The Clock thickens: Morning or evening training for the treatment of NAFLD?

Conditions: fatty liver disease
hepatic steatosis
10019654
10013317

Registration Number: NL-OMON53691

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

- Age >= 45 years and <= 75
- Obese (BMI > 27 kg/m2)
- Males and postmenopausal females
- Caucasian
- Hepatic steatosis defined as increased hyperechogenicity of the liver on
abdominal ultrasound, CAP score on Fibroscan > 280, and/or histological signs
of steatosis
- Sedentary lifestyle (maximum of 20*minutes of moderate-to-vigorous physical
activity per day on less than three days per week)
- Written informed consent

Exclusion Criteria

- Exclusion criteria for MRI (claustrophobia, pacemaker, metal implants, etc.)
- Any other liver disease than NAFLD/NASH
- Present excessive alcohol use defined as > 2 units/day
- Recent use (< 3 months) of antibiotics
- Recent changes in dosages of regular medication (< 3 months)
- Recent (< 3 months) weight change (>5%)
- Recent (< 3 months) substantial diet changes
- Cardiovascular co-morbidity defined as heart failure, coronary insufficiency
and hypertension in past history
- Comorbidity that contraindicates exercise training and exercise testing or
that affects exercise response and exercise capacity
- Ongoing or recent use of glucocorticoids, oral/transdermal hormonal
substitution, paclitaxel, theofyllin, amiodarone, myelosuppresive agents
- A psychiatric, addictive or any other disorder that compromises the subjects
ability to understand the study content and to give written informed consent
for participation in the study
- Working night or alternating shifts, known sleeping disorders such as
narcolepsy or insomnia

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the study is the reduction of liver fat levels and<br /><br>other markers of NAFLD after 12 weeks of morning or evening exercise.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include the improvement of insulin resistance, circulating<br /><br>levels of liver enzymes, fitness, and gut microbiota composition in response to<br /><br>morning or evening exercise.</p><br>