None listed
Conditions
Brief summary
This project aims to determine if a major flavonoid component found in apple skin can improve blood vessel function and blood pressure in human volunteers. The apple variety Cripps Pink, marketed as ‘Pink Lady’ is particularly rich in the flavonoid quercetin. Our previous short term studies with pure quercetin and apples show improved blood vessel function. We now wish to determine if long term consumption (4 weeks) of apples will improve vessel function and lower blood pressure and try to understand the biochemical mechanism of this beneficial effect.
Interventions
Acute component of study: 1 whole apple (medium size) + 1 apple skin blended with 1/2 cup water.
Measurements will be taken before (baseline) and 2 hours after ingestion of the treatment.
Long-term component of study: 1 whole apple (medium size) + 1 apple skin blended with 1/2 cup water twice a day for 4 weeks.
Volunteers will be asked to only use 'Pink Lady' apples.
Volunteers will be asked to fill in a diary and we will also be measuring urinary metabolites to monitor adherence to the inte
Acute component of study: 1 whole apple (medium size) + 1 apple skin blended with 1/2 cup water. Measurements will be taken before (baseline) and 2 hours after ingestion of the treatment. Long-term component of study: 1 whole apple (medium size) + 1 apple skin blended with 1/2 cup water twice a day for 4 weeks. Volunteers will be asked to only use 'Pink Lady' apples. Volunteers will be asked to fill in a diary and we will also be measuring urinary metabolites to monitor adherence to the intervention. Measurements will be taken on day 1 (baseline) and day 28. The washout period will be two weeks prior to commencing the study and for two weeks inbetween treatment periods. During these times and throughout the study we will ask volunteers to reduce their flavonoid intake: - Limit tea to 1 or less cups per day - Limit coffee to 2 or less cups per day - Limit dark chocolate - Limit red wine - Reduced onion intake - Do not eat any other apples - Avoid eating large quantities of curly kale, leeks, broccoli, capers and blueberries.
Sponsors
The University of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
We are looking for volunteers with one or more of the following: - Slightly elevated blood pressure (120 < systolic BP < 160) - High blood sugar (5.6 < glucose < 6.5) - High cholesterol (5 < total cholesterol < 8) - Central obesity (men > 94cm; women > 80cm) It is critical to the study that participants are not currently taking any blood pressure or cholesterol lowering medication.
Exclusion criteria
- Current or recent (12 months) smoking - Body mass index less than 18 or greater than 40 kg/m2 - History of cardiovascular or peripheral vascular disease - A systolic blood pressure less than 100 or greater than 160 mmHg. - A diastolic blood pressure less than 50 or greater than 100 mmHg - Diagnosed diabetes, and non-diabetic individuals with fasting plasma glucose concentrations greater than 6.5 mmol/L - A psychiatric illness - Other major illnesses such as cancer - Current or recent (within previous 6 months) significant weight loss or gain ( greater than 6% of body weight) or actively trying to lose weight - Alcohol intake greater than 210g per week for women and greater than 280 g per week for men - Women who are lactating, pregnant or wishing to become pregnant during the study
Outcome results
None listed