries) and other fruit products with similar polyphenol composition. A key polyphenol in berries and other fruits believed to provide much of the benefit is anthocyanin. When given as an isolated extract 320mg anthocyanin has been found to improve blood vessel function both acutely and in response to chronic consumption over 12 weeks. Thus the primary focus of this project is to evaluate the effects of berry extracts of differing polyphenol dose on vascular endothelial function.
Interventions
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 commen
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.
Sponsors
Dr Kade Davison
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to 70 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed