Prevention of NAFLD and CVD Through Lifestyle Intervention

NCT05618626 | Recruiting DMC

• 1 other identifier: FN1212066
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Alcoholic Fatty Liver Disease; Gallstone Disease

Keywords

Anti-inflammatory diet; Lifestyle modification; Physical Activity

Outcome Measures

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).

  36 months

Secondary Outcomes (17)

• Framingham Cardiovascular risk score

  36 months

• HDL cholesterol (mg/dL)

  36 months

• Triglycerides (mg/dL)

  36 months

• Glycemia (mg/dL)

  36 months

• Insulin (uU/mL)

  36 months

Other Outcomes (5)

• Muscular mass percentage measure

  36 months

• Body fat percentage

  36 months

• Body Mass Index (BMI) (kg/m^2)

  36 months

Study Arms (2)

Physical exercise and dietary intervention for NAFLD

EXPERIMENTAL

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.

Other: Physical exercise and dietary intervention for NAFLD

Standard of care

NO INTERVENTION

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.

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.

Physical exercise and dietary intervention for NAFLD

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• With and without gallstones disease
• With various degrees of NAFLD (none too severe)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Centro MAUCO+

Molina, Maule Region, Chile

RECRUITING

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MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Cholelithiasis; Motor Activity

Interventions

Exercise; Diet Therapy

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Biliary Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutrition Therapy; Therapeutics

Study Officials

• Catterina Ferreccio, MD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura A Huidobro, PhD

CONTACT

+56 9 9219 6618; leahuidobro@gmail.com

Catterina Ferreccio, MD

CONTACT

+56 9 95788658; catferre@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: November 16, 2022
• Study Start: September 27, 2021
• Primary Completion: April 28, 2025
• Study Completion: April 30, 2025
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)