Monitoring of Hepatic Fat Metabolism Using Magnetic Resonance Methods

NCT03680248 | Completed

• 1 other identifier: G285
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Fat Content

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Hepatic fat content

  Change in hepatic fat content as determined by proton magnetic resonance spectroscopy (%) between 0 and 6 hours

  Before time 0 hour, 3 hours, 6 hours

Secondary Outcomes (5)

• TG

  before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours

• NEFA

  before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours

• Glucose

  before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours

• Insulin

  before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours

• Glucagon

  before 0, 0.5, 1, 2, 2.5, 3, 4, 4.5, 5, and 6 hours

Study Arms (12)

Healthy subjects, Fat

EXPERIMENTAL

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

Dietary Supplement: Fat

Steatosis, Fat

EXPERIMENTAL

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

Dietary Supplement: Fat

Healthy subjects, Fasting

OTHER

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

Dietary Supplement: Fasting

Steatosis, Fasting

OTHER

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

Dietary Supplement: Fasting

Healthy subjects, Fat+Glucose

EXPERIMENTAL

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

Dietary Supplement: Fat+Glucose

Steatosis, Fat+Glucose

EXPERIMENTAL

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

Dietary Supplement: Fat+Glucose

Healthy subjects, Glucose

EXPERIMENTAL

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

Dietary Supplement: Glucose

Steatosis, Glucose

EXPERIMENTAL

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

Dietary Supplement: Glucose

Healthy subjects, Fat+Fructose

EXPERIMENTAL

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

Dietary Supplement: Fat+Fructose

Steatosis, Fat+Fructose

EXPERIMENTAL

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

Dietary Supplement: Fat+Fructose

Healthy subjects, Fructose

EXPERIMENTAL

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

Dietary Supplement: Fructose

Steatosis, Fructose

EXPERIMENTAL

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

Dietary Supplement: Fructose

Interventions

Fat DIETARY_SUPPLEMENT

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

Healthy subjects, Fat; Steatosis, Fat

Fasting DIETARY_SUPPLEMENT

Subjects will fast throughout the experiment.

Healthy subjects, Fasting; Steatosis, Fasting

Fat+Glucose 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, Fat+Glucose; Steatosis, Fat+Glucose

Glucose DIETARY_SUPPLEMENT

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

Healthy subjects, Glucose; Steatosis, Glucose

Fat+Fructose 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, Fat+Fructose; Steatosis, Fat+Fructose

Fructose DIETARY_SUPPLEMENT

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

Healthy subjects, Fructose; Steatosis, Fructose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead

Study Sites (1)

Institute for Clinical and Experimental Medicine

Prague, 14021, Czechia

Location

Related Publications (1)

• 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.

  PMID: 31136656 DERIVED

MeSH Terms

Conditions

Insulin Resistance

Interventions

CD36 Antigens; Angptl4 protein, mouse; Glucose; Fructose

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Platelet Membrane Glycoproteins; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Fatty Acid Transport Proteins; Membrane Transport Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Receptors, Cell Surface; Receptors, Immunologic; Scavenger Receptors, Class B; Receptors, Scavenger; Receptors, LDL; Receptors, Lipoprotein; Hexoses; Monosaccharides; Sugars; Ketoses

Study Officials

• Milan Hajek, DSc

  Institute for Clinical and Experimental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the laboratory

Model Details: 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

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 21, 2018
• Study Start: April 26, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)