Clinical trial NCT02165553: Impact of Hibiscus on Cardiovascular Disease Risk
Official title: Acute Impact of Hibiscus Sabdariffa Calyces (HSC) Extract Consumption on Blood Pressure, Vascular Function and Other Cardiovascular Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Hibiscus sabdariffa calyces
Blood Pressure
Vascular Function
Inflammation
Cardiometabolic risk markers
Systemic antioxidant capacity
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2014-06-17
Enrollment: 25
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in baseline and hourly blood pressure
timeFrame: Baseline, hourly 4 times post baseline and then hourly for twelve hours at night
Secondary outcomes:
measure: Change in Flow Mediated Vasodilation
timeFrame: Baseline, 2 and 4 hours post treatment
measure: Change in blood lipids profile
timeFrame: Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment
measure: Change in Inflammatory marker: C - reactive protein (CRP)
timeFrame: Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment
measure: Change in plasma nitric oxide level
timeFrame: Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment
measure: Change in serum total antioxidant capacity
timeFrame: Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment
measure: Changes in serum or plasma glucose and insulin levels
timeFrame: Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment
Other outcomes:
measure: Change in arterial stiffness measured by Pulse Wave Analysis (PWA)
timeFrame: Baseline, 2 and 4 hours post treatment
measure: Pharmacokinetics of plasma anthocyanins and phenolic acids measured as Area Under the Concentration - Time Curve (AUC 0 - 4 hours for plasma)
timeFrame: Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment
Locations:
city: Reading
country: United Kingdom
facility: Department of Food and Nutritional Sciences, University of Reading,
state: Berkshire
Study officials:
affiliation: University of Reading
name: Julie A. Lovegrove, BSc, PhD, RNutr
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Reading
name: Jeremy P.E. Spencer, B.Sc, PhD
role: PRINCIPAL_INVESTIGATOR
References: