14-Day Repeat Dose Phase I Study – Hoodia Gordonii

The extract of Hoodia Gordonii as a natural appetite suppressant is popular for overweight people who are fighting to lose extra pounds. Phytopharm PLC has signed an agreement with the Council for Scientific and Industrial Research (CSIR) to conduct studies on the Hoodia Gordonii to determine its effects as a natural appetite suppressant. We will further describe the Phase I, placebo-controlled, 14-day repeat dose study based on the report made by Dr. V.J. Maharaj from the CSIR.

The Synopsis of the Study
The study’s goal is to test the effects of the capsules containing spray-dried extract of Hoodia Gordonii, known as P57FP, in suppressing appetite. The results of this and other studies will determine the future commercialization of Hoodia Gordonii as a natural appetite suppressant.

The study has included 16 healthy male subjects, with ages between 18 and 50 years, with a value of the body mass index (BMI) situated between 21 kg/m2 and 30 kg/m2. Eight of the subjects have received the P57FP while the remaining eight have received placebo. The treatment has lasted for 14 days. In the first 7 days, the subjects on P57FP received four capsules, an hour before breakfast. In the last 7 days, they received 2 grams of P57FP, an hour prior to breakfast and another dose of 2 grams P57FP 12 hours later.

The objectives are:

– To observe if P57FP is safe and tolerated and its effect on appetite and food intake
– To make a preliminary safety profile for the 14 days pf treatment with repeated dosing of P57FP
– To evaluate the treatment and its effects on appetite suppression and inhibition of food intake
– To obtain samples for pharmacokinetic profiling
– To determine the time course of the return of appetite

Results and Conclusions
This has been an exploratory study to determine the effects of the Hoodia Gordonii extract as a natural appetite suppressant.

The mean calorie intake between the subjects on P57FP has been slightly lower than in the case of the subjects on placebo.

The mean body weight and the mean BMI has decreased slightly in the case of the subjects on P57FP while in the other case, both increased slightly.

The mean calorie intake on the hypocaloric diet days was slightly higher for the P57FP subject compared to the other subjects.

The results showed that the P57FP dosage used in the study is safe and tolerated by the subjects.

However, there have been no notable differences between the two groups when it comes to appetite, calorie intake or body food.

The lack of effect of the P57FP as a natural appetite suppressant is due to the small sample size of this exploratory study, according to its conclusions.

1 Respond for 14-Day Repeat Dose Phase I Study – Hoodia Gordonii

  1. […] Plenty of studies have already been done into the effects of hoodia, and in fact some of them are featured on the official site so that you can directly take a look at the research and what was found through it. One study that was carried out by Phytopharm looked at how the extract would have an effect on healthy male subjects , and in this case after a fifteen day repeat dose study it was found that there were some natural appetite suppression qualities to the extract. But the researchers who conducted the study also suggested that further testing was required. The subjects were given four capsules an hour before breakfast for the first week, and then two grams an hour before breakfast followed by another two grams twelve hours later in the second week. They also found that a dosage of 1800mg was too high , and that it caused side effects such as taste perversion, paraesthesia, and hyperbilirubinaemia – so keep that in mind when you are thinking about how many of the ice cubes you should take a day. This is just one study which has been carried out to find good results, and we have to bear in mind that it was carried out on males only (no overweight participants, and none who were female), as well as the fact that there was only a very small group of participants involved. This means that there may be some doubt concerning the results. […]