NCT02735486

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
Last Updated

April 12, 2016

Status Verified

April 1, 2016

Enrollment Period

6 months

First QC Date

December 8, 2015

Last Update Submit

April 6, 2016

Conditions

Cardiovascular Disease

Keywords

Gingerblood pressureflow mediated dilatation

Outcome Measures

Primary Outcomes (1)

  • Reduction in blood pressure (BP)

    Reduction in blood pressure (BP)

    Six (6) hours

Secondary Outcomes (1)

  • Flow mediated dilatation

    Six (6) hours

Study Arms (2)

Ginger drink

EXPERIMENTAL

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

Dietary Supplement: Ginger drink

Placebo: Super pure water

PLACEBO COMPARATOR

Super Pure water low in nitrate content

Dietary Supplement: Placebo: Super pure water

Interventions

Ginger drinkDIETARY_SUPPLEMENT

300 ml ginger drink

Ginger drink
Placebo: Super pure waterDIETARY_SUPPLEMENT

Placebo: Super pure water

Placebo: Super pure water

Eligibility Criteria

Age30 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Food and Nutritional Sciences

Reading, Berkshire, RG6 6AP, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Jeremy PE Spencer, Professor

    University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 8, 2015

First Posted

April 12, 2016

Study Start

February 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

April 12, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)