Bioavailability and Vascular Effects of Apple Polyphenols
- Conditions
- Healthy
- Interventions
- Other: Apple extract delivering 70 mg epicatechinOther: Apple extract delivering 140 mg epicatechinOther: Apple granules delivering 70 mg epicatechinOther: Water delivering no epicatechin
- Registration Number
- NCT01097226
- Lead Sponsor
- Quadram Institute Bioscience
- Brief Summary
The main purpose of this study is to determine the oral bioavailability of flavanols (polyphenolic compounds) from apple granules and an apple extract delivered in a water based beverage at two different doses. We will also investigate the effects of apple flavanols on nitric oxide production.
- Detailed Description
This study is a randomized four phase crossover trial investigating the bioavailability of apple flavanols and the effects on nitric oxide products, a surrogate marker for changes in endothelial function. Each test phase will comprise a 3 day period of intervention which will be identical in nature (except for the test product consumed) and separated by a minimum of 1 week. On days 1-3 of each test phase volunteers will consume a low flavanol diet. After consumption of the test product on the morning of day 2, blood and urine samples will be collected at regular intervals for the next 24h.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- Men and women aged 45-70 years
- Smokers (or have quit smoking less than 1 year ago)
- Regular prescribed medication (excluding some eye and skin medication that is judged not to affect study outcome)
- Non-prescribed medication that may affect the study data, e.g. aspirin. The use of non prescribed medications will be assessed on an individual basis.
- Dietary supplements or herbal remedies which may affect the study data unless the volunteer is willing to discontinue them for 1 month prior to starting study. (Please note that some supplements may not affect the study and this will be assessed on an individual basis).
- Gastro-intestinal diseases (excluding hiatus hernia unless symptomatic or study intervention/procedure is contra-indicated).
- Diabetics
- Known cardiovascular disease
- Asthmatics (unless no medication taken for 1 year)
- Lactose Intolerance
- Pregnancy or have been pregnant within the last 12 months
- Parallel participation in another research project which involves dietary intervention
- Participation in another research project which has involved blood sampling within the last four months unless the total amount of combined blood from both studies does not exceed 470 mls.
- Has donated or intends to donate blood within 16 weeks prior to or during the study period.
- Depressed or elevated blood pressure measurements (<90/50 or 95/55 if symptomatic or >160/100)
- Any person related to or living with any member of the study team
- Results of the clinical screening which indicate or are judged by the HNU Medical Advisor to be indicative of a health problem which could compromise the well-being of the volunteer if they participated or which could affect the study data.
- Alcohol consumption > approximately 20 g alcohol/day (2.5 units/day)
- BMI <19.5 or > 35
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Apple flavanols Apple extract delivering 140 mg epicatechin - Apple flavanols Apple granules delivering 70 mg epicatechin - Apple flavanols Water delivering no epicatechin - Apple flavanols Apple extract delivering 70 mg epicatechin -
- Primary Outcome Measures
Name Time Method Area under the plasma pharmacokinetic curve for total epicatechin 24 hours
- Secondary Outcome Measures
Name Time Method Additional measures of bioavailability: Plasma Cmax, Tmax, half life and urinary excretion 24 hours Changes in levels of nitric Oxide metabolites as a surrogate measure of endothelial function after consumption of apple flavanols 24 hours
Trial Locations
- Locations (1)
Institute of Food Research
🇬🇧Norwich, Norfolk, United Kingdom