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Impact of Hibiscus on Cardiovascular Disease Risk (PHYTOVAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02165553
Recruitment Status : Completed
First Posted : June 17, 2014
Last Update Posted : September 7, 2015
Sponsor:
Information provided by (Responsible Party):
Julie Lovegrove, 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Dietary Supplement: Hibiscus sabdariffa calyces extract as a cold drink Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Acute Impact of Hibiscus Sabdariffa Calyces (HSC) Extract Consumption on Blood Pressure, Vascular Function and Other Cardiovascular Risk Factors
Study Start Date : January 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : March 2015

Arm Intervention/treatment
Experimental: Hibiscus sabdariffa calyces extract as a cold drink
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
Other Names:
  • Hibiscus flower tea
  • Hibiscus tea
  • Roselle

Placebo Comparator: Water
Subjects are asked to consume 250 ml of water after a high fat breakfast
Dietary Supplement: Hibiscus sabdariffa calyces extract as a cold drink
Other Names:
  • Hibiscus flower tea
  • Hibiscus tea
  • Roselle




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02165553


Locations
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United Kingdom
Department of Food and Nutritional Sciences, University of Reading,
Reading, Berkshire, United Kingdom, RG6 6AP
Sponsors and Collaborators
University of Reading
Investigators
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Principal Investigator: Julie A. Lovegrove, BSc, PhD, RNutr University of Reading
Principal Investigator: Jeremy P.E. Spencer, B.Sc, PhD University of Reading
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Responsible Party: Julie Lovegrove, Professor, University of Reading
ClinicalTrials.gov Identifier: NCT02165553    
Other Study ID Numbers: 13/40
First Posted: June 17, 2014    Key Record Dates
Last Update Posted: September 7, 2015
Last Verified: September 2015
Keywords provided by Julie Lovegrove, University of Reading:
Hibiscus sabdariffa calyces
Blood Pressure
Vascular Function
Inflammation
Cardiometabolic risk markers
Systemic antioxidant capacity
Additional relevant MeSH terms:
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Cardiovascular Diseases