PREE® Clinical Trial Results
PREE® has been evaluated in a clinical trial designed to define its clinical efficacy and safety. From December 2007 through February 2008, thirty participants were evaluated at four clinical sites located at physician-managed medical weight loss clinics. Each enrollee signed an informed consent and was provided with ninety 750mg capsules of PREE®. Participants were instructed to take PREE® as directed and return weekly for weigh-ins, consultation and to answer study questionnaires. Information was collected weekly for four weeks from each person regarding: a) certain personal information; b) diet and eating habits and behaviors; c) PREE® utilization; d) PREE® effectiveness; e) hunger status; f) meal portion sizes, and g) any associated side effects or adverse events. The findings are summarized below*:
- Participant Statistics:
- Average Age: 49
- Average Beginning: BMI - 30.5; Weight - 183 lbs; Height - 65 in
- Average Ending: BMI - 29.3; Weight - 175 lbs; Height - 65 in
- Responders: 94.1%
- Average 4-week Weight Loss: 7.6 lbs (4.2% of Body Mass)
- Average Number of Capsules Taken per Day: 2.1
- Average Reduction in Meal Portion Size: 34.3%
- Average Rating of Hunger Control Effectiveness: 86.7%
- Average Time to "feel" Fullness Effect: 33 minutes
- Average Duration of "Fullness" Effect: 2.5 hours
- Total Doses Administered: >2,000
- Total Incidence of Side-effects: 3.6%; Adverse Events: None
Additional information was also analyzed as below*:
In this study, participants were asked to rate their responses from PREE's effects at each of breakfast, lunch and dinner. PREE® generated a sensation of fullness or early satiety 94.1% of the time. In 5.9% of meals, patients described that "No Effect" was noted.
One of the most important findings of this or any clinical study is the determination of side effects and the recording of any study-related adverse events. Graph 2 shows the total incidence of occurrence of all study related side effects equaled 3.6%
Of importance, no adverse events were reported during the study. Slight burping for a few minutes as the capsules dissolved (within 10 minutes of ingestion) was the most common side effect reported. Occasionally, these burps were accompanied with a mild taste that lasted a few minutes.
The ability for PREE® to assist participants in losing weight was also measured. As can be seen in Graph 3 below; participants lost an average of 1.9 pounds per week, with an average weight loss of 7.6 pounds over the 4-week study.
Most weight management experts agree that if weight is lost too rapidly it will generally not be sustainable. Therefore, most recommend that people lose weight more slowly - generally in the range of 1 to 2 pounds per week so that the weight that comes off can stay off. PREE® is designed to help people lose weight sensibly and progressively without feeling hungry or deprived in the process.
The makers of PREE® are very encouraged by these results. None of the investigators or any patients has any relationship with or financial interests in the Company or the PREE® technology. Both the independent investigators and the study participants volunteered to undertake the study without payments or promises of any kind.
The findings of this study, while promising, are by no means conclusive. Larger controlled trials are indicated. Wellosophy is encouraged and intends to pursue larger studies in the future to learn more about the role of PREE® as a novel hunger management tool.*
* These statements have not been evaluated by the US Food and Drug Administration.
This product is not intended to diagnose, treat, cure or prevent any disease.