Glu298Asp Polymorphism and Blood Pressure | NCT02037308

Studies
Glu298Asp Polymorphism and Blood Pressure

NCT02037308

Sponsor

University of Reading

Status

Completed

Last Update Posted

Jan 15, 2014Estimated

Enrollment

14Actual

Phase

Not Applicable

Conditions

Hypertension

Interventions

Bread

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
University of Reading	Other Identifier	University of Reading

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Oct 2010Actual

Completion Date

Dec 2012Actual

First Submitted Date

Jan 13, 2014

First Submission Date that Met QC Criteria

Jan 13, 2014

First Posted Date

Jan 15, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2014

Last Update Posted Date

Jan 15, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control white bread	Placebo Comparator		Dietary Supplement: Bread
Beetroot bread	Experimental		Dietary Supplement: Bread

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bread	Dietary Supplement		Beetroot bread Control white bread

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postprandial blood pressure		30 minute intervals for a period of 6 hours

Secondary Outcomes

Measure	Description	Time Frame
Postprandial plasma NOx		30 minute intervals for a total period of 6 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julie Lovegrove, Phd	University of Reading	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Food and Nutritional Sciences, University of Reading		Reading	Berkshire	RG6 6AP	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23884387	Background	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.
22414688

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages