Creatine as nutritional supplementation and medicinal product

Area of Science:

• Biochemistry and Sports Science
• Pharmacology and Toxicology
• Regulatory Affairs

Background:

• Creatine monohydrate is widely used for its assumed ergogenic effects in sports.
• Its administration impacts physiological functions, potentially classifying it as a medicinal product under EU directives.
• Concerns exist regarding quality, safety, dosage, and potential contaminants in creatine supplements.

Purpose of the Study:

• To evaluate the classification of creatine monohydrate as a medicinal product.
• To review the biochemical, pharmacokinetic, and pharmacodynamic effects of creatine.
• To assess the safety, quality, and appropriate dosage of creatine supplementation.

Main Methods:

• Review of EU directives and court rulings on medicinal products.
• Analysis of biochemical mechanisms of creatine action (ATP synthesis, creatine kinase system).
• Examination of pharmacokinetic (muscle uptake) and pharmacodynamic (exercise performance) data.
• Assessment of reported side effects, contaminants, and regulatory actions (e.g., French ban).

Main Results:

• Creatine administration enhances ATP synthesis and high-intensity exercise capacity.
• Potential side effects include weight gain, insulin influence, and renal concerns.
• Industrial production can lead to contaminants like dicyandiamide and dihydrotriazines.
• Risk of BSE contamination exists if sarcosine is sourced from bovine tissues.
• Dosage recommendations vary: <3g/day for recreational users, <6g/day for athletes under supervision, >6g/day for therapeutic use.

Conclusions:

• Creatine monohydrate's physiological effects and potential risks warrant its consideration as a medicinal product.
• Strict quality control, defined contaminant limits, and appropriate medical supervision for higher doses are essential.
• Dosage should be tailored to individual needs, ranging from supplementary to therapeutic levels.