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Completed

NCT Number: NCT02735486

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

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

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Key information

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Food and Nutritional Sciences

Reading, Berkshire, RG6 6AP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ginger drink

Dietary Supplement

300 ml ginger drink

Placebo: Super pure water

Dietary Supplement

Placebo: Super pure water

Primary outcomes

  1. Reduction in blood pressure (BP)

    Time frame: Six (6) hours

    Reduction in blood pressure (BP)

Secondary outcomes

  1. Flow mediated dilatation

    Time frame: Six (6) hours

    Improvement in vascular function measured as percentage (%) increase in FMD

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Registry information

Official study title

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

Acronym: G-CVD

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 12, 2016
Registry last updated
Apr 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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