NCT02774486

Efficacy and Safety of IQP-AK-102 in Reducing Appetite

Open-Label Clinical Investigation to Evaluate Efficacy and Safety of IQP-AK-102 on Appetite Reduction in Healthy Over- Weight Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: InQpharm Group · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary cause of being overweight is an imbalance in calories consumed and energy expenditure. A surplus in energy intake might result in body fat deposition and thereby body weight gain. Therefore, food intake regulation is crucial to control the body weight gain. Appetite regulation plays an important role in determining the food intake, which is a complex process influenced by the individual (physiology and psychology) and environment. Satiation (process that leads to the termination of eating) and satiety (decline in hunger, increase in fullness after a meal has finished) are the precursors of appetite regulation, which may be induced by various food components such as macronutrients, water, alcohol and non-digestible polysaccharides. High viscosity and swellable/bulking food components such as dietary fibre are expected to elicit stronger satiation/satiety than the macronutrients or clear liquid. Due to its unique physicochemical properties, dietary fibre has been recognized as potential ingredient that helps to enhance the sensation of satiety in the upper gut by increasing gastric distension and delaying gastric emptying, which subsequently reduces the food intake. IQP-AK-102 comprises of a proprietary blend of dietary fibres known to promote a feeling a fullness. The objectives of this study are to evaluate the efficacy and safety of IQP-AK-102 on appetite reduction in overweight subjects during a 4-weeks interval.

Conditions

• Appetite Regulation
• Appetite Suppression
• Energy Intake

Interventions

Type	Name	Description
DEVICE	IQP-AK-102	IQP-AK-102 has been qualified as a medical device (CE certificate has been ob- tained), class IIb, according to MDD 93/42/EEC, annex IX, rule 5.

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-07-20
• Completion: 2016-07-20
• First posted: 2016-05-17
• Last updated: 2018-01-03

Locations

1 site across 1 country: Germany