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| Name | Class |
|---|---|
| University of Turku | OTHER |
| 4Pharma Ltd. | INDUSTRY |
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Effect of apple polyphenols on FMD.
The aim of this single centre, repeated-dose, double-blind, placebo-controlled, crossover study is to test the hypothesis that an orally ingested apple polyphenol extract rich in epicatechin and flavan-3-ol oligomers improves brachial artery endothelium-dependent vasodilation function (FMD) in volunteer subjects with borderline hypertension. FMD and endothelium-independent nitrate-mediated vasodilatation (NMD) of the left brachial artery will be investigated with ultrasonography at the start and end of both treatment periods. Biomarkers of vascular function and epicatechin (and metabolite) concentrations will be determined from blood samples taken at the start and end of both treatment periods. Diet diary data will be collected for the evaluation of the possible effects of diet on the study results. Adverse events data will be collected throughout the study. Safety laboratory determinations will be performed at the last visit of both treatment periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epicatechin | Active Comparator | The subjects will receive the study product and corresponding placebo once a day for 4 weeks in randomised order. There will be a four to five-weeks wash-out between the treatment periods. |
|
| Microcrystalline cellulose | Placebo Comparator | The subjects will receive the study product and corresponding placebo once a day for 4 weeks in randomised order. There will be a four to five-weeks wash-out between the treatment periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epicatechin | Dietary Supplement |
| ||
| Microcrystalline cellulose |
| Measure | Description | Time Frame |
|---|---|---|
| Brachial flow-mediated dilation test (FMD) | ultrasonography, FMDmax% | At first visits of both periods baseline FMD will be recorded followed by FMD recording 1.5 hours after first dose. After 4 weeks intervention, at last visits of both periods FMD will be recorded, last dose will be taken and FMD recorded 1.5 hours after. |
| Measure | Description | Time Frame |
|---|---|---|
| Nitrate-mediated vasodilatation response (NMD) | ultrasonography, NMDmax% | At the first and last visits of both periods, approximately 10 minutes after FMD. |
| Circulating biomarkers of vascular function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirsti Tiihonen, PhD | Danisco | Study Director |
| Olli Raitakari, MD | University of Turku, Turku, Finland, The Research Centre of Applied and Preventive Cardiovascular Medicine | Principal Investigator |
| Pia Salo, MD, PhD | University of Turku, Turku, Finland, The Research Centre of Applied and Preventive Cardiovascular Medicine | Principal Investigator |
| Anne Lithonius | Clinical Research Services Turku | Principal Investigator |
| Mika Scheinin, MD, PhD | Clinical Research Services Turku | Study Chair |
| Jari Turunen, MSc | 4Pharma Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Turku | Turku | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29078780 | Derived | Saarenhovi M, Salo P, Scheinin M, Lehto J, Lovro Z, Tiihonen K, Lehtinen MJ, Junnila J, Hasselwander O, Tarpila A, Raitakari OT. The effect of an apple polyphenol extract rich in epicatechin and flavan-3-ol oligomers on brachial artery flow-mediated vasodilatory function in volunteers with elevated blood pressure. Nutr J. 2017 Oct 27;16(1):73. doi: 10.1186/s12937-017-0291-0. |
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| ID | Term |
|---|---|
| D002392 | Catechin |
| C109691 | microcrystalline cellulose |
| ID | Term |
|---|---|
| D002839 | Chromans |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
depends on the biomarker
| Once at the first visit of both periods and once at the last visit of both periods. Blood sampling prior to the morning dose and appr. 2 h thereafter |
| BP | Once at the first visit of both periods and once at the last visit of both periods. Blood pressure will be recorded twice prior to the morning dose. |
| Plasma epicatechin concentration | HPLC | At the first visit of both periods and at the last visit of both periods. Blood sampling prior to the morning dose and appr. 2 h thereafter |
| D006571 |
| Heterocyclic Compounds |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |