Fatty Liver DiseaseNAFLD-TRFNCT05220956
Impact of Time-restricted Feeding in NAFLD
A study testing Intermittent fasting and DGE diet in people with Fatty Liver Disease and Fatty Liver, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
This is a randomised controlled study of patients with Non-Alcoholic Fatty Liver Disease (NAFLD). Patients will be trained according to the 10 rules of a healthy nutrition according to the German Association for Nutrition (DGE). One arm will undergo Time-Restricted Feeding (TRF) for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fatty Liver Disease, Fatty Liver, Fatty Liver, Nonalcoholic
- What is being tested?
- Intermittent fasting and DGE diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2021to 1 Dec 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
Patients with steady medication during the last 3 months. A diabetes mellitus must not be decompensated (HbA1c <6.5%). Patients with advanced fibrosis - defined about the non-invasive Fibroscan-procedure (Fibroscan >13 kPa) - will not be included.
Complete inclusion criteria:
- Age between 18 and 75 years
- Body Mass Index (BMI) > 25 kg/m2
- Grade 3 steatosis evaluated by with CAP ≥ 300 dB/m and exclusion of known causes of liver steatosis
- Liver elastography < 13 kPa
- Capability to understand the study and the individual consequences of participation
- Signed and dated declaration of agreement in the forefront of the study
Complete exclusion criteria:
- Liver cirrhosis
- Hepatocellular carcinoma or non-curative treated carcinoma
- Alcohol consumption >20g (female) und >30 g (male)/day
- Other causes of chronic liver disease (HBV, HCV, HDV, HEV, HIV), autoimmune diseases or chronic cholestatic liver disease, hereditary haemochromatosis, Wilson disease, α-1-Antitrypsin deficiency
- Medications which cause liver disease or secondary NAFLD (e. g. Tamoxifen, systemic Corticosteroids, Methotrexate, Tetracycline, Estrogens, Valproic acid)
- Changes in body weight > 5% in the last 6 months
- Statins and/ or other fat-reducer medications if not taken in steady dosage during at least 4 weeks
- Uncontrolled diabetes type 2 defined as HbA1c value > 9.0% or insulin depending type 2 diabetes
- Pregnancy
- Immunologic or inflammatory disease (e. h. systemic lupus erythematodes)
- Patients after organ transplantations
- Missing or lacking consent capability
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center of the Johannes Gutenberg Univeristy
Mainz, Rhineland-Palatinate, 55131
06131 ext. 17-0
Jörn M Schattenberg, Prof.
About this study
Official title: Impact of Time-restricted Feeding on Hepatic Steatosis in NAFLD
This is a randomised controlled study of patients with Non-Alcoholic Fatty Liver Disease (NAFLD).
Patients will be trained according to the 10 rules of a healthy nutrition according to the German Association for Nutrition (DGE).
One arm will undergo Time-Restricted Feeding (TRF) for 12 weeks. The control arm is not subject to any time restrictions concerning eating.
It will be investigated whether TRF improves insulin sensitivity, impacts on metabolic inflammation and reduces liver steatosis.
Read the detailed description
Patients are recruited in the Liver Outpatient Clinic of the University Medical Center of Mainz.
About 100 patients will be enrolled in this pilot study. Inclusions criteria are exclusions of known causes of liver injury, Body Mass Index (BMI) > 25 kg/m^2, severe steatosis according to CAP ≥ 300 dB/m and absence of advanced fibrosis according to liver stiffness < 13 kPa.
Following the written consent, all patients will be trained to undertake a 2-week lead-in period of DGE.
Beginning in week 3 (Visit 2), an interventional group and a control group are generated through randomisation. The interventional group is instructed to follow TRF, whereas the control group is not subject to any time restrictions. Both arms will be accompanied for a duration of 12 weeks.TRF diet is based on temporal food consumption between 8:00 a.m. and 16:00 p.m., thus a 16 hour lasting period. After 10 weeks from the completion of the experimental phase (wash-out period), there will be the "end of follow up" visit.
The whole duration of the study is 24 weeks (2 weeks lead-in, 12 weeks intervention and 10 weeks post-intervention investigation).
Transient elastography (Fibroscan) is conducted at the screening visit, randomization visit, and at weeks 8, end of treatment visit and end of study visit. Spleen stiffness measurement is performed at randomization visit, week 8 and end of treatment visit. There will be 5 visits at the study center (screening, randomization, week 8, end of treatment and end of study) and 2 phone visits (week 6 and week 12). At each visit clinical events, body weight and standard laboratory parameters, identification of the CAP and stiffness values will be collected. Participants will fill in questionnaires capturing quality of life. At randomization visit and end of treatment visit, an OGTT will be performed to assess insulin sensitivity.
Adverse events will be recorded. Phone visits are used to survey the safety of patients.
Non-adherence to TRF for 2 days per week (20% of the total study period) has been selected as cut off to define treatment failure at per-protocol analysis.
- Conditions
- Fatty Liver Disease, Fatty Liver, Fatty Liver, Nonalcoholic
- Being tested
- Intermittent fasting, DGE diet
- Keywords
- liver fibrosis, time restricted feeding
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Liver Cirrhosis, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent fastingBehavioural
Also called Time restricted feeding
One arm will undergo a TRF diet (Time-Restricted Feeding) for 12 weeks while both arms undergo a training according to the 10 rules of healthy nutrition of the DGE.
DGE dietBehavioural
The control arm is not a subject to any time restrictions concerning eating while both arms undergo a training according to the 10 rules of healthy nutrition of the DGE.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent fasting | Other | This arm will undergo a TRF diet (Time-Restricted Feeding) for 12 weeks. Receives: Behavioral: Intermittent fasting |
| DGE diet | Other | This control arm is not a subject to any time restrictions concerning eating, solely patients will be trained according to the 10 rules of healthy nutrition of the DGE. Receives: Behavioral: DGE diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the impact of TRF on liver steatosis by CAP (dB/m)
The primary outcome of interest is a change in CAP value of a least 20 db/m with TRF
Measured: 12 weeks
Secondary outcomes (9)
Changes in liver fibrosis by liver stiffness (kPa) under TRF
Liver elastography performed as surrogate marker of liver fibrosis
Measured: 12 weeks
Changes in FIB-4 as indirect non-invasive tools of liver fibrosis
Changes in the surrogate marker of liver fibrosis FIB-4
Measured: 12 weeks
Evaluation of changes in direct non-invasive tool of liver fibrosis ELF
Performed as surrogate markers of liver fibrosis
Measured: 12 weeks
Evaluation of changes in direct marker of liver fibrogenesis PRO-C3 (ng/ml)
Performed as surrogate markers of liver fibrosis
Measured: 12 weeks
Evaluation of changes in liver-specific quality of life
Evaluation of Patient Reported Outcomes using the Chronic Liver Disease Questionnaire (CLDQ). The CLDQ uses 29 items in four domains, each scored on a Likert scale from 1 (all of the time) to 7 (none of the time) representing the frequency of clinical symptoms and emotional problems in the last two weeks. Results are reported in the six subscale scores (abdominal symptoms, fatigue, systemic symptoms, activity, emotional functioning, worry) and a CLDQ overall score.
Measured: 12 weeks
Evaluation of changes in insulin sensitivity
Changes in insulin sensitivity by indexes derived by HOMA-IR score
Measured: 12 weeks
Evaluation of changes in the gut microbiota
Evaluation of 16S rRNA gene sequencing for species and strain-level microbiome analysis.
Measured: 12 weeks
Evaluation of changes in markers of oxidative stress (AGEs)
AGEs as surrogate markers of oxidative stress
Measured: 12 weeks
Changes in spleen volume by spleen stiffness under TRF
Spleen stiffness performed as surrogate of spleen volume
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 posted2 Feb 2022
- Study start1 Oct 2021
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomised controlled study with NAFLD-patients. One arm will undergo a TRF diet (Time-Restricted Feeding) for 12 weeks. The control arm is not subject to any time restrictions concerning eating.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turin, Italy
- Responsible party
- Principal investigator, Jörn M. Schattenberg, Johannes Gutenberg University Mainz
- Investigators
- Jörn M. Schattenberg, Prof., Principal investigator, 1. Medical Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220956
- Sponsor's protocol ID
- 21-00784
- Acronym
- NAFLD-TRF
- Status last verified
- Dec 2023
- First submitted
- 22 Jun 2021
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The transfer of data to third parties including publication will be exclusively in form of double pseudo-anonymized data, i.e. cannot be assigned to a person.
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Time-restricted Feeding on Hepatic Steatosis in NAFLD
- ClinicalTrials.gov ID
- NCT05220956
- Acronym / sponsor ID
- NAFLD-TRF / 21-00784
- Conditions
- Fatty Liver Disease, Fatty Liver, Fatty Liver, Nonalcoholic
- Keywords
- liver fibrosis, time restricted feeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- University of Turin, Italy
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 2 Feb 2022 (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.
This is a randomised controlled study of patients with Non-Alcoholic Fatty Liver Disease (NAFLD).
Patients will be trained according to the 10 rules of a healthy nutrition according to the German Association for Nutrition (DGE).
One arm will undergo Time-Restricted Feeding (TRF) for 12 weeks. The control arm is not subject to any time restrictions concerning eating.
It will be investigated whether TRF improves insulin sensitivity, impacts on metabolic inflammation and reduces liver steatosis.
Detailed description
Patients are recruited in the Liver Outpatient Clinic of the University Medical Center of Mainz.
About 100 patients will be enrolled in this pilot study. Inclusions criteria are exclusions of known causes of liver injury, Body Mass Index (BMI) > 25 kg/m^2, severe steatosis according to CAP ≥ 300 dB/m and absence of advanced fibrosis according to liver stiffness < 13 kPa.
Following the written consent, all patients will be trained to undertake a 2-week lead-in period of DGE.
Beginning in week 3 (Visit 2), an interventional group and a control group are generated through randomisation. The interventional group is instructed to follow TRF, whereas the control group is not subject to any time restrictions. Both arms will be accompanied for a duration of 12 weeks.TRF diet is based on temporal food consumption between 8:00 a.m. and 16:00 p.m., thus a 16 hour lasting period. After 10 weeks from the completion of the experimental phase (wash-out period), there will be the "end of follow up" visit.
The whole duration of the study is 24 weeks (2 weeks lead-in, 12 weeks intervention and 10 weeks post-intervention investigation).
Transient elastography (Fibroscan) is conducted at the screening visit, randomization visit, and at weeks 8, end of treatment visit and end of study visit. Spleen stiffness measurement is performed at randomization visit, week 8 and end of treatment visit. There will be 5 visits at the study center (screening, randomization, week 8, end of treatment and end of study) and 2 phone visits (week 6 and week 12). At each visit clinical events, body weight and standard laboratory parameters, identification of the CAP and stiffness values will be collected. Participants will fill in questionnaires capturing quality of life. At randomization visit and end of treatment visit, an OGTT will be performed to assess insulin sensitivity.
Adverse events will be recorded. Phone visits are used to survey the safety of patients.
Non-adherence to TRF for 2 days per week (20% of the total study period) has been selected as cut off to define treatment failure at per-protocol analysis.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomised controlled study with NAFLD-patients. One arm will undergo a TRF diet (Time-Restricted Feeding) for 12 weeks. The control arm is not subject to any time restrictions concerning eating.
| Arm | Type | Receives |
|---|---|---|
| Intermittent fasting | Other | Behavioral: Intermittent fastingThis arm will undergo a TRF diet (Time-Restricted Feeding) for 12 weeks. |
| DGE diet | Other | Behavioral: DGE dietThis control arm is not a subject to any time restrictions concerning eating, solely patients will be trained according to the 10 rules of healthy nutrition of the DGE. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Intermittent fastingAlso: Time restricted feedingOne arm will undergo a TRF diet (Time-Restricted Feeding) for 12 weeks while both arms undergo a training according to the 10 rules of healthy nutrition of the DGE. | Behavioural | Intermittent fasting |
| DGE dietThe control arm is not a subject to any time restrictions concerning eating while both arms undergo a training according to the 10 rules of healthy nutrition of the DGE. | Behavioural | DGE diet |
Primary outcome
Evaluation of the impact of TRF on liver steatosis by CAP (dB/m)
Time frame: 12 weeks
The primary outcome of interest is a change in CAP value of a least 20 db/m with TRF
9 secondary outcomes
Changes in liver fibrosis by liver stiffness (kPa) under TRF
Time frame: 12 weeks
Changes in FIB-4 as indirect non-invasive tools of liver fibrosis
Time frame: 12 weeks
Evaluation of changes in direct non-invasive tool of liver fibrosis ELF
Time frame: 12 weeks
Evaluation of changes in direct marker of liver fibrogenesis PRO-C3 (ng/ml)
Time frame: 12 weeks
Evaluation of changes in liver-specific quality of life
Time frame: 12 weeks
Evaluation of changes in insulin sensitivity
Time frame: 12 weeks
Evaluation of changes in the gut microbiota
Time frame: 12 weeks
Evaluation of changes in markers of oxidative stress (AGEs)
Time frame: 12 weeks
Changes in spleen volume by spleen stiffness under TRF
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Individual participant dataSharing planned: No. The transfer of data to third parties including publication will be exclusively in form of double pseudo-anonymized data, i.e. cannot be assigned to a person.
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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.
Jörn M. Schattenberg, Prof. principal investigator
1. Medical Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent fasting and DGE diet in people with Fatty Liver Disease and Fatty Liver, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jörn M. Schattenberg, Prof. (06131-17 ext. 6074, joern.schattenberg@unimedizin-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the impact of TRF on liver steatosis by CAP (dB/m) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Dec 2023.