Effect of Creatine on Serum and Urine Creatinine

Study Overview
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Brief Summary
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Background: Creatinine (Crn) concentration is used to assess renal function via calculation of GFR (Glomerular Filtration Rate). By RIFLE (Risk, Injury, Failure, Loss, End Stage Kidney Disease) criteria, acute kidney injury (AKI) and acute renal failure (ARF) are defined by a two-fold and three-fold increase in serum Crn, respectively. Crn is a breakdown product of proteins and circulating creatine, and it is generally a benign product present in serum. Creatine is a nutritional supplement that has been available since 1993, and it is widely used among athletes today. Methods: In an IRB approved, blinded crossover trial, 25 human volunteers ingested 2 creatine supplements to determine any associated statistically significant increase in serum Crn and clinically significant increase in serum Crn to a degree associated with AKI or ARF. Urine samples were also collected to examine excretion patterns after an ingested sample. Participants ingested 10 gm of creatine ethyl ester (CEE) or creatine monohydrate (CrM) and had serum Crn assayed at 0, 1, 2, 3, 4, 5 and 24 hours. Urinary Crn levels were assayed at 0, 1.5, 3, 5 and 24 hours. Exclusion factors were any history of renal disease or use of creatine within the last month. Statistical analysis was performed by Wilcoxon Matched-Pair Signed Ranks Test and descriptive summary statistics were performed.

Official Title
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Effect of Creatine Monohydrate and Creatine Ethyl Ester on Serum and Urinary Creatinine

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Dietary Supplement: Creatine Monohydrate
* Dietary Supplement: Creatine Ethyl Ester


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 Human Exclusion Criteria: Use of any form of creatine within 4 weeks prior to participation in study. Pregnancy History of elevated creatinine or renal insufficiency History of PKU

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Creatine Monohydrate<br>Each of the 25 subjects took Creatine Monohydrate. | Dietary Supplement: Creatine Monohydrate<br>* Each subject ingested 10 grams of commercially available creatine monohydrate orally. This was equivalent to two teaspoons according to the manufacturer's recommendations. The creatine was then solubilized in 8 oz. of water and 2 tablespoons of Tang brand orange flavored drink mix.<br>* Other names: Tang brand Orange Drink, manufactured by Kraft Foods;|
| Active Comparator: Creatine Ethyl Ester<br>Each of the 25 subjects took Creatine Ethyl Ester. | Dietary Supplement: Creatine Ethyl Ester<br>* Each subject ingested 10 grams of creatine ethyl ester orally. This was equivalent to 14.25 pills according to the manufacturer's ingredient description. The pill capsules were ground into a powder, which was added to 8 oz of water along with 2 tablespoons of Tang brand orange drink.<br>* Other names: Tang brand Orange Drink, manufactured by Kraft Foods;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Creatinine | Participants ingested 10 grams of creatine monohydrate or creatine ester and had serum creatinine measured at 0, 1, 2, 3, 4, 5, and 24 hours. | 24 Hours | 
| Urine Creatinine | Participants ingested 10 grams of creatine monohydrate or creatine ethyl ester and had urinary creatinine levels measured at 0, 1.5, 3, 5, and 24 hours. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal, Creatine, Creatinine, Serum Creatinine, Urine Creatinine, Creatine Monohydrate, Creatine Ethyl Ester, Acute Kidney Injury, Kidney