- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03846908
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
-
-
-
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
|
patients will receive fat load with MCT
patients will receive fat load with SFA
patients will receive fat load with MUFA
|
Experimental: SFA
subjects start with SFA fat load
|
patients will receive fat load with MCT
patients will receive fat load with SFA
patients will receive fat load with MUFA
|
Experimental: MUFA
subjects start with MUFA fat load
|
patients will receive fat load with MCT
patients will receive fat load with SFA
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.
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.
Clinical Trials on Hypertriglyceridemia
-
Arrowhead PharmaceuticalsNot yet recruitingSevere Hypertriglyceridemia
-
89bio, Inc.RecruitingSevere HypertriglyceridemiaUnited States, Bulgaria, Canada, Latvia, Spain, Austria, Belgium, Czechia, Georgia, Hungary, Poland, Puerto Rico, Argentina, Chile, France, Germany, United Kingdom
-
Ionis Pharmaceuticals, Inc.RecruitingSevere HypertriglyceridemiaUnited States, Germany, Israel, Spain, Netherlands, Australia, Hungary, Sweden, Denmark, Canada, France, Italy, Turkey, Finland, Bulgaria, Czechia, New Zealand, Norway, Poland, Portugal, Slovakia, South Africa, United Kingdom
-
Sancilio and Company, Inc.WithdrawnSevere Hypertriglyceridemia
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Arrowhead PharmaceuticalsCompletedSevere HypertriglyceridemiaUnited States, Netherlands, Australia, Canada, New Zealand, Poland, Hungary, Germany
-
AstraZenecaCompletedSevere HypertriglyceridemiaUnited States, Hungary, India, Russian Federation, Denmark, Ukraine, Netherlands
-
AstraZenecaRadiant ResearchCompletedSevere HypertriglyceridemiaUnited States
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Trygg Pharma, Inc.UnknownSevere HypertriglyceridemiaUnited States
-
National Taiwan University HospitalUnknownHypertriglyceridemia During PregnancyTaiwan
-
DongKoo Bio & PharmaUnknownHyperlipidemia, HypertriglyceridemiaKorea, Republic of
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-
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-
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-
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Medical University of WarsawCompleted
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Université de SherbrookeCompleted
-
Klinik ValensRecruitingMultiple Sclerosis, Chronic Progressive | High-Intensity Interval Training | Motor SymptomsSwitzerland
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University of LiverpoolVitaflo International, Ltd; Walton Centre NHS Foundation TrustCompletedGlioblastoma | Glioblastoma Multiforme | Glioblastoma, AdultUnited Kingdom
-
McGill University Health Centre/Research Institute...CompletedPhysical Activity | Colorectal CancerCanada