NCT05866744Completed
Effects of Time-restricted Hypocaloric Diet in Patients with NAFLD
Effects of a Time-restricted Hypocaloric Mediterranean Diet in Patients with Non-alcoholic Fatty Liver Disease on Glucose Metabolism (CHRONO-NAFLD Project)
Source: ClinicalTrials.gov · Last updated 30 Oct 2024
Brief summary (registry, in English)
The effects of a time-restricted hypocaloric Mediterranean type diet compared to a conventional hypocaloric Mediterranean type diet on blood glucose metabolism and liver steatosis in people with non-alcoholic fatty liver disease will be investigated.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 59 (actual)
- First submitted
- 30 Mar 2023
- Start date
- 8 May 2023
- Primary completion date
- 15 Jul 2024
- Lead sponsor
- Agricultural University of Athens
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05866744
What you commit to
- Study type: Interventional
- Participants enrolled: 59
- From 8 May 2023 to the primary completion date, 15 Jul 2024
- 2 sites 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
- Statins and/ or other fat-reducing medications if not taken in steady dosage for at least 3 months
Other illness
- Other chronic liver diseases
- Medications that cause liver disease or secondary NAFLD (e.g. tamoxifen, corticosteroids, Methotrexate, tetracycline, estrogens, valproic acid)
- Body weight lowering medications and/or history of bariatric surgery
- Immunologic or inflammatory diseases
- Depression and other psychiatric diseases
- Cancer
Lab values
- Unstable glucose-lowering medications in the last 6 months
- Uncontrolled type 2 diabetes mellitus defined as HbA1c value \> 9.0% or insulin depending type 1 and 2 diabetes mellitus
Other
- Alcohol consumption \>20 g/day (female) and \>30 g/day (male)
- Changes in body weight ± 3 % in the last 3 months
- Patients following a hypocaloric diet program and/or time-restricted feeding and/or other intermittent fasting protocols
- Pregnancy
- Lactation
- Patients working in shifts
Who the study is looking for
- Body Mass Index \>25 kg/m2
- Liver steatosis with Magnetic Resonance Elastography (MRE)
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Laiko General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Agricultural University of Athens Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.