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

Cardiovascular Disease Clinical Trial

— G-CVD  

Official title:

Randomized, Controlled Trial of Ginger Extract Consumption for Healthy Males at Risk of Developing Cardiovascular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02735486
• Other study ID #: PHYTOVAS II
• Status: Completed
• Phase: N/A
• First received: December 8, 2015
• Last updated: April 6, 2016
• Start date: February 2014
• Est. completion date: August 2014

Study information

• Verified date: April 2016
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Ginger drink
300 ml ginger drink
• Placebo: Super pure water
Placebo: Super pure water

Locations

Country	Name	City	State
United Kingdom	Department of Food and Nutritional Sciences	Reading	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in blood pressure (BP)	Reduction in blood pressure (BP)	Six (6) hours	No
Secondary	Flow mediated dilatation	Improvement in vascular function measured as percentage (%) increase in FMD	Six (6) hours	No