Impact of Hibiscus on Cardiovascular Disease Risk

Cardiovascular Diseases Clinical Trial

— PHYTOVAS  

Official title:

Acute Impact of Hibiscus Sabdariffa Calyces (HSC) Extract Consumption on Blood Pressure, Vascular Function and Other Cardiovascular Risk Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02165553
• Other study ID #: 13/40
• Status: Completed
• Phase: N/A
• First received: June 1, 2014
• Last updated: September 4, 2015
• Start date: January 2014
• Est. completion date: March 2015

Study information

• Verified date: September 2015
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: University of Reading
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Hibiscus sabdariffa calyces extract as a cold drink

Locations

Country	Name	City	State
United Kingdom	Department of Food and Nutritional Sciences, University of Reading,	Reading	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in arterial stiffness measured by Pulse Wave Analysis (PWA)		Baseline, 2 and 4 hours post treatment	No
Other	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	No
Primary	Change in baseline and hourly blood pressure		Baseline, hourly 4 times post baseline and then hourly for twelve hours at night	No
Secondary	Change in Flow Mediated Vasodilation		Baseline, 2 and 4 hours post treatment	No
Secondary	Change in blood lipids profile		Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment	No
Secondary	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	No
Secondary	Change in plasma nitric oxide level		Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment	No
Secondary	Change in serum total antioxidant capacity		Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment	No
Secondary	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	No