Phase I Hoodia Studies

Hoodia Flower - YotvataThe effects of the Hoodia Gordonii plant as a natural appetite suppressant are studied worldwide by scientists in their quest to find safe and healthy solutions for the problem of overweight adults and children. We will further talk about the Phase I of the Hoodia study conducted by Phytopharm PLC and its subsequent report written by Dr. V.J. Maharaj from the Council for Scientific and Industrial Research (CSIR).

Phase I – Summary

The CSIR and Phytopharm have signed an agreement for the future development and commercialization of Hoodia Gordonii as an active ingredient in a number of different ways.
The first phase of the study has the role to determine the effects and the safety of a spray dried (spraying a substance into hot air and retrieving the resultant product) extract of Hoodia on obese male and female participants. In this first phase of the study, 20 male subjects have entered and completed it. There have been no obese women subjects in the study. The male subjects’ admission criteria have referred to: healthy obese subjects with ages between 18 and 55 who have a body mass index of at least 26 and less than 45.

Objectives and Results

The objectives of the study have been to determine the following:
– The drug’s safety and tolerability of ascending oral doses of the drug called P57FP
– The effects of a single oral dose of the drug on suppression of appetite
– To collect samples from the subjects for further pharmacokinetic profiling
During the tests, the subjects have been observed, physically examined, questioned to determine the appearance of any symptoms, monitored and tested at specific times to ensure the tolerability and safety of the drug.

The 20 obese male subjects have received an ascending, single oral dose of the P57FP drug. The study involved the use of four dose levels: 10, 30, 100 and 300 mg. The results were positive at all the dose levels: they were safe and tolerated by healthy obese male subjects. The study has also shown that there have been few adverse events related to flatulence, nausea and headaches. There have not been recorded any significant changes in the participants’ vital signs, 12-lead ECG and any other laboratory evaluations or physical examination tests.

There have been pharmacological effects recorded. Even if there has been no suppression of appetite indicated by the assessments during the study, there has been recorded a decrease in the caloric content of the food eaten by the subjects for all dose levels in comparison with the placebo.

The plasma concentrations of the two chemical constituents of the drug have been below quantifiable limits. This indicates a negligible absorption of the active ingredient, P57P.
In conclusion, the active ingredient – spray dried extract of Hoodia – is considered a safe and tolerated natural appetite suppressant for the participants enrolled in the study.