Impact of Hibiscus on Cardiovascular Disease Risk

NCT ID: NCT02165553

Last Updated: 2015-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-03-31

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.

Detailed Description

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Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Hibiscus sabdariffa calyces extract as a cold drink

Subjects are asked to consume 250 ml of Hibiscus calyces drink after a high fat breakfast

Group Type EXPERIMENTAL

Hibiscus sabdariffa calyces extract as a cold drink

Intervention Type DIETARY_SUPPLEMENT

Water

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

Group Type PLACEBO_COMPARATOR

Hibiscus sabdariffa calyces extract as a cold drink

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Hibiscus sabdariffa calyces extract as a cold drink

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Hibiscus flower tea Hibiscus tea Roselle

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Reading

OTHER

Sponsor Role lead

Responsible Party

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Julie Lovegrove

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julie A. Lovegrove, BSc, PhD, RNutr

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Jeremy P.E. Spencer, B.Sc, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Locations

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Department of Food and Nutritional Sciences, University of Reading,

Reading, Berkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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13/40

Identifier Type: -

Identifier Source: org_study_id

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