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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)

Primary Purpose

Hypertriglyceridemia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
MCT
SFA
MUFA
Sponsored by
Ludwig-Maximilians - University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypertriglyceridemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Munich

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

MCT

SFA

MUFA

Arm Description

subjects start with MCT fat load

subjects start with SFA fat load

subjects start with MUFA fat load

Outcomes

Primary Outcome Measures

postprandial hypertriglyceridemia
area under the curve following oral fat load

Secondary Outcome Measures

Full Information

First Posted
February 18, 2019
Last Updated
September 13, 2021
Sponsor
Ludwig-Maximilians - University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT03846908
Brief Title
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)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig-Maximilians - University of Munich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MCT
Arm Type
Experimental
Arm Description
subjects start with MCT fat load
Arm Title
SFA
Arm Type
Experimental
Arm Description
subjects start with SFA fat load
Arm Title
MUFA
Arm Type
Experimental
Arm Description
subjects start with MUFA fat load
Intervention Type
Other
Intervention Name(s)
MCT
Intervention Description
patients will receive fat load with MCT
Intervention Type
Other
Intervention Name(s)
SFA
Intervention Description
patients will receive fat load with SFA
Intervention Type
Other
Intervention Name(s)
MUFA
Intervention Description
patients will receive fat load with MUFA
Primary Outcome Measure Information:
Title
postprandial hypertriglyceridemia
Description
area under the curve following oral fat load
Time Frame
8 hours after fat meal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University Munich
City
Munich
ZIP/Postal Code
81377
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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)

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