Recruiting
Phase 1

Inorganic Nitrate

Sponsor:

University of Virginia

Code:

NCT05036213

Conditions

Peripheral Arterial Disease

Peripheral Vascular Diseases

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

BEET IT - Concentrate Beet root juice

BEET IT - Concentrate Beet root juice (nitrate depleted)

Study Details

Brief summary:

Peripheral arterial disease (PAD) is a highly prevalent and costly condition. Intermittent claudication (IC), defined as ischemic leg pain that occurs with walking, results in functional impairment, reduced daily physical activity, and a lower quality of life. Although the mechanisms contributing to functional impairment are not fully delineated, current evidence suggests that the uncoupling of skeletal muscle cellular metabolism from tissue perfusion may be responsible for exercise intolerance. We have previously shown increases in plasma inorganic nitrite, via oral nitrate, produced clinically significant increases exercise performance in patients with PAD+IC.

The hypothesis of this proposal is in patients with PAD+IC, 3-6 days of oral dietary nitrate consumption (in the form of concentrated beetroot juice) will produce a greater tissue perfusion, oxygen delivery, and enhanced muscle metabolism in comparison to placebo. This will translate into an increase in physical performance in both muscle specific plantar flexion exercise and treadmill measures of pain free ambulation. In order to test this hypothesis, we will recruit 10 patients PAD+IC in a randomized, double-blind, placebo controlled, cross over design.

Conditions

Peripheral Arterial Disease

Peripheral Vascular Diseases

Study ID

NCT05036213

Start date

Feb 1, 2020

Status verified date

Nov, 2023

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • - History of stable intermittent claudication for 3 or more months, and an Ankle-brachial index test (ABI) <0.9 at rest.
  • Symptomatic PAD (claudication or critical limb ischemia)

Exclusion Criteria:

  • - Limb threatening ischemia, including rest pain and/or gangrene; impending limb loss or chronic osteomyelitis.
  • Lower extremity vascular surgery, angioplasty or lumbar sympathectomy within 3 months of enrollment;
  • severe peripheral neuropathy or any condition other than PAD that limits walking such as unstable angina;
  • history of significant left main or three vessel coronary artery disease (>70% stenosis, unprotected by grafts) or recent myocardial infarction (6 weeks);
  • chest pain during treadmill exercise which appears before the onset of claudication,
  • chronic renal failure with an eGRF<30; Type 1diabetes mellitus, a BMI>40, and a HbA1c>8.5%. Refusal to give or inability to give informed consent. Pregnancy (Self-reported).

Study Design

Enrollment

28 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Dietary nitrate

The active treatment, beetroot juice (BEET IT, James White Drinks, Ipswich, UK), contains 6.2mmol of inorganic nitrate. Participants will continue supplementation until they complete all testing visits.

placebo comparator: concentrated beet root juice with depleted nitrate content

The placebo treatment is also beetroot juice provide by the same company (BEET IT, James White Drinks, Ipswich, UK), but it does not contain any inorganic nitrate. Participants will continue supplementation until they complete all testing visits.

Interventions

BEET IT - Concentrate Beet root juice

Each bottle contains 75ml of concentrated beetroot juice with approximately 6.2mmol of inorganic nitrate. The product is provided by BEET IT, James White Drinks, Ipswich, UK.

BEET IT - Concentrate Beet root juice (nitrate depleted)

Each bottle contains 75ml of concentrated beetroot juice with depleted nitrate, thus, no inorganic nitrate is found in thisbeverage. The product is also provided by BEET IT, James White Drinks, Ipswich, UK.

Primary outcome measure

  • Phosphocreatine kinetics after maximal exercise [ Time Frame: After a minimum of 3 days of supplementation with either Placebo or nitrate rich beverage. ]

Central Contacts and Locations

Central contacts

Casey C Derella, PhD

434-243-8677bxg7vn@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Jason D. Allen, PhD

434-243-0736ja6af@virginia.edu

Principal Investigator:

Christopher M. Kramer, MD

More Information

Sponsor

University of Virginia

Last update posted

Nov 29, 2023

Last verified

Nov, 2023

Keywords

  • PAD
  • nitrate
  • nitric oxide

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2023-11-29.