RCT to Compare Orlistat and Polyglucosamine for the Management of Overweight and Obesity

Randomized, Double-blind, Clinical Investigation to Compare Orlistat 60 mg and a Customized Polyglucosamine, Two Treatment Methods for the Management of Overweight and Obesity

This trial compares two treatment methods:

1. Orlistat 60 mg to be taken three times daily one capsule; indicated for weight loss in overweight adults. Important is also that it is taken along with a reduced-calorie and low-fat diet.
2. Polyglucosamine tablets to be taken two times daily two tablets, taken with the two main meals with the highest fat content, indicated for weight maintenance and weight loss.

Inclusion Criteria:

• BMI ≥ 28 kg/m² and < 45 kg/m²
• Waist circumference > 80 cm (women) > 94 cm (men)

Exclusion Criteria:

• Energy intake lower than the standard value according to Miffin St-Jeor equation
• Pregnancy or breast-feeding
• Addiction to alcohol
• Inability to fulfil the requirement of the trial protocol
• Cancer ,malignant tumour
• Hypersensitivity reactions to crustaceans or ingredient of the study medication
• Chronic diseases not under control with adequate therapy
• Diabetes