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Fruit and vegetable rich diets are associated with a reduced risk of cardiovascular disease (CVD). The protective effect may be ascribed to compounds contained within these foods, called flavonoids. Flavanols (epicatechin and procyanidins) are a particular group of flavonoids and are found mostly in apples, berry fruits, dark chocolate, tea and red wine. There is evidence to suggest that ingestion of flavanol rich foods and beverages beneficially alter 'markers' of CVD risk (e.g. blood pressure). The aim of this study is to determine the acute and chronic effects of apple derived flavanols on some risk markers for CVD.
This study is a single arm randomized, 4-phase crossover design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Epicatechin and procyanidin | Experimental | Low epicatechin and procyanidin doses |
|
| High Epicatechin and procyanidin | Experimental | High epicatechin and procyanidin doses |
|
| High Procyanidin | Experimental | High procyanidin only |
|
| Placebo | Placebo Comparator | No epicatechin and procyanidin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Epicatechin and procyanidin | Dietary Supplement | 70 mg epicatechin and 65 mg procyanidins once daily for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in systolic blood pressure from baseline | Baseline, 2 hours and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in plasma lipid profile from baseline | Baseline and 4 weeks | |
| Change in plasma endothelin-1 from baseline | Baseline and 4 weeks | |
| Changes in plasma nitric oxide metabolites from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Dr Kroon, PhD | Quadram Institute Bioscience | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Food Research | Norwich | Norfolk | NR4 7UA | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30475960 | Derived | 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. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C017674 | procyanidin |
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| High Epicatechin and procyanidin | Dietary Supplement | 140 mg epicatechin and 130 mg procyanidins once daily for 28 days |
|
| High procyanidin | Dietary Supplement | No epicatechin and 130 mg procyanidins once daily for 28 days |
|
| Placebo | Dietary Supplement | Placebo control once daily for 28 days |
|
| Baseline, 2 hours and 4 weeks |
| Changes in blood glucose from baseline | Baseline and 4 weeks |
| Changes in pulse wave velocity from baseline | Baseline, 2 hours and 4 weeks |