ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615000906550

Ethics application status

Approved

Date submitted

5/08/2015

Date registered

1/09/2015

Date last updated

20/07/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Effects of Dietary Inorganic Nitrate Supplementation on Exercise Performance in Heart Failure

Scientific title

Effects of Dietary Inorganic Nitrate Supplementation on Exercise Performance in Heart Failure

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Heart Failure Preserved Ejection Fraction (HFpEF)

Heart Failure Reduced Ejection Fraction (HFrEF)

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

All participants will consume 210mL of inorganic beetroot juice per day:
-Two 70mL bottles of inorganic beetroot juice
-One 70mL bottle of sport inorganic beetroot juice)
Beetroot juice is sourced from :BEET IT shot, James White Drinks, Ipswich, UK

Participants will consume the the sport shot in the morning, and one of each of the other two bottles midday and at night. The sport shot contains approximately 6.4mmol of nitrate and each organic shot contains approximately 4.8mmol of nitrate per bottle, with a total daily dosing of 16mmol nitrate.

Participants will be required to have at least 7 days of supplementation with the beetroot juice, but depending on subject availability, the total days dosing could vary between subjects. One subject might have availability to complete all round 1 testing visits within a week, whereas another subject could require a week and a half to complete all visits. Previous research does not indicate any further benefits of nitrate dosing beyond 6 days, so we do not expect the total days dosing to affect the study outcome providing all subjects meet the minimum of 7 days supplementation.

Following supplementation, subjects will undergo a minimum of two week wash-out period.

Adherence will be managed by reminder phone calls to subjects during the supplementation period. They will also be asked to keep a record of when they consumed the supplement. and return the empty bottles to the research team.

Intervention code [1]

Treatment: Other

Intervention code [2]

Lifestyle

Comparator / control treatment

Participants will consume 140mL (two 70mL bottles) of the placebo beetroot juice twice per day for 7-10 days.

The placebo has been specifically manufactured by James White Drinks, Ipswich, UK, to be identical to the active drink, with the only difference between the two being that the placebo has been made inactive by removing the nitrate.

The study employs a cross-over design so all participants will supplement with both the beetroot juice and the placebo, with the order of supplementation randomized, and the dosing remaining double-blinded.

Control group

Placebo

Outcomes

Primary outcome [1]

To determine group differences in VO2peak during a maximal graded treadmill cardiopulmonary exercise test (CPX) following beetroot juice (BTR) or placebo (PL) treatment both within and between the heart failure groups.

VO2peak will be determined via using a metabolic cart.

Timepoint [1]

During the screening visit participants will complete a maximal CPX. The VO2peak obtained from this test, however, will not be used in final analysis. This screening visit will be used to determine the appropriate workloads for the testing CPX visits and will act as a familiarisation for the participants.

VO2peak will be assessed following a minimum of 7 days of beetroot juice supplementation and again following a minimum of 7 days placebo supplementation.

Primary outcome [2]

To determine group differences in time to exhaustion during a maximal graded treadmill cardiopulmonary exercise test (CPX) following beetroot juice (BTR) or placebo (PL) treatment both within and between the heart failure groups.

Timepoint [2]

During the screening visit participants will complete a maximal CPX. The time to exhaustion obtained from this test, however, will not be used in final analysis. This screening visit will be used to determine the appropriate workloads for the testing CPX visits and will act as a familiarisation for the participants.

Time to exhaustion will be assessed following a minimum of 7 days of beetroot juice supplementation and again following a minimum of 7 days placebo supplementation.

Primary outcome [3]

To determine the segment of Heart Failure patients that can achieve the desired level of plasma nitrite (>400nM) over the course of the 7-10 day dosing regimen.

Timepoint [3]

Plasma nitrite levels in response to the nitrate supplementation will be assessed following a minimum of 7 days of nitrate dosing.

Blood samples will be taken at the maximal CPX and vascular testing visits following both placebo and nitrate dosing. To assess plasma nitrite concentrations, however, only the blood data collected following nitrate supplementation will be required.

Secondary outcome [1]

To determine group differences between HFpEF and HFrEF in exercise tissue oxygenation (by NIRS) following BTR or PL treatment.

Timepoint [1]