Non-Alcoholic Fatty Liver DiseaseNCT05866744
Effects of Time-restricted Hypocaloric Diet in Patients with NAFLD
A study testing Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet, Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet and Hypocaloric Mediterranean Diet Without Time Restriction In Feeding in people with Non-Alcoholic Fatty Liver Disease, run by Agricultural University of Athens at 2 sites in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet, Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet and Hypocaloric Mediterranean Diet Without Time Restriction In Feeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 2 sitesGreece
- Study dates
- 8 May 2023to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index >25 kg/m2
- Liver steatosis with Magnetic Resonance Elastography (MRE)
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Laiko General Hospital of Athens
Athens, Attica, 11527
Agricultural University of Athens
Athens, Attica, 11855
About this study
Official title: Effects of a Time-restricted Hypocaloric Mediterranean Diet in Patients with Non-alcoholic Fatty Liver Disease on Glucose Metabolism (CHRONO-NAFLD Project)
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.
Read the 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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet, Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet, Hypocaloric Mediterranean Diet Without Time Restriction In Feeding
- Keywords
- Time-Restricted Feeding, Mediterranean Diet
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Time-Restricted Feeding Plus Hypocaloric Mediterranean DietOther
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 DietOther
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 FeedingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet | Experimental | Early 14:10 time-restricted feeding plus hypocaloric Mediterranean diet Receives: Other: Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet |
| Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet | Experimental | Late 14:10 time-restricted feeding plus hypocaloric Mediterranean diet Receives: Other: Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet |
| Hypocaloric Mediterranean Diet Without Time Restriction In Feeding | Active comparator | Hypocaloric Mediterranean diet without time restriction in feeding Receives: Other: Hypocaloric Mediterranean Diet Without Time Restriction In Feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood glucose concentrations
Clinically significant change in blood glucose concentrations (mg/dL)
Measured: 12 weeks
Secondary outcomes (5)
Change in body weight
Clinically significant change in body weight (kg)
Measured: 12 weeks
Change in blood insulin concentrations
Clinically significant change in blood insulin concentrations (μU/L)
Measured: 12 weeks
Change in Controlled Attenuation Parameter (CAP)
Clinically significant change in CAP (dB/m)
Measured: 12 weeks
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)
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start8 May 2023
- Primary completion15 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agricultural University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Laikο General Hospital, Athens
- Responsible party
- Principal investigator, Aimilia Papakonstantinou, Agricultural University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866744
- Sponsor's protocol ID
- HRBD40/27.04.2022 716/26-11-22
- Status last verified
- Oct 2024
- First submitted
- 30 Mar 2023
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40017349
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Time-restricted Hypocaloric Mediterranean Diet in Patients with Non-alcoholic Fatty Liver Disease on Glucose Metabolism (CHRONO-NAFLD Project)
- ClinicalTrials.gov ID
- NCT05866744
- Acronym / sponsor ID
- HRBD40/27.04.2022 716/26-11-22
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- Time-Restricted Feeding, Mediterranean Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Agricultural University of AthensUniversity, hospital or other
- Collaborators
- Laikο General Hospital, Athens
- Study start
- 8 May 2023 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet | Experimental | Other: Early Time-Restricted Feeding Plus Hypocaloric Mediterranean DietEarly 14:10 time-restricted feeding plus hypocaloric Mediterranean diet |
| Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet | Experimental | Other: Late Time-Restricted Feeding Plus Hypocaloric Mediterranean DietLate 14:10 time-restricted feeding plus hypocaloric Mediterranean diet |
| Hypocaloric Mediterranean Diet Without Time Restriction In Feeding | Active comparator | Other: Hypocaloric Mediterranean Diet Without Time Restriction In FeedingHypocaloric Mediterranean diet without time restriction in feeding |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body Mass Index >25 kg/m2
- Liver steatosis with Magnetic Resonance Elastography (MRE)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet18 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 | Other | Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet |
| Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet18 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 | Other | Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet |
| Hypocaloric Mediterranean Diet Without Time Restriction In Feeding18 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 | Other | Hypocaloric Mediterranean Diet Without Time Restriction In Feeding |
Primary outcome
Change in blood glucose concentrations
Time frame: 12 weeks
Clinically significant change in blood glucose concentrations (mg/dL)
5 secondary outcomes
Change in body weight
Time frame: 12 weeks
Change in blood insulin concentrations
Time frame: 12 weeks
Change in Controlled Attenuation Parameter (CAP)
Time frame: 12 weeks
Change in blood lipids levels
Time frame: 12 weeks
Change in Chronic Liver Disease Questionnaire (CLDQ)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Derived from this study: PubMed 40017349Tsitsou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet, Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet and Hypocaloric Mediterranean Diet Without Time Restriction In Feeding in people with Non-Alcoholic Fatty Liver Disease, run by Agricultural University of Athens at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood glucose concentrations (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05866744, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.