NCT03846908

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

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

February 1, 2019

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

February 18, 2019

Last Update Submit

September 13, 2021

Conditions

Hypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

  • postprandial hypertriglyceridemia

    area under the curve following oral fat load

    8 hours after fat meal

Study Arms (3)

MCT

EXPERIMENTAL

subjects start with MCT fat load

Other: MCTOther: SFAOther: MUFA

SFA

EXPERIMENTAL

subjects start with SFA fat load

Other: MCTOther: SFAOther: MUFA

MUFA

EXPERIMENTAL

subjects start with MUFA fat load

Other: MCTOther: SFAOther: MUFA

Interventions

MCTOTHER

patients will receive fat load with MCT

MCTMUFASFA
SFAOTHER

patients will receive fat load with SFA

MCTMUFASFA
MUFAOTHER

patients will receive fat load with MUFA

MCTMUFASFA

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Munich

Munich, 81377, Germany

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Endocrinology and Metabolism

Study Record Dates

First Submitted

February 18, 2019

First Posted

February 20, 2019

Study Start

February 1, 2019

Primary Completion

January 31, 2021

Study Completion

March 31, 2021

Last Updated

September 14, 2021

Record last verified: 2021-09

Locations

DE(1)