- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02037308
Glu298Asp Polymorphism and Blood Pressure
January 13, 2014 updated by: Julie Lovegrove, University of Reading
The Effects of Beetroot Bread on Postprandial Blood Pressure According to Glu298Asp Polymorphism in the eNOS Gene
The Glu298Asp polymorphism has been linked to increased risk of cardiovascular events, proposed to be due to reduced nitric oxide production by eNOS reported in some but not all studies.
We hypothesise that beetroot-enriched bread interacts with the Glu298Asp polymorphism of the eNOS gene to lower blood pressure and increase plasma nitrate/nitrite, particularly in carriers of the T allele, which have been associated with lower eNOS activity and increased risk of hypertension.
Study Overview
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Berkshire
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Reading, Berkshire, United Kingdom, RG6 6AP
- Food and Nutritional Sciences, University of Reading
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male
- A signed consent form
- Age 18-64 years
- Body mass index - 18.5-30 kg/m2
- Non-smoking, healthy individuals
- Normal blood pressure at screening (< 150/90)
Exclusion Criteria:
- Subjects with anaemia
- Sufferers of chronic illnesses
- Individuals with food allergies
- People with diabetes
- People with coeliac disease
- Women
- Vegetarians
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control white bread
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|
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Experimental: Beetroot bread
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Postprandial blood pressure
Time Frame: 30 minute intervals for a period of 6 hours
|
30 minute intervals for a period of 6 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Postprandial plasma NOx
Time Frame: 30 minute intervals for a total period of 6 hours
|
30 minute intervals for a total period of 6 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Julie Lovegrove, PhD, University of Reading
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hobbs DA, Goulding MG, Nguyen A, Malaver T, Walker CF, George TW, Methven L, Lovegrove JA. Acute ingestion of beetroot bread increases endothelium-independent vasodilation and lowers diastolic blood pressure in healthy men: a randomized controlled trial. J Nutr. 2013 Sep;143(9):1399-405. doi: 10.3945/jn.113.175778. Epub 2013 Jul 24.
- Hobbs DA, Kaffa N, George TW, Methven L, Lovegrove JA. Blood pressure-lowering effects of beetroot juice and novel beetroot-enriched bread products in normotensive male subjects. Br J Nutr. 2012 Dec 14;108(11):2066-74. doi: 10.1017/S0007114512000190. Epub 2012 Mar 14.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
January 13, 2014
First Submitted That Met QC Criteria
January 13, 2014
First Posted (Estimate)
January 15, 2014
Study Record Updates
Last Update Posted (Estimate)
January 15, 2014
Last Update Submitted That Met QC Criteria
January 13, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10/18G
- University of Reading (Other Identifier: Reading University)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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