NCT01706718

Brief Summary

Dietary nitrate is known to lower blood pressure. Beetroot is a rich source of nitrate and could therefore be an important dietary component in the management of hypertension and cardiovascular disease, however consumption is relatively low. We evaluated the effects of beetroot enriched bread ingestion on acute microvascular reactivity, arterial stiffness and blood pressure response in healthy men.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Jun 2010

Shorter than P25 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
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 15, 2012

Completed
Last Updated

October 15, 2012

Status Verified

October 1, 2012

Enrollment Period

4 months

First QC Date

September 27, 2012

Last Update Submit

October 12, 2012

Conditions

Keywords

BeetrootBlood pressureVascular function

Outcome Measures

Primary Outcomes (1)

  • Vascular reactivity

    Forearm blood flow by Laser Doppler Imaging with iontophoresis

    Change from baseline at 2, 4 and 6 hours after bread consumption

Secondary Outcomes (4)

  • Arterial stiffness

    Change from baseline at 2, 4 and 6 hours after bread consumption

  • Blood pressure

    Change from baseline at 30 minute intervals for 7 hours

  • Plasma nitrate

    Every 30 minutes for 7 hours

  • Plasma nitrite

    Every 30 minutes for 7 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)

University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

Location

Related Publications (2)

  • 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
  • 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.

MeSH Terms

Conditions

Hypertension

Interventions

Bread

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

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

Study Record Dates

First Submitted

September 27, 2012

First Posted

October 15, 2012

Study Start

June 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

October 15, 2012

Record last verified: 2012-10

Locations