Impact of Hibiscus on Cardiovascular Disease Risk

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Dietary Supplement: Hibiscus sabdariffa calyces extract as a cold drink


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hibiscus sabdariffa calyces extract as a cold drink<br>Subjects are asked to consume 250 ml of Hibiscus calyces drink after a high fat breakfast | Dietary Supplement: Hibiscus sabdariffa calyces extract as a cold drink<br> <br> * Other names: Roselle;|
| Placebo Comparator: Water<br>Subjects are asked to consume 250 ml of water after a high fat breakfast | Dietary Supplement: Hibiscus sabdariffa calyces extract as a cold drink<br> <br> * Other names: Roselle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in baseline and hourly blood pressure |  | Baseline, hourly 4 times post baseline and then hourly for twelve hours at night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Flow Mediated Vasodilation |  | Baseline, 2 and 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 | 
| 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 serum total antioxidant capacity |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hibiscus sabdariffa calyces, Blood Pressure, Vascular Function, Inflammation, Cardiometabolic risk markers, Systemic antioxidant capacity