Prevention of NAFLD and CVD Through Lifestyle Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-60
SponsorPontificia Universidad Catolica de Chile
About this trial
Prevention of non-alcoholic fatty liver disease (NAFLD) and cardiovascular disease (CVD) through lifestyle intervention (MAUCO+) is a clinical trial that aims to improve sarcopenia, aerobic capacity, body composition, and lipid profile, insulin resistance, cardiovascular risk, NAFLD, and maintain a healthier lifestyle. Through the implementation of physical activity and nutritional programs.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
With and without gallstones disease
With various degrees of NAFLD (none too severe)
Disqualifiers
Any significant comorbidity or physical limitation to undergo resistance exercise program
Use of medications that alter muscle mass (e.g., corticosteroids)
History of hepatitis B or C
Use of hepatotoxic drugs
Trial design
Design model
Parallel
Treatments tested in this trial
Physical exercise and dietary intervention for NAFLD
Other interventionInvestigators will assess the efficiency of the intervention by measuring adherence to physical exercise and nutritional diet.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Physical exercise and dietary intervention for NAFLDExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Presence and severity of Non-Alcoholic Fatty liver Disease (NAFLD) at baseline and 12 month later.
It will be measured through the liver steatosis marker "Controlled Attenuation Parameter (CAP)" (dB/m).
Time frame
36 monthsSecondary outcomes
1
Framingham Cardiovascular risk score
It will be measured at baseline and 12 months.
Time frame
36 months2
HDL cholesterol (mg/dL)
It will be measured at baseline and 12 months.
Time frame
36 months3
Triglycerides (mg/dL)
It will be measured at baseline and 12 months.
Time frame
36 months4
Glycemia (mg/dL)
It will be measured at baseline and 12 months.
Time frame
36 monthsOther outcomes
1
Muscular mass percentage measure
Muscular mass percentage will be measure by bioimpedance analysis at baseline and 12 month.
Time frame
36 months2
Body fat percentage
Body fat percentage will be measure by bioimpedance analysis at baseline and 12 month.
Time frame
36 months3
Body Mass Index (BMI) (kg/m^2)
A BMI will considered Underweight, Normal, Overweight or Obesity if it is less than 18.5 kg/m\^2, it is between 18.5 and 24.9 kg/m\^2, it is between 25 and 29.9 kg/m\^2, or it is equal or greater than 30 kg/m\^2, respectively.
Time frame
36 months4
Aerobic capacity VO2max (ml/kg/min)
Aerobic capacity VO2max will be measure at baseline and 12 month
Time frame
36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov