Prevention of NAFLD and CVD Through Lifestyle Intervention

Sponsor
Pontificia Universidad Catolica de Chile
Study ID
NCT05618626
Status
Recruiting
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Conditions

  • Gallstone Disease
  • Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

Sex
ALL
Age
45 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Physical exercise and dietary intervention for NAFLD — OTHER
    Investigators will assess the efficiency of the intervention by measuring adherence to physical exercise and nutritional diet.

Study Details

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.

Key Dates

First listed
Nov 16, 2022
Start date
Sep 27, 2021
Status verified
Nov 2024
Primary completion
Apr 28, 2025
Completion
Apr 30, 2025

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Physical exercise and dietary intervention for NAFLD
    The exercise program will consist of muscular strength and aerobic exercises; additionally, each session will start and end with low intensity warm-up and cool down periods. The program will be divided in months. Months 1-2, twice a week directly-supervised exercises group sessions, and 1 telehealth session. Months 3-6, once a week directly-supervised group session and twice a week home-based telehealth. Months 7-12, Monthly telephone support. Months 12, 24 and 36, All participants (control and intervention arms) will receive a full evaluation. In the dietary intervention, investigators proposed a diet rich in anti-inflammatory components, legumes and in dietary fiber. The baseline evaluation of nutritional condition includes: anthropometry, bioimpedance analysis, hepatobiliary ultrasound, Fibroscan,blood lipids, and a battery of metabolic markers and a diet survey, Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24). Both interventions are performed in parallel.
  • No Intervention: Standard of care
    Participants in the control arm first have a baseline evaluation of the nutritional condition, with anthropometry evaluation, bioimpedance analysis, hepatobiliary ultrasound, Fibroscan, blood lipids, a battery of metabolic markers, and a diet survey, Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24). After the evaluation period, participants received one counseling session, including written material, with advice to follow a healthy diet rich in fruits and vegetables, whole-grain foods, low in salt and sugars, and recommendations for an exercise plan of at least 30 minutes of aerobic exercise three times a week.

Primary Outcome Measure

Presence and severity of Non-Alcoholic Fatty liver Disease (NAFLD) at baseline and 12 month later. [ Time Frame: 36 months ]

Central Contacts

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