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Completed

NCT Number: NCT02165553

Impact of Hibiscus on Cardiovascular Disease Risk

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.

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Key information

Conditions

Cardiovascular Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Food and Nutritional Sciences, University of Reading,

Reading, Berkshire, RG6 6AP, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hibiscus sabdariffa calyces extract as a cold drink

Dietary Supplement

Other names: Hibiscus flower tea, Hibiscus tea, Roselle

Primary outcomes

  1. 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

  1. Change in Flow Mediated Vasodilation

    Time frame: Baseline, 2 and 4 hours post treatment

  2. Change in blood lipids profile

    Time frame: Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment

  3. Change in Inflammatory marker: C - reactive protein (CRP)

    Time frame: Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment

  4. Change in plasma nitric oxide level

    Time frame: Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment

  5. Change in serum total antioxidant capacity

    Time frame: Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment

  6. Changes in serum or plasma glucose and insulin levels

    Time frame: Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment

Other outcomes

  1. Change in arterial stiffness measured by Pulse Wave Analysis (PWA)

    Time frame: Baseline, 2 and 4 hours post treatment

  2. Pharmacokinetics of plasma anthocyanins and phenolic acids measured as Area Under the Concentration - Time Curve (AUC 0 - 4 hours for plasma)

    Time frame: Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Registry information

Official study title

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

Acronym: PHYTOVAS

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jun 17, 2014
Registry last updated
Sep 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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