The Clock Thickens: Morning or Evening Training for the Treatment of NAFLD?

NCT05987748 | Unknown DMC

• 1 other identifier: NL83431.058.22
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the different effect of morning and evening exercise training in individuals with non-alcoholic fatty liver disease (NAFLD). The main question it aims to answer is: • Is morning or evening exercise better for the treatment of NAFLD? Participants will follow a supervised exercise training program for three months with either morning or evening training and the effect on liver health will be assessed. Researchers will compare the morning to the evening exercise group to see if one training timepoint is more effective than the other in reducing the amount of fat in the liver and improving liver health.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Exercise; Circadian rhythms

Outcome Measures

Primary Outcomes (1)

• Liver fat content

  Liver fat content (in %) will be measured by MRI LiverMultiScan

  12 weeks

Secondary Outcomes (13)

• Hepatic fibrosis

  12 weeks

• Body mass index (BMI)

  12 weeks

• Fecal microbiota

  12 weeks

• Cardiorespiratory fitness

  12 weeks

• Waist circumference

  12 weeks

Study Arms (2)

Morning exercise

EXPERIMENTAL

Individuals will exercise train at 8 AM three times per week for 12 weeks.

Behavioral: Exercise training

Evening exercise

EXPERIMENTAL

Individuals will exercise train at 8 PM three times per week for 12 weeks.

Behavioral: Exercise training

Interventions

Exercise training BEHAVIORAL

Mixed exercise training containing strength and endurance elements carried out under supervision

Evening exercise; Morning exercise

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Maag Lever Darm Stichting: collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

Location

Related Publications (29)

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MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Milena Schönke, PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Milena Schönke, PhD

CONTACT

+31715268188; m.schoenke@lumc.nl

Maarten E Tushuizen, MD PhD

CONTACT

m.e.tushuizen@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 14, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Starting at publication
• Access Criteria: IPD that underlie results in a publication will be made available upon reasonable request

Locations

NL (1)