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Creatine monohydrate for Peripheral Arterial Disease

Phase 2

Waitlist Available

Led By Judy Muller-Delp, Ph.D.

Research Sponsored by Florida State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Summary

This trial tests if a muscle stretching device and creatine supplement can help older adults and PAD patients exercise better by improving blood flow and muscle energy. Creatine supplementation has been studied extensively and shown to improve muscle performance and strength in older adults.

Eligible Conditions

Peripheral Arterial Disease
Peripheral Artery Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Walking tolerance

Secondary study objectives

Magnetic Resonance Imaging (MRI)

Near infrared spectroscopy (NIRS)

Side effects data

From 2015 Phase 4 trial • 14 Patients • NCT01514630

71%

Cold and flu symptoms

29%

Diarrhea

21%

Stomach Discomfort

14%

Muscle Cramps

Lightheaded

Indigestion

Polydipsia

Headache

Swelling in Hands

Numbness and Tingling in hands

Nausea

100%

80%

60%

40%

20%

Study treatment Arm

Creatine Monohydrate

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Creatine monohydrateExperimental Treatment1 Intervention

Creatine Monohydrate will be given at a 5 day loading period (10g/day) followed by a maintenance phase (5 g/day). The objectives of the current trial are to investigate if creatine supplementation plus muscle stretching improves 6-minute walking distance and muscle oxygenation in patients with peripheral artery disease.

Group II: CellulosePlacebo Group1 Intervention

These participants will consume a fiber supplement in place of creatine monohydrate at a matched dose with muscle stretching.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Creatine monohydrate

2005

Completed Phase 4

~670

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