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

Tracking Information
First Received Date ^ICMJE	September 27, 2012
Last Updated Date	October 12, 2012
Start Date ^ICMJE	June 2010
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 12, 2012)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01706718 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 12, 2012)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Beetroot Enriched Bread, Blood Pressure and Vascular Function
Official Title ^ICMJE	The Effects of Beetroot Enriched Bread on Postprandial Vascular Function, Arterial Stiffness and Blood Pressure in Healthy Men
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
Condition ^ICMJE	Hypertension
Intervention ^ICMJE	Dietary Supplement: Bread
Study Arm (s)	Placebo Comparator: Control white bread Intervention: Dietary Supplement: Bread Experimental: Beetroot bread Intervention: Dietary Supplement: Bread
Publications *	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 Mar 14:1-9. [Epub ahead of print]
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	24
Completion Date	October 2010
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	18 Years to 64 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01706718
Other Study ID Numbers ^ICMJE	10/18, University of Reading
Has Data Monitoring Committee	Yes
Responsible Party	Julie Lovegrove, University of Reading
Study Sponsor ^ICMJE	University of Reading
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Reading
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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