The Effects of Apple Derived Flavanols on Cardiovascular Disease Risk (FLAVASCULAR Study)
NCT ID: NCT02013856
Last Updated: 2016-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2014-07-31
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Low Epicatechin and procyanidin
Low epicatechin and procyanidin doses
Low Epicatechin and procyanidin
70 mg epicatechin and 65 mg procyanidins once daily for 28 days
High Epicatechin and procyanidin
High epicatechin and procyanidin doses
High Epicatechin and procyanidin
140 mg epicatechin and 130 mg procyanidins once daily for 28 days
High Procyanidin
High procyanidin only
High procyanidin
No epicatechin and 130 mg procyanidins once daily for 28 days
Placebo
No epicatechin and procyanidin
Placebo
Placebo control once daily for 28 days
Interventions
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Low Epicatechin and procyanidin
70 mg epicatechin and 65 mg procyanidins once daily for 28 days
High Epicatechin and procyanidin
140 mg epicatechin and 130 mg procyanidins once daily for 28 days
High procyanidin
No epicatechin and 130 mg procyanidins once daily for 28 days
Placebo
Placebo control once daily for 28 days
Eligibility Criteria
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Inclusion Criteria
* Systolic blood pressure 130 - 159 mmHg
Exclusion Criteria
* Kidney or liver disease/problems
* Diabetes
* Asthmatics (unless no medication taken for 1 year - occasional use will be assessed on an individual basis)
* Prescribed anti-hypertensive medication
* HRT (unless the participant has used the therapy for ≥ 6 months)
* Lipid lowering therapies e.g. statins
* Other medications that may affect any of the study outcome measures e.g. vasodilators (this will be assessed on a case by case basis)
* Current smoker (or stopped for less than 3 months)
* Throat surgery or neck injury
* Allergy to apples
* Consumption of fish oil supplements unless willing to discontinue them up for 4 weeks preceding the start of the study and for the duration of the study. (All other supplements will be assessed on a case by case basis)
* Gastro-intestinal diseases (excluding hiatus hernia unless symptomatic or study intervention/procedure is contra-indicated).
* 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 ml.
* 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 (mmHg)) during the course of the trial.
50 Years
ALL
Yes
Sponsors
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Quadram Institute Bioscience
OTHER
Responsible Party
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Principal Investigators
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Paul Dr Kroon, PhD
Role: PRINCIPAL_INVESTIGATOR
Quadram Institute Bioscience
Locations
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Institute of Food Research
Norwich, Norfolk, United Kingdom
Countries
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References
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Hollands WJ, Tapp H, Defernez M, Perez Moral N, Winterbone MS, Philo M, Lucey AJ, Kiely ME, Kroon PA. Lack of acute or chronic effects of epicatechin-rich and procyanidin-rich apple extracts on blood pressure and cardiometabolic biomarkers in adults with moderately elevated blood pressure: a randomized, placebo-controlled crossover trial. Am J Clin Nutr. 2018 Nov 1;108(5):1006-1014. doi: 10.1093/ajcn/nqy139.
Other Identifiers
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IFR05/2013
Identifier Type: -
Identifier Source: org_study_id
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