The Effect of Physical Properties of Lipid Emulsions on Gastrointestinal Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01253005
First received: September 29, 2010
Last updated: November 13, 2012
Last verified: November 2012
  Purpose

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. 12 healthy participants will be studied on four occasions on four separate days in a double blind randomized design


Condition Intervention
Healthy Controls
Behavioral: Nutritional intervention

Study Type: Interventional
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

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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 ]

Enrollment: 18
Study Start Date: January 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Body mass index (BMI): 18.5-24.9 kg/m2,
  • Able to communicate well with the investigators
  • Provide written consent

Exclusion criteria:

General exclusion criteria:

  • Psychiatric (DSM IV) disorders limiting the ability to comply with study requirements
  • Epilepsy
  • Presence of metallic implants, devices or metallic foreign bodies
  • Use of medications influencing upper GI motility within one week of the study (i.e. calcium channel blockers, prokinetic drugs, macrolide antibiotics)
  • Evidence of current drug or alcohol abuse
  • Previous history of gastrointestinal disease or surgery of the upper GI tract except appendicectomy or hernia repair
  • Pregnancy and lactation period
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01253005

Locations
Switzerland
University Hospital Zurich, Gastroenterology and Hepatology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Michael Fried, Professor MD University Hospital Zurich, Gastroenterology and Hepatology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01253005     History of Changes
Other Study ID Numbers: SNF 320030_0-0197
Study First Received: September 29, 2010
Last Updated: November 13, 2012
Health Authority: Switzerland: Swissmedic

ClinicalTrials.gov processed this record on September 18, 2014