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Beetroot Enriched Bread, Blood Pressure and Vascular Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Julie Lovegrove, University of Reading
ClinicalTrials.gov Identifier:
NCT01706718
First received: September 27, 2012
Last updated: October 12, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Hypertension
 Dietary Supplement: Bread

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: The Effects of Beetroot Enriched Bread on Postprandial Vascular Function, Arterial Stiffness and Blood Pressure in Healthy Men

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Reading:

Primary Outcome Measures:
  • Vascular reactivity [ Time Frame: Change from baseline at 2, 4 and 6 hours after bread consumption ] [ Designated as safety issue: No ]
    Forearm blood flow by Laser Doppler Imaging with iontophoresis


Secondary Outcome Measures:
  • Arterial stiffness [ Time Frame: Change from baseline at 2, 4 and 6 hours after bread consumption ] [ Designated as safety issue: No ]
    Pulse wave analysis (PWA) and velocity (PWV)

  • Blood pressure [ Time Frame: Change from baseline at 30 minute intervals for 7 hours ] [ Designated as safety issue: No ]
    By ambulatory blood pressure monitor

  • Plasma nitrate [ Time Frame: Every 30 minutes for 7 hours ] [ Designated as safety issue: No ]
  • Plasma nitrite [ Time Frame: Every 30 minutes for 7 hours ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: June 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control white bread Dietary Supplement: Bread
Experimental: Beetroot bread Dietary Supplement: Bread

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706718

Locations
United Kingdom
University of Reading
Reading, Berkshire, United Kingdom, RG6 6AP
Sponsors and Collaborators
University of Reading
  More Information

Publications:

Responsible Party: Julie Lovegrove, Professor, University of Reading
ClinicalTrials.gov Identifier: NCT01706718     History of Changes
Other Study ID Numbers: 10/18, University of Reading
Study First Received: September 27, 2012
Last Updated: October 12, 2012
Health Authority: United Kingdom: Food Standards Agency

Keywords provided by University of Reading:
Beetroot
Blood pressure
Vascular function

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013