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Completed

NCT Number: NCT01253005

The Effect of Physical Properties of Lipid Emulsions on Gastrointestinal Function

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

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich, Gastroenterology and Hepatology

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutritional Intervention

Behavioral

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 3, 2010
Registry last updated
Nov 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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