Trial Outcomes & Findings for Creatine Use and Muscle Stretching in Peripheral Artery Disease (NCT NCT04471792)

Results Overview

6-minute walking test. This test measures the distance (in meters) that a patient can walk in 6 minutes.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Baseline and after 4 weeks of intervention

Results posted on

2025-12-08

Participant Flow

33 patients were screened. 3 patients were ineligible due to kidney disease and resting leg pain. Thirty patients met eligibility criteria. 8 patients did not respond to follow up and 9 patients lost interest. 13 patients consented to participate and were randomly assigned to either stretch+creatine or stretch+placebo. Zero healthy control participants were enrolled. Only participants with Peripheral Artery Disease were enrolled and randomized to either stretch+creatine or stretch+placebo."

All 13 patients that were consented completed baseline testing and randomization to either stretch +creatine or stretch + placebo.

Participant milestones

Participant milestones
Measure	Creatine Monohydrate 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. Creatine monohydrate: Creatine monohydrate will be used in combination with muscle stretching.	Cellulose These participants will consume a fiber supplement in place of creatine monohydrate at a matched dose with muscle stretching. Cellulose: Cellulose will be used in combination with muscle stretching.
Overall Study STARTED	7	6
Overall Study COMPLETED	7	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Creatine Monohydrate n=7 Participants 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. Creatine monohydrate: Creatine monohydrate will be used in combination with muscle stretching.	Cellulose n=6 Participants These participants will consume a fiber supplement in place of creatine monohydrate at a matched dose with muscle stretching. Cellulose: Cellulose will be used in combination with muscle stretching.	Total n=13 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=13 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=7 Participants	1 Participants n=6 Participants	2 Participants n=13 Participants
Age, Categorical >=65 years	6 Participants n=7 Participants	5 Participants n=6 Participants	11 Participants n=13 Participants
Sex: Female, Male Female	3 Participants n=7 Participants	3 Participants n=6 Participants	6 Participants n=13 Participants
Sex: Female, Male Male	4 Participants n=7 Participants	3 Participants n=6 Participants	7 Participants n=13 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	7 Participants n=7 Participants	6 Participants n=6 Participants	13 Participants n=13 Participants

PRIMARY outcome

Timeframe: Baseline and after 4 weeks of intervention

6-minute walking test. This test measures the distance (in meters) that a patient can walk in 6 minutes.

Outcome measures

Outcome measures
Measure	Creatine Monohydrate n=7 Participants 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. Creatine monohydrate: Creatine monohydrate will be used in combination with muscle stretching.	Cellulose n=6 Participants These participants will consume a fiber supplement in place of creatine monohydrate at a matched dose with muscle stretching. Cellulose: Cellulose will be used in combination with muscle stretching.
Walking Distance Baseline 6MWT Distance	375 meters Standard Deviation 84	411 meters Standard Deviation 72
Walking Distance Post-stretching 6MWT Distance	405 meters Standard Deviation 65	425 meters Standard Deviation 83

SECONDARY outcome

Timeframe: Baseline and after 4 weeks of intervention

Near-infrared spectroscopy (NIRS) will be used to measure changes in oxygen saturation (%) in the gastrocnemius muscle. Measurement will be the rate (slope) of the change in oxygen saturation (StO2) per second. Thus rate of rate in oxygenation (slope) = StO2(%)/s = Δ StO2(%)/s

Outcome measures

Outcome measures
Measure	Creatine Monohydrate n=6 Participants 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. Creatine monohydrate: Creatine monohydrate will be used in combination with muscle stretching.	Cellulose n=5 Participants These participants will consume a fiber supplement in place of creatine monohydrate at a matched dose with muscle stretching. Cellulose: Cellulose will be used in combination with muscle stretching.
Change in Percent Oxygenation/Seconds Baseline Δ StO2(%)/s	0.59 delta StO2 (%/delta time(s) Standard Deviation 0.12	0.59 delta StO2 (%/delta time(s) Standard Deviation 0.40
Change in Percent Oxygenation/Seconds Post-stretching Δ StO2(%)/s	0.64 delta StO2 (%/delta time(s) Standard Deviation 0.52	0.67 delta StO2 (%/delta time(s) Standard Deviation 0.44

Adverse Events

Creatine Monohydrate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cellulose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Judy Delp

Kansas State University

Phone: 3522269535

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place