Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
MALE
Healthy Volunteers
ID06751862

The Effect of Glucose, Fructose, and Sucrose on Liver Fat in Non-Alcoholic Fatty Liver Disease A Study of Sugar Impact and Fructose Restriction in Men with Fatty Liver

Led by Institute for Clinical and Experimental Medicine · Updated on 2024-12-30

40

Participants Needed

1

Research Sites

140 weeks

Total Duration

On this page

Sponsors

I

Institute for Clinical and Experimental Medicine

Lead Sponsor

C

Czech Health Research Council

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how different simple sugars affect fat buildup in the liver, focusing on non-alcoholic fatty liver disease (NAFLD) in male volunteers aged 18 to 70, including both non-obese and obese individuals. The study explores how glucose, fructose, and sucrose influence liver fat after a high-fat meal and investigates whether removing fructose from the diet for a week can reduce liver fat in people with fatty liver disease. This research aims to clarify the role of these sugars in liver fat accumulation and improve dietary guidelines for NAFLD management. The study has two parts. In Part A, participants receive a high-fat load (150 g of fat) combined with either glucose, fructose, or sucrose in fruit tea, administered three times over six hours. Liver fat content is measured before and after each 8-hour session using MRI and magnetic resonance spectroscopy (MRS). Part B involves a seven-day diet eliminating fructose, replaced by starch or glucose, for participants with moderate fatty liver. Liver fat and blood markers are measured before and after this dietary intervention. Participants undergo detailed assessments including MRI/MRS scans to measure liver fat and visceral fat, blood tests to monitor triglycerides, fatty acids, insulin, and glucose, and genetic testing related to liver fat accumulation. They keep dietary records during the fructose restriction phase. The study includes several visits over about eight weeks for repeated measurements in Part A and a seven-day intervention in Part B, with ongoing analysis and follow-up planned over multiple years.

CONDITIONS

Official Title

The Role of Sugars in Fat Accumulation in the Liver

Who Can Participate

Age: 18Years - 70Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male volunteers aged 18 to 70 years
  • For Part A: 15 non-obese subjects with BMI less than 30 kg/m2 and 15 obese subjects with BMI 30 kg/m2 or higher
  • For Part B: Male volunteers with hepatic fat content between 6.2% and 16.5% (steatosis grade 2)
Not Eligible

You will not qualify if you...

  • Diabetes mellitus (fasting glucose above 7 mmol/l, 2-hour glucose after oral glucose tolerance test above 11.1 mmol/l, or receiving antidiabetic treatment)
  • Serious illnesses such as cardiovascular disease or cancer
  • Alcohol consumption of 30 grams or more per day
  • Fructose intolerance (Part A only)
  • Use of drugs affecting lipid metabolism
  • Intolerance of magnetic resonance examination (claustrophobia, metal implants, etc., Part B only)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Institute for Clinical and Experimental Medicine

Prague, Czech Republic, Czechia, 14021

Actively Recruiting

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Research Team

J

Jan Kovář, PhD

D

Dita Pajuelo, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

3

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Published Research Related To This Trial

Lipid Profile and Hepatic Fat Content Measured by 1H MR Spectroscopy in Patients before and after Liver Transplantation.

Martin Burian, Milan Hajek, Petr Sedivy...

https://pubmed.ncbi.nlm.nih.gov/34564441

Acute responses of hepatic fat content to consuming fat, glucose and fructose alone and in combination in non-obese non-diabetic individuals with non-alcoholic fatty liver disease.

J Kovar, T Dusilova, P Sedivy...

https://pubmed.ncbi.nlm.nih.gov/34099584