Acute Effects of Ginger Extract Consumption on Risk Markers of Cardiovascular Disease

NCT ID: NCT02735486

Last Updated: 2016-04-12

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

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-08-31

Brief Summary

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The primary aim of the study was to investigate the acute effect of ginger drink consumption on the risk markers of cardiovascular disease.

Detailed Description

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A randomized, single-blind human intervention study involving 22 healthy male volunteers was designed to investigate the acute effects of ginger drink consumption on risk markers of cardiovascular disease (CVD). The primary outcome measure is reduction in blood pressure while the secondary outcome measures are improvement in flow mediated dilatation (FMD) and changes in plasma biochemical profile parameters related to CVD. Participants were given 300 ml of ginger extract or water (placebo) with breakfast, followed by a lunch at 2 hours on two visits separated by 2 weeks. Blood and urine samples were collected at regular intervals as well as blood pressure measurement done during the two visits. Vascular function was measured by flow mediated dilatation (FMD) and pulse wave velocity (PWV) at baseline, 2 and 4 hours after the the consumption of the study drink and placebo. The blood and urine samples were analysed for changes in lipid profile and other markers of CVD.

Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Ginger drink

Experimental: Ginger drink (300 ml) to be consumed during the study visit

Group Type EXPERIMENTAL

Ginger drink

Intervention Type DIETARY_SUPPLEMENT

300 ml ginger drink

Placebo: Super pure water

Super Pure water low in nitrate content

Group Type PLACEBO_COMPARATOR

Placebo: Super pure water

Intervention Type DIETARY_SUPPLEMENT

Placebo: Super pure water

Interventions

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Ginger drink

300 ml ginger drink

Intervention Type DIETARY_SUPPLEMENT

Placebo: Super pure water

Placebo: Super pure water

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Apparently healthy males,
* Age (30 - 65) years,
* Not diabetic or plasma glucose \> 7 or on anti-diabetic drugs and not on anti- hypertensive drugs.
* Subjects \< 10% risk of cardiovascular disease

Exclusion Criteria

* Women,
* Men younger than 30 years and older that 65 years,
* Men who are sick or on anti-diabetic and anti-hypertensive drugs.
* Men who have history of heart attack or stroke within the last 12 months
* Men who are on lipids lowering drugs
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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Jeremy Paul Edward Spencer

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeremy PE Spencer, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Locations

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Department of Food and Nutritional Sciences

Reading, Berkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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PHYTOVAS II

Identifier Type: -

Identifier Source: org_study_id

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