Northern Board Beet Breathlessness Trial | NCT01610024

Studies
Northern Board Beet Breathlessness Trial

NCT01610024

Sponsor

Northern Health and Social Care Trust

Status

Unknown status

Last Update Posted

Jun 26, 2013Estimated

Enrollment

8Estimated

Phase

Phase 1

Conditions

Exercise Tolerance (Measured in Minutes)

Interventions

Beetroot Juice

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

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Oct 2013Estimated

Completion Date

Nov 2013Estimated

First Submitted Date

May 30, 2012

First Submission Date that Met QC Criteria

May 30, 2012

First Posted Date

Jun 1, 2012Estimated

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

Jun 25, 2013

Last Update Posted Date

Jun 26, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Wendy Anderson, Consultant Respiratory Physician, Northern Health and Social Care TrustPrincipal Investigator

Lead Sponsor

Northern Health and Social Care TrustOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Hypothesis: Beetroot juice increases the exercise tolerance of patients with chronic lung disease.

Using the already established pulmonary rehabilitation model, we aim to split the group of 8 into 2 groups, each group taking 500ml of beetroot juice 24 hours before there class on alternate (differing) weeks to see if it improves their overall exercise tolerance.

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Beetroot	Active Comparator		Dietary Supplement: Beetroot Juice

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Beetroot Juice	Dietary Supplement	Give subjects 500ml beetroot juice in the 24 hour period prior to class begins. They will receive this during 3 of the 6 weeks	Beetroot

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Exercise Tolerance	Measuring incremental change in exercise tolerance between weeks of beetroot consumption and weeks of no beetroot consumption	6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Already planned to attend the pulmonary rehabilitation class

Exclusion Criteria:

Angina Prescribed regular nitrates, a resting heart rate >100bpm, a resting blood pressure <110 systolic, postural hypotension, prescribed PDE5 inhibitors.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wendy Anderson, MBBCh	Contact	0044 2894424000		Wendy.Anderson@northerntrust.hscni.net

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Antrim Area Hospital	Recruiting	Antrim	County Antrim	BT41 2RL	United Kingdom