Impact of Hibiscus on Cardiovascular Disease Risk

NCT02165553 | Completed DMC

• 1 other identifier: 13/40
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

Hibiscus sabdariffa calyces; Blood Pressure; Vascular Function; Inflammation; Cardiometabolic risk markers; Systemic antioxidant capacity

Outcome Measures

Primary Outcomes (1)

• Change in baseline and hourly blood pressure

  Baseline, hourly 4 times post baseline and then hourly for twelve hours at night

Secondary Outcomes (6)

• 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

Other Outcomes (2)

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

  Baseline, 2 and 4 hours post treatment

• 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

Study Arms (2)

Hibiscus sabdariffa calyces extract as a cold drink

EXPERIMENTAL

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

Water

PLACEBO COMPARATOR

Subjects are asked to consume 250 ml of water after a high fat breakfast

Dietary Supplement: Hibiscus sabdariffa calyces extract as a cold drink

Interventions

Hibiscus sabdariffa calyces extract as a cold drink DIETARY_SUPPLEMENT

Also known as: Hibiscus flower tea, Hibiscus tea, Roselle

Hibiscus sabdariffa calyces extract as a cold drink; Water

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male
• years
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Reading: lead

Study Sites (1)

Department of Food and Nutritional Sciences, University of Reading,

Reading, Berkshire, RG6 6AP, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Julie A. Lovegrove, BSc, PhD, RNutr

  University of Reading

  PRINCIPAL INVESTIGATOR

• Jeremy P.E. Spencer, B.Sc, PhD

  University of Reading

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 1, 2014
• First Posted: June 17, 2014
• Study Start: January 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: March 1, 2015
• Last Updated: September 7, 2015

Record last verified: 2015-09

Locations

GB (1)