Effects of Time-restricted Hypocaloric Diet in Patients with NAFLD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-08

Study Completion Date

2024-07-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non-Alcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet

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

Group Type EXPERIMENTAL

Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet

Intervention Type OTHER

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

Hypocaloric Mediterranean diet without time restriction in feeding

Group Type ACTIVE_COMPARATOR

Hypocaloric Mediterranean Diet Without Time Restriction In Feeding

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No