Cardiovascular Diseases
Conditions
Keywords
Hibiscus sabdariffa calyces, Blood Pressure, Vascular Function, Inflammation, Cardiometabolic risk markers, Systemic antioxidant capacity
Brief summary
Hibiscus sabdariffa calyces (HSC) extract is consumed in different parts of the world as a cold or hot drink and is available in the United Kingdom (UK) markets in different forms including tea bags. There is preliminary data that support the hypothesis that HSC extract consumption has beneficial effect on blood vessel health and blood pressure reduction. Hypertension, vascular dysfunction, inflammation and lipid abnormalities are all key modifiable risk factors of cardiovascular diseases (CVD), the leading causes of death throughout the world. In the PHYTOVAS (PHYTOchemicals and VAScular Function) study the effect of the acute consumption a potentially bioactive food extracts: Hibiscus sabdariffa calyces (HSC) compared with a matched control (water) on blood pressure and blood vessels function will be investigated after a high - fat mixed meal. This is with a view to determining the impacts of the extract on postprandial (after meal) blood pressure and other CVD risk factors. Results from the PHYTOVAS study could lead to identification of more dietary approaches that will contribute to CVD risk prevention and management.
Interventions
DIETARY_SUPPLEMENTHibiscus sabdariffa calyces extract as a cold drink
Sponsors
University of Reading
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male * 30 - 65 years * 1 to 10 % Cardiovascular disease risk in 10 years * Not taking blood pressure medication * Not having liver or kidney disease * Not anaemic * A signed consent form
Exclusion criteria
* Female * \<30 or \> 65 years * \<1 or \>10 % Cardiovascular disease risk in 10 years * Taking blood pressure medication * Having liver or kidney disease * Anaemic * Lack of signing consent form * Vegan * Individual with food allergy * Sufferers of chronic illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in baseline and hourly blood pressure | Baseline, hourly 4 times post baseline and then hourly for twelve hours at night |
Secondary
| Measure | Time frame |
|---|---|
| Change in blood lipids profile | Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment |
| Change in Inflammatory marker: C - reactive protein (CRP) | Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment |
| Change in plasma nitric oxide level | Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment |
| Change in Flow Mediated Vasodilation | Baseline, 2 and 4 hours post treatment |
| Changes in serum or plasma glucose and insulin levels | Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment |
| Change in serum total antioxidant capacity | Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment |
Other
| Measure | Time frame |
|---|---|
| Pharmacokinetics of plasma anthocyanins and phenolic acids measured as Area Under the Concentration - Time Curve (AUC 0 - 4 hours for plasma) | Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment |
| Change in arterial stiffness measured by Pulse Wave Analysis (PWA) | Baseline, 2 and 4 hours post treatment |
Countries
United Kingdom
Outcome results
None listed