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NCT06751862Recruiting

The Role of Sugars in Fat Accumulation in the Liver

The Effect of Simple Carbohydrates on the Development of Non-alcoholic Fatty Liver Disease (FROGLOSA)

Source: ClinicalTrials.gov · Last updated 30 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This interventional study has 2 parts. In the part A of the project, we will determine how the acute changes in hepatic fat content (HFC) after high-fat load (150 g of fat) are affected by co-administration with three doses of glucose, fructose, and sucrose. HFC in non-obese and obese male volunteers will be measured by magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) before and at the end of 6-hour intervention. The changes in triglycerides (TG), non-esterified fatty acids (NEFA), insulin and glucose will be also measured throughout the experiments. It can be expected that most of the obese subjects will also have a non-alcoholic fatty liver disease (NAFLD) and we will be therefore able to compare the HFC response between subjects with normal liver fat content and those with steatosis. Our previous results (doi: 10.26402/jpp.2021.1.05) clearly pointed out that glucose, contrary to fructose, prevents the storage of fat in the liver and that such an effect could be observed even after six hours. In the part B, we will therefore eliminate fructose from the diet of subjects with NAFLD of steatosis grade 2 for seven days - such an intervention will be isocaloric and fructose/sucrose will be replaced by starch or by glucose. The HFC content will be measured again by MRS and MRI after 168 hours. Very low density lipoprotein (VLDL), that transport TG out from the liver, will be isolated before and after intervention from the plasma obtained after overnight fasting. The analysis of lipid profile of the liver fat by MRS and fatty acid profile of TG in VLDL should provide an information on the role of de novo lipogenesis (DNL) in changes of HFC. In the part A of the project we will aim * to compare the response of HFC after high-fat load to repeated doses of glucose, fructose, and sucrose (3 x 50 g in two-hour intervals) * to compare such a response between non-obese and obese-subjects In the part B of the project we will aim * to find out whether short-term (7 days) restriction of fructose from the diet will decrease HFC in subjects with NAFLD * to find out whether such an intervention affects fatty acid profile of hepatic TG evaluated by MRS and by fatty acid profile of TG in VLDL - in this way we can estimate whether DNL is suppressed after fructose withdrawal * to further corroborate such an aim, we will also compare the fatty acid profile of plasma NEFA and that of TG in VLDL

Status (registry)
Recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
27 Nov 2024
Start date
20 Jun 2024
Primary completion date
Mar 2027
Lead sponsor
Institute for Clinical and Experimental Medicine
NCT number
NCT06751862

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 20 Jun 2024 to the primary completion date, Mar 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • use of drugs affecting lipid metabolism
    • Part B
  • use of drugs affecting lipid metabolism
  • intolerance of MR examination (claustrophobia, metal implants, etc.).

Other illness

  • other serious illnesses (cardiovascular disease, cancer, etc.)
  • other serious illnesses (cardiovascular disease, cancer, etc.)

Lab values

  • diabetes mellitus (fasting glucose above 7 mmol/l, 2-hour glucose after oGTT above 11.1 mmol/l, or antidiabetic treatment)
  • diabetes mellitus (fasting glucose above 7 mmol/l, 2-hour glucose after oGTT above 11.1 mmol/l, or antidiabetic treatment)

Other

  • alcohol consumption ˃ 30 g/day
  • fructose intolerance
  • alcohol consumption ˃ 30 g/day

Who the study is looking for

  • male volunteers - 15 nonobese subjects (Body Mass Index (BMI) \< 30 kg/m2) and 15 obese subjects (BMI ˃ 30 kg/m2)
  • 18 - 70 years old
  • male volunteers with hepatic fat content higher than 6.2% and less than 16.5%, which corresponds to steatosis grade 2 (S2)
  • 18 - 70 years old

Criteria the registry did not label

  • Part A

Age in the registry: 18 years to 70 years · Sex: Male · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institute for Clinical and Experimental Medicine
Coordinator of this site? Confirm its status
PragueCzechiaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.