15-Day Repeat Dose Study – Hoodia Gordonii

Hoodia Gordonii as a natural appetite suppressant is the subject of many clinical studies. The plant is famous because it helps to lower your appetite; it reduces the cravings for sweets and is effective in fighting obesity. The Council for Scientific and Industrial Research (CSIR) has signed an agreement with Phytopharm PLC to study the effects of the plant in reducing the appetite for food and for further commercialization as an active ingredient in a number of different ways.

Worldwide, the Hoodia Gordonii is the number one natural appetite suppressant. This is because it is considered to have the ability to trick your brain into believing that you have already eaten.

The 15-Day Repeat Dose Study
The study will determine the effects of the concentrated spray-dried extract, known as PYM50027, on the subjects. The study is conducted on 60 healthy male subjects, with ages between 18 and 45 years, who have a body mass index (BMI) between 21 kg/m2 and 28 kg/m2 and a body fat content (BFC) < 25% or BMI between 28 kg/m2 and 36 kg/m2 and BFC > 25%:

– 23 subjects are included in the single-dose escalation stage
– 18 subjects are included in the 5-day repeat dose stage
– 19 subjects are included in the 15-day repeat dose stage

The study will determine if the PYM50027 is effective as a natural appetite suppressant.
The objectives are:

– To determine if the PYM50027 is safe and tolerable and the pharmacokinetics of single doses in subjects with a BMI of 21 – 28 kg/m2 and BFC- To determine if the PYM50027 is safe and tolerable and the pharmacokinetics of repeat doses in subjects with a BMI of 28 – 36 kg/m2 and BFC>25%
– To determine the effects of a 15-days repeat dosing of PYM50027 on calorie intake in subjects with a BMI of 28 – 36 kg/m2 and BFC>25%

Results Summary
This is an exploratory study to determine the effects of the Hoodia Gordonii extract as a natural appetite suppressant.

The use of PYM50027 on a short term has an anorectic effect. The 15-day treatment caused a noticeable reduction in calorie intake. However, there have been side effects recorded: paraesthesia, the perversion of taste and isolated reversible hyperbilirubinaemia. The dosing regimen of 1800 mg is not suitable for clinical investigation.

The effect of PYM50027 on the caloric intake suggest that further testing of either a lower dose or associated products should be conducted.

As a final conclusion, the PYM50027 is considered effective as a natural appetite suppressant, but further testing is required.