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The Effect of Physical Properties of Lipid Emulsions on Gastrointestinal Function

NCT ID: NCT01253005

Last Updated: 2012-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-11-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Healthy Controls

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Fried, Professor MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Gastroenterology and Hepatology

Locations

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University Hospital Zurich, Gastroenterology and Hepatology

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 28228504 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25833970 (View on PubMed)

Other Identifiers

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SNF 320030_0-0197

Identifier Type: -

Identifier Source: org_study_id