The Effect of Physical Properties of Lipid Emulsions on Gastrointestinal Function
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|ClinicalTrials.gov Identifier: NCT01253005|
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : November 14, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy Controls||Behavioral: Nutritional intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effect of Physical Properties of Lipid Emulsions on Gastrointestinal Motility and Transit, Hormonal Feedback, Visceral Sensation and Satiety in Healthy Volunteers|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
- Behavioral: Nutritional intervention
This study will investigate the effects of particle size of different triglyceride emulsions as well as the dynamics of intragastric structure formation and breakdown of the emulsions on GI function, the kinetics of the endocrine and the satiation response 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01253005
|University Hospital Zurich, Gastroenterology and Hepatology|
|Zurich, ZH, Switzerland, 8091|
|Principal Investigator:||Michael Fried, Professor MD||University Hospital Zurich, Gastroenterology and Hepatology|