NCT02865486

Brief Summary

In this randomized, double blind, unbalanced three way crossover trial, four lipid emulsions will be assessed on three study days. The lipid emulsions (LEs) have been engineered so that they differ in terms of acid stability, lipid droplet size and fat redispersibility. The investigators hypothesize that the gastric emptying of fat will differ between the lipid emulsions. An optional study day (visit 5) will be used to assess the degree of lipolysis in Lipid emulsion 5 (LE5) and Lipid emulsion 6 (LE6). This study day is a randomized, single blinded study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 14, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 5, 2016

Status Verified

October 1, 2016

Enrollment Period

7 months

First QC Date

April 14, 2016

Last Update Submit

October 4, 2016

Conditions

Healthy

Keywords

Gastric emptyingMRIlipid emulsionsbreath testGI peptide hormones

Outcome Measures

Primary Outcomes (1)

  • The rate of gastric fat volume emptying [ml/h]

    up to 210 min

Secondary Outcomes (12)

  • The gastric content emptying time constant [min]

    up to 210 min

  • Area over baseline (AOB), maximum amplitude, time to maximum plasma concentration of CCK [pmol/L].

    up to 300 min

  • Half emptying time from 13CO2 breath test (BT_t50) [min]

    up to 300 min

  • Half emptying time of MRI fat volume (MRI_t50) [min]

    up to 210 min

  • Concordance correlation of MRI fat volume MRI_t50 and breath test BT_t50 [:]

    up to 300 min

  • +7 more secondary outcomes

Study Arms (3)

Lipid emulsion: visit 2

EXPERIMENTAL

One of four randomly assigned lipid emulsions

Dietary Supplement: Lipid emulsion

Lipid emulsion: visit 3

EXPERIMENTAL

One of four randomly assigned lipid emulsions

Dietary Supplement: Lipid emulsion

Lipid emulsion: visit 4

EXPERIMENTAL

One of four randomly assigned lipid emulsions

Dietary Supplement: Lipid emulsion

Interventions

Lipid emulsionDIETARY_SUPPLEMENT

1 of 4 isovolumetric (200 ml) and isocaloric (380 kcal) lipid emulsions with different acid and shear stability will be ingested on visit 2.

Lipid emulsion: visit 2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 18-25 kg/m²
  • Written informed consent

You may not qualify if:

  • Donated blood within the last 3 months
  • History of GI, cardiorespiratory (including arterial
  • hypertension), hematologic, renal, atopic, alimentary or psychiatric disorder, panic attacks, diabetes
  • Prior abdominal surgery other than uncomplicated appendectomy or hernia repair
  • Requiring medication that might alter gut function, including calcium channel blockers, prokinetics, macrolide antibiotics
  • 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
  • A history of drug or alcohol abuse
  • A history of food allergies or intolerances
  • Uncertainty about the willingness or ability of the participant to comply with the protocol requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Gastroenterology and Hepatology, University Hopsital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Interventions

Fat Emulsions, Intravenous

Intervention Hierarchy (Ancestors)

EmulsionsColloidsDosage FormsPharmaceutical PreparationsParenteral Nutrition SolutionsPharmaceutical SolutionsSolutionsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Andreas Steingötter, PhD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 14, 2016

First Posted

August 12, 2016

Study Start

March 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 5, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)