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Beetroot Enriched Bread, Blood Pressure and Vascular Function

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ClinicalTrials.gov Identifier: NCT01706718
Recruitment Status : Completed
First Posted : October 15, 2012
Last Update Posted : October 15, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Hypertension Dietary Supplement: Bread

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Effects of Beetroot Enriched Bread on Postprandial Vascular Function, Arterial Stiffness and Blood Pressure in Healthy Men
Study Start Date : June 2010
Primary Completion Date : October 2010
Study Completion Date : October 2010
Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Control white bread Dietary Supplement: Bread
Experimental: Beetroot bread Dietary Supplement: Bread


Outcome Measures

Primary Outcome Measures :
  1. Vascular reactivity [ Time Frame: Change from baseline at 2, 4 and 6 hours after bread consumption ]
    Forearm blood flow by Laser Doppler Imaging with iontophoresis


Secondary Outcome Measures :
  1. Arterial stiffness [ Time Frame: Change from baseline at 2, 4 and 6 hours after bread consumption ]
    Pulse wave analysis (PWA) and velocity (PWV)

  2. Blood pressure [ Time Frame: Change from baseline at 30 minute intervals for 7 hours ]
    By ambulatory blood pressure monitor

  3. Plasma nitrate [ Time Frame: Every 30 minutes for 7 hours ]
  4. Plasma nitrite [ Time Frame: Every 30 minutes for 7 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01706718


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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Julie Lovegrove, Professor, University of Reading
ClinicalTrials.gov Identifier: NCT01706718     History of Changes
Other Study ID Numbers: 10/18
University of Reading ( Other Identifier: University of Reading )
First Posted: October 15, 2012    Key Record Dates
Last Update Posted: October 15, 2012
Last Verified: October 2012

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