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/34564441Actively Recruiting
Phase Not Applicable
Age: 18Years - 70Years
MALE
Healthy Volunteers
ID06751862
The Effect of Simple Carbohydrates on the Development of Non-alcoholic Fatty Liver Disease (FROGLOSA)
Led by Institute for Clinical and Experimental Medicine · Updated on 2024-12-30
40
Participants Needed
1
Research Sites
N/A
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 investigating how different simple sugars—glucose, fructose, and sucrose—affect the buildup of fat in the liver, particularly in males with and without obesity. The study focuses on non-alcoholic fatty liver disease (NAFLD), a common liver condition linked to obesity and metabolic issues. The goal is to understand how these sugars influence liver fat content after a high-fat meal and whether restricting fructose can reduce liver fat in affected individuals. The study has two parts. In Part A, male participants are divided into non-obese and obese groups. Each participant undergoes three full-day sessions where they consume a high-fat cream along with fruit tea sweetened with either glucose, fructose, or sucrose at intervals. Liver fat is measured before and six hours after intake using MRI and MRS scans. In Part B, male participants with moderate liver fat levels follow a fructose-free diet for seven days, replacing fructose and sucrose with glucose or starch. Liver fat and blood fat profiles are measured before and after this dietary intervention. Participants will undergo detailed assessments including MRI, MRS, blood tests measuring triglycerides, fatty acids, insulin, and glucose, as well as genetic testing for genes related to liver fat accumulation. Body composition and visceral fat are also measured. The study tracks changes in liver fat and related blood markers over time, with follow-ups lasting up to three years for some analyses. The research aims to provide new insights to improve dietary guidelines and management of NAFLD.
CONDITIONS
Brief Title
The Role of Sugars in Fat Accumulation in the Liver
Who Can Participate
Age: 18Years - 70Years
MALE
Healthy Volunteers
Eligibility Criteria
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 subjects with hepatic fat content higher than 6.2% and less than 16.5% (steatosis grade 2)
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 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 (Part A and B)
- Intolerance of MR examination (claustrophobia, metal implants, etc.) (Part B only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment, including medical history, blood tests, and MR examination
Treatment - Part A: High-fat load with sugars
Duration - Three separate 8-hour visits spaced at least 2 weeks apart, over approximately 8 weeks
Participants receive a high-fat load with fruit tea sweetened with glucose, fructose, or sucrose during three separate full-day examinations. Each examination lasts approximately 8 hours, with measurements of hepatic fat content before and after the intervention.
3 full-day visits (in-person), each including MR spectroscopy, multiple blood draws, and controlled dietary intake with no food except water and fruit tea
Treatment - Part B: Short-term fructose restriction diet
Duration - 7 days
Participants adhere to a 7-day diet eliminating fructose, supplemented with glucose and fructose-free foods. Hepatic fat content and blood samples are measured before and after the dietary intervention.
2 visits (in-person) for fasting blood draws and MR spectroscopy at the start and end of the 7-day diet, with daily dietary records kept by participants
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
MR spectroscopy as a tool for in vivo determination of steatosis in liver transplant recipients.
Milan Hájek, Monika Dezortová, Dita Wagnerová...
https://pubmed.ncbi.nlm.nih.gov/21744232Acute 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/34099584Different acute effects of fructose and glucose administration on hepatic fat content.
Tereza Dusilová, Jan Kovář, Miloslav Drobný...
https://pubmed.ncbi.nlm.nih.gov/31136656