Impact of Hibiscus on Cardiovascular Disease Risk

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Dietary Supplement: Hibiscus sabdariffa calyces extract as a cold drink

• Registration Number: NCT02165553
• Lead Sponsor: University of Reading

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-06-01
• Study First Submitted QC: 2014-06-13
• Study First Posted: 2014-06-17
• Primary Completion: 2014-08
• Study Completion: 2015-03
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-04
• Last Update Posted: 2015-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hibiscus sabdariffa calyces extract as a cold drink	Hibiscus sabdariffa calyces extract as a cold drink	Subjects are asked to consume 250 ml of Hibiscus calyces drink after a high fat breakfast
Water	Hibiscus sabdariffa calyces extract as a cold drink	Subjects are asked to consume 250 ml of water after a high fat breakfast

Primary Outcome Measures

Name	Time	Method
Change in baseline and hourly blood pressure	Baseline, hourly 4 times post baseline and then hourly for twelve hours at night

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Food and Nutritional Sciences, University of Reading,; 🇬🇧 Reading, Berkshire, United Kingdom