The Effect of Physical Properties of Lipid Emulsions on Gastrointestinal Function
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
|Official Title:||The Effect of Physical Properties of Lipid Emulsions on Gastrointestinal Motility and Transit, Hormonal Feedback, Visceral Sensation and Satiety in Healthy Volunteers|
- The GI response to lipid emulsions with different particle sizes and sensitivities to the acidic and shear environment of the stomach in terms of: motility, neurohormonal feedback, sensation and satiety [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2011|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Behavioral: Nutritional intervention
The mechanisms by which food structure impacts on lipid digestion and the subsequent metabolic processes, including the impact on satiety and satiation, are relatively unexplored, but may have great consequences on the development of effective strategies for weight management. Data from previous studies suggest that (i) the droplet size of a fat emulsion has a distinct influence on GI function and visceral perception (ii) that the biomechanical and digestive properties of the human gut may induce micro structural changes to specifically designed lipid emulsions resulting in different patterns of lipolysis.
The study will assess the effects of triglyceride emulsion with different particle (0.6, 30 μm) sizes and sensitivities to the acidic and shear environment of the stomach on GI function and the kinetics of endocrine and satiation response.
In this study healthy participants will be studied on four occasions on four separate days in a double blind randomized design. The assessment of gastric function will be monitored by novel MRI techniques and breath tests and neurohormonal response by blood sampling.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01253005
|University Hospital Zurich, Gastroenterology and Hepatology|
|Zurich, ZH, Switzerland, 8091|
|Principal Investigator:||Michael Fried, Professor MD||University Hospital Zurich, Gastroenterology and Hepatology|