Investigating how sugars affect fat accumulation in the liver
The Effect of Simple Carbohydrates on the Development of Non-alcoholic Fatty Liver Disease (FROGLOSA)
This study tests how different types of sugars affect fat buildup in the liver of men, both non-obese and obese, to help understand better ways to manage liver health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Male |
| Sponsor | Institute for Clinical and Experimental Medicine Government |
| Locations | 1 site (Prague, Czech Republic) |
| Trial ID | NCT06751862 on ClinicalTrials.gov |
What this trial studies
This interventional study examines the impact of different sugars on hepatic fat content in male volunteers, both non-obese and obese. Participants will undergo a high-fat load intervention while receiving glucose, fructose, or sucrose, with measurements taken using magnetic resonance imaging and spectroscopy. The study aims to understand how these sugars influence fat storage in the liver, particularly in relation to non-alcoholic fatty liver disease (NAFLD). The findings could provide insights into dietary recommendations for managing liver health.
Who should consider this trial
Good fit: Ideal candidates include male volunteers aged 18-70, both non-obese and obese, with specific BMI criteria.
Not a fit: Patients with diabetes, serious illnesses, or those who consume excessive alcohol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better dietary guidelines for preventing and managing fatty liver disease.
How similar studies have performed: Previous studies have indicated a link between sugar intake and liver fat accumulation, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Part A Inclusion Criteria: * male volunteers - 15 nonobese subjects (Body Mass Index (BMI) \< 30 kg/m2) and 15 obese subjects (BMI ˃ 30 kg/m2) * 18 - 70 years old Exclusion Criteria: * diabetes mellitus (fasting glucose above 7 mmol/l, 2-hour glucose after oGTT above 11.1 mmol/l, or antidiabetic treatment) * other serious illnesses (cardiovascular disease, cancer, etc.) * alcohol consumption ˃ 30 g/day * fructose intolerance * use of drugs affecting lipid metabolism Part B Inclusion Criteria: * 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 Exclusion Criteria: * diabetes mellitus (fasting glucose above 7 mmol/l, 2-hour glucose after oGTT above 11.1 mmol/l, or antidiabetic treatment) * other serious illnesses (cardiovascular disease, cancer, etc.) * alcohol consumption ˃ 30 g/day * use of drugs affecting lipid metabolism * intolerance of MR examination (claustrophobia, metal implants, etc.).
Where this trial is running
Prague, Czech Republic
- Institute for Clinical and Experimental Medicine — Prague, Czech Republic, Czechia (Recruiting)
Study contacts
- Principal investigator: Dita Pajuelo, PhD — Institute for Clinical and Experimental Medicine
- Study coordinator: Jan Kovář, PhD
- Email: nkov@ikem.cz
- Phone: 00420236053369
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.