Acute Impact of Hibiscus Sabdariffa Calyces (HSC) Extract Consumption on Blood Pressure, Vascular Function and Other Cardiovascular Risk Factors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Reading
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- Change in baseline and hourly blood pressure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •<30 or > 65 years
- •<1 or >10 % Cardiovascular disease risk in 10 years
- •Taking blood pressure medication
- •Having liver or kidney disease
- •Lack of signing consent form
- •Individual with food allergy
- •Sufferers of chronic illness
Outcomes
Primary Outcomes
Change in baseline and hourly blood pressure
Time Frame: Baseline, hourly 4 times post baseline and then hourly for twelve hours at night
Secondary Outcomes
- Change in Flow Mediated Vasodilation(Baseline, 2 and 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)
- 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 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)
- 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)
Investigators
Julie Lovegrove
Professor
University of Reading