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Effects of Time-restricted Hypocaloric Diet in Patients With NAFLD

Primary Purpose

Non-Alcoholic Fatty Liver Disease

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet
Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet
Hypocaloric Mediterranean Diet Without Time Restriction In Feeding
Sponsored by
Agricultural University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring Time-Restricted Feeding, Mediterranean Diet

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Laiko General Hospital of Athens
  • Agricultural University of AthensRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet

Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet

Hypocaloric Mediterranean Diet Without Time Restriction In Feeding

Arm Description

Early 14:10 time-restricted feeding plus hypocaloric Mediterranean diet

Late 14:10 time-restricted feeding plus hypocaloric Mediterranean diet

Hypocaloric Mediterranean diet without time restriction in feeding

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in body weight
Clinically significant change in body weight (kg)
Change in blood insulin concentrations
Clinically significant change in blood insulin concentrations (μU/L)
Change in Controlled Attenuation Parameter (CAP)
Clinically significant change in CAP (dB/m)
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)
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.

Full Information

First Posted
March 30, 2023
Last Updated
May 10, 2023
Sponsor
Agricultural University of Athens
Collaborators
Laikο General Hospital, Athens
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1. Study Identification

Unique Protocol Identification Number
NCT05866744
Brief Title
Effects of Time-restricted Hypocaloric Diet in Patients With NAFLD
Official Title
Effects of a Time-restricted Hypocaloric Mediterranean Diet in Patients With Non-alcoholic Fatty Liver Disease on Glucose Metabolism (CHRONO-NAFLD Project)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
July 15, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Agricultural University of Athens
Collaborators
Laikο General Hospital, Athens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease
Keywords
Time-Restricted Feeding, Mediterranean Diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet
Arm Type
Experimental
Arm Description
Early 14:10 time-restricted feeding plus hypocaloric Mediterranean diet
Arm Title
Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet
Arm Type
Experimental
Arm Description
Late 14:10 time-restricted feeding plus hypocaloric Mediterranean diet
Arm Title
Hypocaloric Mediterranean Diet Without Time Restriction In Feeding
Arm Type
Active Comparator
Arm Description
Hypocaloric Mediterranean diet without time restriction in feeding
Intervention Type
Other
Intervention Name(s)
Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Hypocaloric Mediterranean Diet Without Time Restriction In Feeding
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in blood glucose concentrations
Description
Clinically significant change in blood glucose concentrations (mg/dL)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in body weight
Description
Clinically significant change in body weight (kg)
Time Frame
12 weeks
Title
Change in blood insulin concentrations
Description
Clinically significant change in blood insulin concentrations (μU/L)
Time Frame
12 weeks
Title
Change in Controlled Attenuation Parameter (CAP)
Description
Clinically significant change in CAP (dB/m)
Time Frame
12 weeks
Title
Change in blood lipids levels
Description
Clinically significant change in triglycerides (mg/dL), total cholesterol (mg/dL), low-density lipoprotein (mg/dL) and high-density lipoprotein (mg/dl)
Time Frame
12 weeks
Title
Change in Chronic Liver Disease Questionnaire (CLDQ)
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Laiko General Hospital of Athens
City
Athens
State/Province
Attica
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evangelos Cholongitas, MD, PhD
Phone
+302132061643
Email
echolog@med.uoa.gr
First Name & Middle Initial & Last Name & Degree
Evangelos Cholongitas, MD, PhD
Phone
+302132061643
Email
cholongitas@yahoo.gr
Facility Name
Agricultural University of Athens
City
Athens
State/Province
Attica
ZIP/Postal Code
11855
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aimilia Papakonstantinou, PhD
Phone
+302105294967
Email
apapakonstantinou@gmail.com
First Name & Middle Initial & Last Name & Degree
Emilia Papakonstantinou, PhD
Phone
+302105294967
Email
emiliap@aua.gr

12. IPD Sharing Statement

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Effects of Time-restricted Hypocaloric Diet in Patients With NAFLD

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