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

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.

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

Conditions
-----------------
Cardiovascular Disease

Intervention / Treatment
-----------------
* Dietary Supplement: Ginger drink
* Dietary Supplement: Placebo: Super pure water


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ginger drink<br>Experimental: Ginger drink (300 ml) to be consumed during the study visit | Dietary Supplement: Ginger drink<br>* 300 ml ginger drink<br>|
| Placebo Comparator: Placebo: Super pure water<br>Super Pure water low in nitrate content | Dietary Supplement: Placebo: Super pure water<br>* Placebo: Super pure water<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in blood pressure (BP) | Reduction in blood pressure (BP) | Six (6) hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow mediated dilatation | Improvement in vascular function measured as percentage (%) increase in FMD | Six (6) hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ginger, blood pressure, flow mediated dilatation