Effects of Time-restricted Hypocaloric Diet in Patients With NAFLD

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

Effects of a Time-restricted Hypocaloric Mediterranean Diet in Patients With Non-alcoholic Fatty Liver Disease on Glucose Metabolism (CHRONO-NAFLD Project)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05866744
• Other study ID #: HRBD40/27.04.2022 716/26-11-22
• Status: Recruiting
• Phase: N/A
• Start date: May 8, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: May 2023
• Source: Agricultural University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The goal of this clinical trial is to evaluate the effects of the time in which food intake is restricted (morning or evening hours or no restriction in time) on glucose metabolism and liver steatosis in the context of a hypocaloric diet plan in 54 patients with non-alcoholic fatty liver disease (NAFLD). The participants will be divided into 3 groups of 18 individuals each and will be randomly assigned to one of the 3 dietary interventions. In the first group (control group), participants will be given a weight loss program based on the principles of the Mediterranean Diet (energy deficit of 500 kcal/day with the aim of losing 0.5 kg per week) with the instruction to consume their meals throughout the day, without time restriction. In the second group (early eaters), individuals will be given a weight loss program based on the principles of the Mediterranean Diet (energy deficit of 500 kcal/day with the aim of losing 0.5 kg per week), and they will be asked to consume all of their meals within 10 hours (between 07:00-09:00 and 17:00-19:00) and refrain from consuming caloric foods and drinks for the remaining 14 hours. In the third group (late eaters), individuals will be given a weight loss program based on the principles of the Mediterranean Diet (energy deficit of 500 kcal/day with the aim of losing 0.5 kg per week), and they will be asked to consume all of their meals within 10 hours (between 11:00-13:00 and 21:00-23:00) and refrain from consuming caloric foods and drinks for the remaining 14 hours. Finally, all groups will be instructed to moderately exercise for 150 minutes per week.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: July 30, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Other:
• Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet
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
• Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet
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
• Hypocaloric Mediterranean Diet Without Time Restriction In Feeding
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

Locations

Country	Name	City	State
Greece	Agricultural University of Athens	Athens	Attica
Greece	Laiko General Hospital of Athens	Athens	Attica

Sponsors (2)

Lead Sponsor	Collaborator
Agricultural University of Athens	Laik? General Hospital, Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood glucose concentrations	Clinically significant change in blood glucose concentrations (mg/dL)	12 weeks
Secondary	Change in body weight	Clinically significant change in body weight (kg)	12 weeks
Secondary	Change in blood insulin concentrations	Clinically significant change in blood insulin concentrations (µU/L)	12 weeks
Secondary	Change in Controlled Attenuation Parameter (CAP)	Clinically significant change in CAP (dB/m)	12 weeks
Secondary	Change in blood lipids levels	Clinically significant change in triglycerides (mg/dL), total cholesterol (mg/dL), low-density lipoprotein (mg/dL) and high-density lipoprotein (mg/dl)	12 weeks
Secondary	Change in Chronic Liver Disease Questionnaire (CLDQ)	Clinically significant change in health status within individuals with NAFLD. The CLDQ includes 29 items in the following domains: abdominal symptoms, fatigue, systemic symptoms, activity, emotional function and worry. Overall CLDQ scores calculated for each domain range from 1 (most impaired) to 7 (minimum frequency of symptoms). The total score is calculated as the average score of the 29 items.	12 weeks