Official Title: “Supplement Contamination: Detection of Nandrolone Metabolites in Urine After Administration of Small Doses of a Nandrolone Precursor”

There is compelling evidence that some dietary supplements consumed by the general population are manufactured and stored under conditions that lead to contamination of the end product with small amounts of extraneous materials. In most cases, this is harmless, but for athletes liable to drug testing as a consequence of their participation in sport, the potential consequences of even trivial amounts of a prohibited substance may be catastrophic. Quality control procedures for pharmaceutical products normally specify the absence of contaminants at a level of more than 0.1%, ie 1mg/g. However, in the case of an anabolic steroid such as nandrolone, the amount that will cause a positive test has been estimated to be about 1-3µg (Geyer et al, 2004). In the case of a supplement that is taken in high doses (20-30 g/d), such as for example creatine, this means that a contamination level of something closer to 0.00001% (ie 1µg/g) may cause a positive test. This work have been supported by recent findings from our laboratory (Judkins et al, 2006). These data demonstrate that as little as 10μg of 19-noradrostenedione (19-NorAD) added to a creatine supplement resulted in a positive doping test in all volunteers testing. This is one thousand times less that the purity level specified for pharmaceutical agents and at this level, these contaminants are without any pharmacological action.

Proposals are under development to regulate the sale of dietary supplements for use by athletes to avoid accidental doping positives as a result of ingestion of contaminated supplements. This requires a knowledge of the amounts of contaminant that is likely to cause problems. The aim of the present study was to examine the urinary excretion pattern of nandrolone metabolites following 1µg, 2.5µg and 5µg doses of 19-norandrostendione in both male and female subjects. The quantity of 19-norandrostenedione administered in this study is representative of the amount previously reported as an undeclared contaminant in some dietary supplements. Given the speculation surrounding positive doping cases being attributed to ingestion of sports supplements contaminated with pro-hormones, this presents an important consideration for both athletes and doping agencies, as well as supplement manufacturers.

Study Type: Interventional

Study Design: Basic Science, Randomized, Single Blind (Subject), Crossover Assignment

Study Primary Completion Date: September 2006

Intervention(s) in this Clinical Trial

• Dietary Supplement: 19-norandrostendione
  • Volunteers recieved 500mL of water containing 5g of creatine monohydrate and either 1.0μg, 2.5μg or 5.0μg of 19-norandrostendione in a single-blind crossover manner. The amount of 19-norandrostendione administered was trivial, and far less than the amounts shown to be present in many popular dietary supplements. The recommended dosage according to the distributors is 100 mg 2-3 times daily, so the administered daily dose was not more than 0.05% of the recommended dose. This dose has no measurable physiological or pharmacological effects.

Primary Measures

• Urinary 19-norandrosterone (19-NA) and 19-noretiocholanolone (19-NE) concentrations
  • Time Frame: All urine passed for 24h following supplement ingestion
    Safety Issue?: No

Inclusion Criteria:

• Healthy male and female volunteers aged between 18 - 35 years of age

Exclusion Criteria:

• Any potential participant competing in sport at a level where there is even a remote possibility of being called for a drugs test was excluded

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 35 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Loughborough University

Overall Clinical Trial Officials and Contacts

Ronald Maughan, PhD Principal Investigator Loughborough University  

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00682123

Study ID Number: R05-P39

ClinicalTrials.gov Identifier: NCT00682123

Health Authority: United Kingdom: Research Ethics Committee