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)
1 other identifier
interventional
59
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2023
CompletedStudy Start
First participant enrolled
May 8, 2023
CompletedFirst Posted
Study publicly available on registry
May 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2024
CompletedOctober 30, 2024
October 1, 2024
1.2 years
March 30, 2023
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in blood glucose concentrations
Clinically significant change in blood glucose concentrations (mg/dL)
12 weeks
Secondary Outcomes (5)
Change in body weight
12 weeks
Change in blood insulin concentrations
12 weeks
Change in Controlled Attenuation Parameter (CAP)
12 weeks
Change in blood lipids levels
12 weeks
Change in Chronic Liver Disease Questionnaire (CLDQ)
12 weeks
Study Arms (3)
Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet
EXPERIMENTALEarly 14:10 time-restricted feeding plus hypocaloric Mediterranean diet
Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet
EXPERIMENTALLate 14:10 time-restricted feeding plus hypocaloric Mediterranean diet
Hypocaloric Mediterranean Diet Without Time Restriction In Feeding
ACTIVE COMPARATORHypocaloric Mediterranean diet without time restriction in feeding
Interventions
18 patients with NAFLD will be asked to follow an early 14:10 (14 hours fasting and 10 hours feeding) time-restricted (eating between 08:00-18:00) and individualized Mediterranean diet plan with caloric restriction (energy deficit of 500 kcal/day) for 12 weeks
18 patients with NAFLD will be asked to follow a late 14:10 (14 hours fasting and 10 hours feeding) time-restricted (eating between 12:00-22:00) and individualized Mediterranean diet plan with caloric restriction (energy deficit of 500 kcal/day) for 12 weeks
18 patients with NAFLD will be asked to follow an individualized Mediterranean diet plan with caloric restriction (energy deficit of 500 kcal/day) without time restriction in feeding (eating throughout the day) for 12 weeks
Eligibility Criteria
You may qualify if:
- Body Mass Index \>25 kg/m2
- Liver steatosis with Magnetic Resonance Elastography (MRE)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Agricultural University of Athenslead
- Laikο General Hospital, Athenscollaborator
Study Sites (2)
Laiko General Hospital of Athens
Athens, Attica, 11527, Greece
Agricultural University of Athens
Athens, Attica, 11855, Greece
Related Publications (1)
Tsitsou S, Bali T, Adamantou M, Saridaki A, Poulia KA, Karagiannakis DS, Papakonstantinou E, Cholongitas E. Effects of a 12-Week Mediterranean-Type Time-Restricted Feeding Protocol in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease: A Randomised Controlled Trial-The 'CHRONO-NAFLD Project'. Aliment Pharmacol Ther. 2025 Apr;61(8):1290-1309. doi: 10.1111/apt.70044. Epub 2025 Feb 28.
PMID: 40017349DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 30, 2023
First Posted
May 19, 2023
Study Start
May 8, 2023
Primary Completion
July 15, 2024
Study Completion
July 30, 2024
Last Updated
October 30, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share