CompletedNot Applicable

Effects of Time-restricted Hypocaloric Diet in Patients with NAFLD

Greece59 participantsStarted 2023-05-08

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Body Mass Index \>25 kg/m2 * Liver steatosis with Magnetic Resonance Elastography (MRE) Exclusion Criteria: * Other chronic liver diseases * Alcohol consumption \>20 g/day (female) and \>30 g/day (male) * Medications that cause liver disease or secondary NAFLD (e.g. tamoxifen, corticosteroids, Methotrexate, tetracycline, estrogens, valproic acid) * 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 * Unstable glucose-lowering medications in the last 6 months * Body weight lowering medications and/or history of bariatric surgery * Statins and/ or other fat-reducing medications if not taken in steady dosage for at least 3 months * Uncontrolled type 2 diabetes mellitus defined as HbA1c value \> 9.0% or insulin depending type 1 and 2 diabetes mellitus * Pregnancy * Lactation * Immunologic or inflammatory diseases * Depression and other psychiatric diseases * Patients working in shifts * Cancer

What they're measuring

Change in blood glucose concentrations

Timeframe: 12 weeks

Trial details

NCT IDNCT05866744

SponsorAgricultural University of Athens

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-15

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