Postprandial Lipid Metabolism in Patients With Hypertriglyceridemia and Normo-lipidemic Controls: Medium Chain Fatty Acids (MCT) in Comparison to Long-chain, Saturated Fatty Acids (SFA) and Mono-unsaturated Fatty Acids (MUFA)

September 13, 2021 updated by: Klaus Parhofer, Ludwig-Maximilians - University of Munich
Postprandial lipid metabolism will be evaluated in patients with hypertriglyceridemia and normo-lipidemic controls; different fats will be used (saturated fatty acids, mon-unsaturated fatty acids and medium chain fatty acids) for the oral fat challenge.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 81377
        • University Munich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • hypertriglyceridemia (150 mg/dl-900 mg/dl)

Exclusion Criteria:

  • Lipid lowering drugs or indication for Lipid lowering drugs
  • LDL-cholesterol > 190 mg/dl
  • Diabetes mellitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MCT
subjects start with MCT fat load
Other: MCT
patients will receive fat load with MCT
Other: SFA
patients will receive fat load with SFA
Other: MUFA
patients will receive fat load with MUFA
Experimental: SFA
subjects start with SFA fat load
Other: MCT
patients will receive fat load with MCT
Other: SFA
patients will receive fat load with SFA
Other: MUFA
patients will receive fat load with MUFA
Experimental: MUFA
subjects start with MUFA fat load
Other: MCT
patients will receive fat load with MCT
Other: SFA
patients will receive fat load with SFA
Other: MUFA
patients will receive fat load with MUFA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postprandial hypertriglyceridemia
Time Frame: 8 hours after fat meal
area under the curve following oral fat load
8 hours after fat meal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

January 31, 2021

Study Completion (Actual)

March 31, 2021

Study Registration Dates

First Submitted

February 18, 2019

First Submitted That Met QC Criteria

February 18, 2019

First Posted (Actual)

February 20, 2019

Study Record Updates

Last Update Posted (Actual)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 13, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCT-HTG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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