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

Not Applicable

Completed

• Conditions: Cardiovascular Disease
• Interventions: Dietary Supplement: Ginger drink

• Registration Number: NCT02735486
• Lead Sponsor: University of Reading

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Study First Submitted: 2015-12-08
• Status Verified: 2016-04
• Study First Submitted QC: 2016-04-06
• Last Update Submitted: 2016-04-06
• Study First Posted: 2016-04-12
• Last Update Posted: 2016-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Reduction in blood pressure (BP)	Six (6) hours	Reduction in blood pressure (BP)

Secondary Outcome Measures

Name	Time	Method
Flow mediated dilatation	Six (6) hours	Improvement in vascular function measured as percentage (%) increase in FMD

Trial Locations

Locations (1)

Department of Food and Nutritional Sciences; 🇬🇧 Reading, Berkshire, United Kingdom