Study Results
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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RECRUITING
NA
100 participants
INTERVENTIONAL
2021-10-01
2024-12-01
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Intermittent fasting
This arm will undergo a TRF diet (Time-Restricted Feeding) for 12 weeks.
Intermittent fasting
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 diet
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.
DGE diet
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.
Interventions
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Intermittent fasting
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 diet
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Body Mass Index (BMI) \> 25 kg/m2
3. Grade 3 steatosis evaluated by with CAP ≥ 300 dB/m and exclusion of known causes of liver steatosis
4. Liver elastography \< 13 kPa
5. Capability to understand the study and the individual consequences of participation
6. Signed and dated declaration of agreement in the forefront of the study
Exclusion Criteria
2. Hepatocellular carcinoma or non-curative treated carcinoma
3. Alcohol consumption \>20g (female) und \>30 g (male)/day
4. 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
5. Medications which cause liver disease or secondary NAFLD (e. g. Tamoxifen, systemic Corticosteroids, Methotrexate, Tetracycline, Estrogens, Valproic acid)
6. Changes in body weight \> 5% in the last 6 months
7. Statins and/ or other fat-reducer medications if not taken in steady dosage during at least 4 weeks
8. Uncontrolled diabetes type 2 defined as HbA1c value \> 9.0% or insulin depending type 2 diabetes
9. Pregnancy
10. Immunologic or inflammatory disease (e. h. systemic lupus erythematodes)
11. Patients after organ transplantations
12. Missing or lacking consent capability
18 Years
75 Years
ALL
No
Sponsors
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University of Turin, Italy
OTHER
Johannes Gutenberg University Mainz
OTHER
Responsible Party
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Jörn M. Schattenberg
Prof. Dr. Jörn M. Schattenberg
Principal Investigators
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Jörn M. Schattenberg, Prof.
Role: PRINCIPAL_INVESTIGATOR
1. Medical Department
Locations
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University Medical Center of the Johannes Gutenberg Univeristy
Mainz, Rhineland-Palatinate, Germany
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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21-00784
Identifier Type: -
Identifier Source: org_study_id