Borderline Hypertension
Conditions
Keywords
FMD, epicatechin, apple polyphenol, borderline hypertension
Brief summary
Effect of apple polyphenols on FMD.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTEpicatechin
DIETARY_SUPPLEMENTMicrocrystalline cellulose
Sponsors
University of Turku
4Pharma Ltd.
Danisco
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Borderline hypertension * Otherwise healthy * Aged 40-65 years (inclusive) * Not consuming high amounts (over 20 mg daily) of flavonoids
Exclusion criteria
* BMI \>32 kg/m2 * Total serum cholesterol ≥ 8 mmol/l * Any abnormal safety laboratory parameter or abnormal finding in ECG evaluated to be clinically significant * Coronary artery disease * Pregnancy or lactating * Alcohol abuse as evaluated by medical history * Regular smoking/using nicotine products * Diabetes mellitus * Apple allergy * Use of lipid lowering medications * Regular use of any medication that is known or believed to affect endothelial function or blood vessel constriction * Any other condition or medication that in the opinion of the investigator would interfere with the evaluation of the study results or constitute a health risk for the subject * High consumption of vitamin products, herbal remedies or products containing flavonoids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brachial flow-mediated dilation test (FMD) | 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. | ultrasonography, FMDmax% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nitrate-mediated vasodilatation response (NMD) | At the first and last visits of both periods, approximately 10 minutes after FMD. | ultrasonography, NMDmax% |
| Circulating biomarkers of vascular function | 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 | depends on the biomarker |
| 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 | 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 | HPLC |
Countries
Finland
Outcome results
None listed