CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01684930
NCT01684930Phase 2Completed

Increased Plasma Nitrite, Tissue Oxygenation and Functional Changes in PAD

Duke University·interventional·Posted Sep 13, 2012·Updated Aug 29, 2017

In Brief

A Phase 2 clinical trial evaluating Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training and Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training for Peripheral Arterial Disease. Completed, enrolled 32 participants across 1 site.

Detailed Summary

The hypothesis of this proposal is that in subjects with PAD, regular consumption of a high nitrate supplement which raises plasma nitrite, in conjunction with 12 weeks of supervised exercise training at the limb ischemic threshold (SET) will produce a greater clinical benefit (increases in COT and PWT) than placebo plus supervised exercise at the limb ischemic threshold (PET).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 13, 2012
Enrollment StartJun 1, 2012
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 13.8 years ago

Interventions

Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Trainingdrug

The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training.

Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Trainingother

The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training.