Randomized, Controlled Trial of Ginger Extract Consumption for Healthy Males at Risk of Developing Cardiovascular Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Reading
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Reduction in blood pressure (BP)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
- •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
Arms & Interventions
Ginger drink
Experimental: Ginger drink (300 ml) to be consumed during the study visit
Intervention: Ginger drink (Dietary Supplement)
Placebo: Super pure water
Super Pure water low in nitrate content
Intervention: Placebo: Super pure water (Dietary Supplement)
Outcomes
Primary Outcomes
Reduction in blood pressure (BP)
Time Frame: Six (6) hours
Reduction in blood pressure (BP)
Secondary Outcomes
- Flow mediated dilatation(Six (6) hours)
Investigators
Jeremy Paul Edward Spencer
Professor
University of Reading