The Effect of Physical Properties of Lipid Emulsions on Gastrointestinal Function

November 13, 2012 updated by: University of Zurich

The Effect of Physical Properties of Lipid Emulsions on Gastrointestinal Motility and Transit, Hormonal Feedback, Visceral Sensation and Satiety in Healthy Volunteers

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • University Hospital Zurich, Gastroenterology and Hepatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

September 29, 2010

First Submitted That Met QC Criteria

December 2, 2010

First Posted (Estimate)

December 3, 2010

Study Record Updates

Last Update Posted (Estimate)

November 14, 2012

Last Update Submitted That Met QC Criteria

November 13, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • SNF 320030_0-0197

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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