Double-blind Placebo-controlled Hoodia Study

Everybody is searching for new and healthy ways to lose weight naturally. The effects of the Hoodia Gordonii plant as a natural appetite suppressant have been studied by nutritionists worldwide to find a useful tool in the fight against obesity. One of these studies has been conducted by a British company, Phytopharm in collaboration with the Council for Scientific and Industrial Research (CSIR).

This phase of the study has the role to investigate the safety and tolerability of male subjects to a spray dried extract of the plant formulated into capsules. The pharmacokinetics and pharmacodynamics of the P57FP, as the pills are called, will also be studied. The P57FP is considered a natural appetite suppressant.

Objectives and Methods
The study has been made on 32 healthy male subjects with ages between 18 and 55 years, who have a body mass index between 21 kg/m2 and 28 kg/m2. The subjects have received a hypocaloric diet during the study. The duration of the study on each subject has been of approximately 3 weeks.
The objectives are:
- To verify if the capsules are safe and tolerated by the subjects
- To see the effects of a single dose on suppressing the appetite of the subjects
- To see its effects of a single dose on the subjects’ mood, satiety and satiation
- To collect samples for pharmacokinetic profiling of a single dose of P75FP in oral administration
The evaluation criteria have included:
- The recording of vital signs and adverse events, physical exams, electrocardiograms and routine lab evaluations to determine the safety and tolerability of the P57FP natural appetite suppressant
- For the pharmacodynamics evaluation, specially designed questionnaires were used for the assessment of the subjects’ satiety and mood
- Plasma concentrations of the active constituents of P57FP have been analyzed for pharmacokinetics

Conclusions of the Study Regarding the P57FP Natural Appetite Suppressant
The oral administration of 500 mg, 1000 mg, 2000 mg and 4000 mg doses of the capsules containing spray dried extract of Hoodia Gordonii is considered safe and tolerated by healthy male subjects.

There have been no clear results concerning the effect of P57FP on hunger, satiety and mood, independent of the dose. However, the study has indicated that higher doses have a delayed effect on appetite.

Results have also suggested that the subjects who have received the highest dose have felt less hungry, more full and found their hunger more satisfied than before taking P57FP.
This phase of the study has shown that the P57FP should be further evaluated to determine its role as a natural appetite suppressant.