Effects of Time-restricted Hypocaloric Diet in Patients With NAFLD

• Sponsor: Agricultural University of Athens (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05866744
• Collaborator: Laikο General Hospital, Athens (Other)
• Enrollment: 54
• Locations: 2
• Arms: 3
• Anticipated Duration (Months): 14.8
• Patients Per Site: 27
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Alcoholic Fatty Liver Disease	Other: Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet; Other: Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet; Other: Hypocaloric Mediterranean Diet Without Time Restriction In Feeding	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of a Time-restricted Hypocaloric Mediterranean Diet in Patients With Non-alcoholic Fatty Liver Disease on Glucose Metabolism (CHRONO-NAFLD Project)
• Actual Study Start Date: May 8, 2023
• Anticipated Primary Completion Date: Jul 15, 2024
• Anticipated Study Completion Date: Jul 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet Early 14:10 time-restricted feeding plus hypocaloric Mediterranean diet	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
Experimental: Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet Late 14:10 time-restricted feeding plus hypocaloric Mediterranean diet	Other: 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
Active Comparator: Hypocaloric Mediterranean Diet Without Time Restriction In Feeding Hypocaloric Mediterranean diet without time restriction in feeding	Other: 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

Outcome Measures

Primary Outcome Measures

1. Change in blood glucose concentrations [12 weeks]

   Clinically significant change in blood glucose concentrations (mg/dL)

Secondary Outcome Measures

1. Change in body weight [12 weeks]

   Clinically significant change in body weight (kg)

2. Change in blood insulin concentrations [12 weeks]

   Clinically significant change in blood insulin concentrations (μU/L)

3. Change in Controlled Attenuation Parameter (CAP) [12 weeks]

   Clinically significant change in CAP (dB/m)

4. Change in blood lipids levels [12 weeks]

   Clinically significant change in triglycerides (mg/dL), total cholesterol (mg/dL), low-density lipoprotein (mg/dL) and high-density lipoprotein (mg/dl)

5. Change in Chronic Liver Disease Questionnaire (CLDQ) [12 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laiko General Hospital of Athens	Athens	Attica	Greece	11527
2	Agricultural University of Athens	Athens	Attica	Greece	11855

Sponsors and Collaborators

• Agricultural University of Athens
• Laikο General Hospital, Athens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aimilia Papakonstantinou, Assistant Professor, Agricultural University of Athens
• ClinicalTrials.gov Identifier: NCT05866744
• Other Study ID Numbers: HRBD40/27.04.2022 716/26-11-22
• First Posted: May 19, 2023
• Last Update Posted: May 19, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Aimilia Papakonstantinou, Assistant Professor, Agricultural University of Athens: Time-Restricted Feeding; Mediterranean Diet
• Additional relevant MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of May 19, 2023