Safety Studies

7-oxo DHEA underwent a series of thorough toxicology evaluations. These studies were conducted using pharmaceutical industry protocols. They started with basic pre-clinical toxicology studies and culminated in a Phase I safety trial in humans. The majority of these studies have been published in peer review journals.

The preclinical program consisted of four toxicology evaluations, the design and results  of which can be seen in the table. These studies indicated that 7-Oxo DHEA  is not toxic and does not alter any significant body organs or processes, even at extremely large doses.

Confirmation of the lack of toxicity in our preclinical studies led to the confidence to put 7-Oxo DHEA  into an escalating dose human safety trial. This double-blind and placebo-controlled trial was conducted at the Chicago Center for Clinical Research. The results were published in Clinical Investigative Medicine 2000, and indicate that 7-Oxo DHEA  is safe for human consumption at doses up to 200mg per day. The conclusion of the principal investigator was as follows, “[7-Oxo DHEA ]…which is not converted to estrogens and androgens, was found to be safe and well-tolerated…at doses up to 200mg/d. [7-Oxo DHEA ] was found to lack any of the clinically significant hormone elevating action that has been reported with DHEA supplementation.”

Careful toxicology and safety studies are paramount to ensuring the basic premise of safety for any ingested compound, which is especially true in today’s market. However, most dietary supplements lack this level of thorough study and many lack even basic toxicology research. As many weight loss compounds come under scrutiny for safety, 7-Oxo DHEA  provides peace of mind that it can be used safely.

Pharmacokinetics – Safety Clinical Study

A complete pharmacokinetic analysis of 7-oxo DHEA was performed as part of the clinical safety study performed by Davidson. The analysis was under the direction of Ronald Sawchuk, PhD of the University of Minnesota-College of Pharmacy. Similar to DHEA, 7-oxo DHEA is rapidly sulfated to 7-oxo DHEA-sulfate in the body. An analytical method was developed for quantitation of 7-oxo DHEA-sulfate in human plasma. This was an HPLC method, which utilized calibration curves for 7-oxo DHEA-sulfate in the range of 10 to 500 ng/ml.

Trough levels were measured after each escalating dose sequence; 0, 50, 100 and 200 mg per day. Trough plasma concentrations increased proportionally to the daily dose. Mean trough levels (15.8ng/ml) after 1 week of dosing at 200 mg/day were similar to those determined after 4 weeks of dosing (16.3 ng/ml). This indicated that the ratio of the formation rate of this metabolite to its elimination clearance is constant during multiple dosing and does not accumulate.

After a twelve-hour washout period all twenty-two subjects were given a single dose of 7-oxo DHEA at 100 mg and plasma levels were obtained at 0.25, 0.50, 1.0, 2.0, 4.0, 6.0 and 12.0 hrs after the dose. The mean plasma concentrations are depicted in the chart below and demonstrate a peak plasma level of 158 ng/ml which occurred at 2.2 hours after the dose. The average elimination half-life was determined to be 2.17 hours.

Based on this data, the dosing regime of twice a day was set and remains the ideal dosing  schedule centered around steady state blood levels. Lastly, simulations of plasma concentrations of 7-oxo DHEA-3-sulfate were performed to represent the regimens employed in the dose escalation phase of the study. A one-compartment model was assumed with first order absorption and no lag phase. The results of these simulations
using this pharmacokinetic model showed that there was good agreement between the simulated and measured means of the trough plasma levels and also the plasma concentrations of a single 100mg oral dose.

This pharmacokinetic analysis is very valuable because it describes exactly how the body absorbs, metabolizes and excretes 7-oxo DHEA. It reveals that 7-oxo DHEA is rapidly absorbed and converted to its sulfate derivative, it reaches peak plasma concentrations in 2.2 hours and has a half-life of 2.17 hours. There is no accumulation with repeated dosing
and with twice daily dosing should reach a steady state plasma level in 11 hours.

Manufacturing & Quality

7-Oxo DHEA  is manufactured using GMP guidelines to exacting specifications. These specifications include a review of not only the purity and potency of each lot manufactured, but also a thorough examination of all impurities. It has been proven in many infamous and unfortunate cases, that lack of control in the manufacturing process leading to unknown impurities can have significant and serious adverse effects. Ultraburn goes to the added expense of a 100% test program prior to release of any lot.
This test program is conducted at an independent analytical laboratory and certifies 14 different quality specifications.

DSHEA Notification

Prior to marketing 7-Oxo DHEA  as a dietary supplement, it was submitted for a review of safety to the Food and Drug Administration (FDA) in the form of a New Dietary Ingredient (NDI) premarket notification. This document can be viewed at the FDA website and it received no comments or concerns from the FDA. Subsequent to this initial filing, another NDI premarket notification has been filed specific to the use of 7-Oxo DHEA  for weight loss in adults at the prescribed dosage. This notification received no comments or concerns from the FDA.

These statements have not been evaluated by the FDA. This product is not intended to treat, diagnose, cure, mitigate or prevent any disease. Consult with your doctor before starting any diet or exercise program. *Avg. weight loss 6.35 lbs in 8 weeks with same formula as Ultraburn vs 2.14 pounds with placebo. Both groups dieted and exercised.