The Effect of Physical Properties of Lipid Emulsions on Gastrointestinal Function

NCT01253005 | Completed

• 1 other identifier: SNF 320030_0-0197
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Controls

Outcome Measures

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

  2 years

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Gastroenterology and Hepatology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (2)

• Steingoetter A, Buetikofer S, Curcic J, Menne D, Rehfeld JF, Fried M, Schwizer W, Wooster TJ. The Dynamics of Gastric Emptying and Self-Reported Feelings of Satiation Are Better Predictors Than Gastrointestinal Hormones of the Effects of Lipid Emulsion Structure on Fat Digestion in Healthy Adults-A Bayesian Inference Approach. J Nutr. 2017 Apr;147(4):706-714. doi: 10.3945/jn.116.237800. Epub 2017 Feb 22.

  PMID: 28228504 DERIVED

• Steingoetter A, Radovic T, Buetikofer S, Curcic J, Menne D, Fried M, Schwizer W, Wooster TJ. Imaging gastric structuring of lipid emulsions and its effect on gastrointestinal function: a randomized trial in healthy subjects. Am J Clin Nutr. 2015 Apr;101(4):714-24. doi: 10.3945/ajcn.114.100263. Epub 2015 Feb 25.

  PMID: 25833970 DERIVED

Study Officials

• Michael Fried, Professor MD

  University Hospital Zurich, Gastroenterology and Hepatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: December 3, 2010
• Study Start: January 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 14, 2012

Record last verified: 2012-11

Locations

CH (1)