NCT02037308

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable hypertension

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

June 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2014

Completed
Last Updated

January 15, 2014

Status Verified

January 1, 2014

Enrollment Period

4 months

First QC Date

January 13, 2014

Last Update Submit

January 13, 2014

Conditions

Hypertension

Keywords

Glu298Asp polymorphismBlood pressurePlasma NOxBeetroot

Outcome Measures

Primary Outcomes (1)

  • Postprandial blood pressure

    30 minute intervals for a period of 6 hours

Secondary Outcomes (1)

  • Postprandial plasma NOx

    30 minute intervals for a total period of 6 hours

Study Arms (2)

Control white bread

PLACEBO COMPARATOR
Dietary Supplement: Bread

Beetroot bread

EXPERIMENTAL
Dietary Supplement: Bread

Interventions

BreadDIETARY_SUPPLEMENT
Beetroot breadControl white bread

Eligibility Criteria

Age18 Years - 64 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Subjects with anaemia
  • Sufferers of chronic illnesses
  • Individuals with food allergies
  • People with diabetes
  • People with coeliac disease
  • Women
  • Vegetarians

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Food and Nutritional Sciences, University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

Location

Related 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.

    PMID: 23884387BACKGROUND

  • 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.

    PMID: 22414688BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Bread

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Julie Lovegrove, Phd

    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

January 13, 2014

First Posted

January 15, 2014

Study Start

June 1, 2010

Primary Completion

October 1, 2010

Study Completion

December 1, 2012

Last Updated

January 15, 2014

Record last verified: 2014-01

Locations

GB(1)