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Monitoring of Hepatic Fat Metabolism Using Magnetic Resonance Methods

Monitoring of Hepatic Fat Metabolism Using Magnetic Resonance Methods

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03680248
Enrollment
18
Registered
2018-09-21
Start date
2016-04-26
Completion date
2019-12-31
Last updated
2020-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Fat Content

Keywords

hepatic fat content, dietary fat, glucose, fructose, non-esterified fatty acid, triglyceride, insulin, postprandial period

Brief summary

The first primary research objective of the study is to determine whether high-fat load (150 g of fat) induces increase in hepatic fat content (HFC) three and six hours after meal in insulin-sensitive subjects with normal HFC (\<5% of fat) and in non-diabetic subjects with an increased HFC (\>5% of fat). Furthermore, the other objective of the study is to determine whether the response of HFC to a high-fat load is affected by coadministration of glucose or fructose.

Detailed description

The epidemic of non-alcoholic fatty liver disease (NAFLD) is becoming a major challenge faced by health system worldwide. The hepatic fat comes from the major sources - non-esterified fatty acids (NEFA) released from adipose tissue, dietary fat and de novo lipogenesis. Fat accumulation in the liver then occurs when triglycerides (TG) that are formed are not rapidly enough oxidized or secreted from the liver in very low density lipoproteins (VLDL). It can be hypothesized that the capacity of the liver to eliminate TG can be overcome after high load of dietary fat. High-fat load should induce an immediate accumulation of hepatic fat that could be detected using 1H magnetic resonance spectroscopy (1H-MRS). The accumulation of liver fat can be also affected by coadministration of simple carbohydrates - glucose and fructose. The administration of these carbohydrates can have a pronounced impact on the availability of particular sources of hepatic fat.

Interventions

DIETARY_SUPPLEMENTFat

Subjects will consume dairy cream (150 g of fat) at time 0 hours.

DIETARY_SUPPLEMENTFasting

Subjects will fast throughout the experiment.

DIETARY_SUPPLEMENTFat+Glucose

Subjects will consume dairy cream (150 g of fat) at time 0 hours. At the same time and 2 and 4 hours later they will drink herbal tea containing 50 g of glucose.

DIETARY_SUPPLEMENTGlucose

Subjects will drink herbal tea containing 50 g of glucose at times 0, 2 and 4 hours.

DIETARY_SUPPLEMENTFat+Fructose

Subjects will consume dairy cream (150 g of fat) at time 0 hours. At the same time and 2 and 4 hours later they will drink herbal tea containing 50 g of fructose.

DIETARY_SUPPLEMENTFructose

Subjects will drink herbal tea containing 50 g of fructose at times 0, 2 and 4 hours.

Sponsors

Institute for Clinical and Experimental Medicine
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

10 non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) and 10 non-obese non-diabetic subjects with increased hepatic fat content (more than 5% of hepatic fat) will undergo series of six experiments - changes of liver fat content will be measured at time 0, 3 and 6 hours after specific dietary interventions

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* normal response to oral glucose tolerance test * normal glycated hemoglobin * normal aspartate aminotransferase (AST) * normal alanine aminotransferase (ALT)

Exclusion criteria

* BMI \> 30 kg/m2 * use of pharmacological agents affecting insulin sensitivity * use of pharmacological agents affecting lipid metabolism * inability to undergo 1H-MRS examination

Design outcomes

Primary

MeasureTime frameDescription
Hepatic fat contentBefore time 0 hour, 3 hours, 6 hoursChange in hepatic fat content as determined by proton magnetic resonance spectroscopy (%) between 0 and 6 hours

Secondary

MeasureTime frameDescription
TGbefore 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hoursPlasma triglyceride concentration
NEFAbefore 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hoursPlasma non-esterified fatty-acid concentration
Glucosebefore 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hoursPlasma glucose concentration
Insulinbefore 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hoursPlasma insulin concentration
Glucagonbefore 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hoursPlasma glucagon concentration

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026