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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02037308
Other study ID # 10/18G
Secondary ID University of Re
Status Completed
Phase N/A
First received January 13, 2014
Last updated January 13, 2014
Start date June 2010
Est. completion date December 2012

Study information

Verified date January 2014
Source University of Reading
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Food Standards Agency
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date December 2012
Est. primary completion date October 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 64 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Bread


Locations

Country Name City State
United Kingdom Food and Nutritional Sciences, University of Reading Reading Berkshire

Sponsors (1)

Lead Sponsor Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Postprandial blood pressure 30 minute intervals for a period of 6 hours No
Secondary Postprandial plasma NOx 30 minute intervals for a total period of 6 hours No
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