Status:

COMPLETED

Quantitative MR Methods for Lipid Emulsions

Lead Sponsor:

University of Zurich

Conditions:

Healthy

Eligibility:

All Genders

18-50 years

Phase:

EARLY_PHASE1

Brief Summary

Quantitative MR methods will be validated for the non-invasive imaging of GI processing of lipid emulsions in 18 (12+6) healthy subjects. Validation is performed by a randomized single blind two-armed...

Detailed Description

Participants will be given two lipid emulsions with different physicochemical composition in randomized order at two separate visits. A nasogastric tube will be applied for intragastric lipid emulsion...

Eligibility Criteria

Inclusion

  • Men and women between age 18 and 50
  • BMI 18-25 kg/m²
  • Written informed consent

Exclusion

  • History of GI, cardiorespiratory (including arterial hypertension), hematologic, renal, atopic, alimentary or psychiatric disorder, panic attacks, diabetes, drug or alcohol abuse
  • Prior abdominal surgery other than uncomplicated appendectomy or hernia repair
  • Requiring medication that might alter gut function, including anticholinergics, calcium channel blockers, beta blockers, laxatives, prokinetics, proton-pump inhibitors, non-steroidal anti-inflammatory drugs
  • Presence of metallic implants, devices or metallic foreign bodies
  • Pregnancy and lactation (female participants of child bearing age will receive a pregnancy test prior to study)
  • Claustrophobia
  • Regular smoking or consumption of alcohol and drugs
  • Uncertainty about the willingness or ability of the participant to comply with the protocol requirements

Key Trial Info

Start Date :

August 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2015

Estimated Enrollment :

22 Patients enrolled

Trial Details

Trial ID

NCT02226029

Start Date

August 1 2014

End Date

March 1 2015

Last Update

April 9 2015

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Division of Gastroenterology and Hepatology, University Hopsital Zurich

Zurich, Canton of Zurich, Switzerland, 8091