Monitoring of Hepatic Fat Metabolism Using Magnetic Resonance Methods

NCT ID: NCT03680248

Last Updated: 2020-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-26

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Hepatic Fat Content

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy subjects, Fat

non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - high-fat load intervention

Group Type EXPERIMENTAL

Fat

Intervention Type DIETARY_SUPPLEMENT

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

Steatosis, Fat

non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - high-fat load intervention

Group Type EXPERIMENTAL

Fat

Intervention Type DIETARY_SUPPLEMENT

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

Healthy subjects, Fasting

non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - fasting

Group Type OTHER

Fasting

Intervention Type DIETARY_SUPPLEMENT

Subjects will fast throughout the experiment.

Steatosis, Fasting

non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - fasting

Group Type OTHER

Fasting

Intervention Type DIETARY_SUPPLEMENT

Subjects will fast throughout the experiment.

Healthy subjects, Fat+Glucose

non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - high-fat load + glucose administration

Group Type EXPERIMENTAL

Fat+Glucose

Intervention Type DIETARY_SUPPLEMENT

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.

Steatosis, Fat+Glucose

non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - high-fat load + glucose administration

Group Type EXPERIMENTAL

Fat+Glucose

Intervention Type DIETARY_SUPPLEMENT

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.

Healthy subjects, Glucose

non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - glucose administration

Group Type EXPERIMENTAL

Glucose

Intervention Type DIETARY_SUPPLEMENT

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

Steatosis, Glucose

non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - glucose administration

Group Type EXPERIMENTAL

Glucose

Intervention Type DIETARY_SUPPLEMENT

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

Healthy subjects, Fat+Fructose

non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - high-fat load + fructose administration

Group Type EXPERIMENTAL

Fat+Fructose

Intervention Type DIETARY_SUPPLEMENT

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.

Steatosis, Fat+Fructose

non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - high-fat load + fructose administration

Group Type EXPERIMENTAL

Fat+Fructose

Intervention Type DIETARY_SUPPLEMENT

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.

Healthy subjects, Fructose

non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - fructose administration

Group Type EXPERIMENTAL

Fructose

Intervention Type DIETARY_SUPPLEMENT

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

Steatosis, Fructose

non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - fructose administration

Group Type EXPERIMENTAL

Fructose

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Fat

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

Intervention Type DIETARY_SUPPLEMENT

Fasting

Subjects will fast throughout the experiment.

Intervention Type DIETARY_SUPPLEMENT

Fat+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.

Intervention Type DIETARY_SUPPLEMENT

Glucose

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

Intervention Type DIETARY_SUPPLEMENT

Fat+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.

Intervention Type DIETARY_SUPPLEMENT

Fructose

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Institute for Clinical and Experimental Medicine

OTHER_GOV

Sponsor Role lead

Responsible Party

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Jan Kovar

Head of the laboratory

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Milan Hajek, DSc

Role: PRINCIPAL_INVESTIGATOR

Institute for Clinical and Experimental Medicine

Locations

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Institute for Clinical and Experimental Medicine

Prague, , Czechia

Site Status

Countries

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Czechia

References

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Dusilova T, Kovar J, Drobny M, Sedivy P, Dezortova M, Poledne R, Zemankova K, Hajek M. Different acute effects of fructose and glucose administration on hepatic fat content. Am J Clin Nutr. 2019 Jun 1;109(6):1519-1526. doi: 10.1093/ajcn/nqy386.

Reference Type DERIVED
PMID: 31136656 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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G285

Identifier Type: -

Identifier Source: org_study_id

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