NCT01233349

Safety and Efficacy of Litramine in Overweight and Obese Subjects

Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate Safety and Efficacy of LitramineTM in Reducing Body Weight in Overweight and Obese Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: InQpharm Group · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Preparations that bind to nutritional fat and inhibit its absorption could be decisively meaningful for the regulation of bodyweight or obesity. Further, it is known that soluble fibres gel and swell in the stomach and thereby induce a feeling of satiety or fullness after eating. Such effects are supposed to facilitate adherence to energy-restricted diets. The medical device to be investigated contains a patented formula of fibre complex having a high ability to bind to dietary fat. Therefore, the rationale for this study is to confirm that Litramine's proven fat binding capacity to increase fat excretion and modulate the feeling of satiety will translate into measurable reduction in body weight. A double blind, randomized, placebocontrolled design has been chosen to assess the efficacy and safety of Litramine in overweight and obese subjects on a energy-restricted diet.

Conditions

• Overweight
• Obesity
• Weight Loss

Interventions

Type	Name	Description
DEVICE	Litramine	2 tablets 3 times daily (oral consumption, 30 minutes after meal)
DEVICE	Placebo	2 tablets 3 times daily (oral consumption, 30 minutes after meal)

Timeline

• Start date: 2010-07-01
• Primary completion: 2010-12-01
• Completion: 2011-01-01
• First posted: 2010-11-03
• Last updated: 2011-10-13

Locations

1 site across 1 country: Germany