Prevention of NAFLD and CVD Through Lifestyle Intervention (MAUCO+)

November 17, 2024 updated by: Catterina Ferreccio, Pontificia Universidad Catolica de Chile

Cardiovascular Diseases (CVD) and Nonalcoholic Fatty Liver Diseases (NAFLD) Among Gallstone and Cholecystectomy Patients and the Impact of a Novel Diet and Muscle Training Program

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND. Gallstone disease (GSD), including gallstones and cholecystectomy, is a common digestive disease worldwide, and Chile has one of the highest reported rates of gallstone prevalence. GSD, in particular cholecystectomy, has been associated with nonalcoholic fatty liver disease (NAFLD). In previous studies, investigators confirmed the association of cholecystectomy with a higher risk of NAFLD only in men. Additionally, reasearchers found a higher cardiovascular event risk in 3 years for male gallstone carriers. Investigators aim to step forward toward translational research by evaluating the effectiveness of a risk-reduction strategy customized to our population.

STUDY GOALS. To evaluate a metabolic risk reduction strategy based on: 1. A Physical exercise trial to increase muscle mass and strength, and 2. A nutritional intervention based on an anti-inflammatory diet, sleep hygiene, and prolonged fasting periods.

METHODS. Intensive Lifestyle Intervention, Randomized Controlled Trial: 300 participants will be randomly allocated to control (n=150) or an experimental group (n=150). The control group will receive standard prevention recommendations, personalized advice, educational material regarding lifestyle and metabolic diseases, and follow-up evaluation of physical activity, physical condition, anthropometry, diet, and sleep habits. The intervention group will receive, tailored to each participant: 3.1 An Exercise Program consisting of directly supervised and home-based telehealth sessions emphasizing muscle building, and 3.2. A Nutritional plus Program based on a diet rich in anti-inflammatory components and legumes, low in fat and refined carbohydrates, controlled energy according to BMI, extended nocturnal fasting periods, and healthy sleep habits. The programs will have a 6-month intensive phase of bi-weekly directly supervised exercise sessions in a municipality gym and a weekly telehealth session, followed by six months of telephone support and bi-monthly direct supervision to reinforce adherence and early identification of risk factors for abandonment. Intervention outcomes measured at baseline and years 1 and 2 are changes in non-invasive serum and ultrasound-based biomarkers of NAFLD; improvement in sarcopenia, aerobic capacity, body composition, lipid profile, insulin resistance, and cardiovascular risk; among overweight participants, permanent loss of at least 5% body weight; the decrease of depression symptoms, improvement of quality of life scores, and maintenance of a healthier lifestyle.

EXPECTED RESULTS: is expected that a 12-month intervention of a personalized physical activity program together with a metabolic protective diet will improve markers of metabolic syndrome and NAFLD and decrease CVD risk scores in all participants who adhere to more than 50% of both interventions, with a clear dose-response effect.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Chile
    • Region Del Maule
      • Molina, Region Del Maule, Chile
        • Recruiting
        • Centro MAUCO+
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other: Physical exercise and dietary intervention for NAFLD
Investigators will assess the efficiency of the intervention by measuring adherence to physical exercise and nutritional diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence and severity of Non-Alcoholic Fatty liver Disease (NAFLD) at baseline and 12 month later.
Time Frame: 36 months
It will be measured through the liver steatosis marker "Controlled Attenuation Parameter (CAP)" (dB/m).
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Framingham Cardiovascular risk score
Time Frame: 36 months
It will be measured at baseline and 12 months.
36 months
HDL cholesterol (mg/dL)
Time Frame: 36 months
It will be measured at baseline and 12 months.
36 months
Triglycerides (mg/dL)
Time Frame: 36 months
It will be measured at baseline and 12 months.
36 months
Glycemia (mg/dL)
Time Frame: 36 months
It will be measured at baseline and 12 months.
36 months
Insulin (uU/mL)
Time Frame: 36 months
It will be measured at baseline and 12 months.
36 months
HBA1c
Time Frame: 36 months
It will be measured at baseline and 12 months.
36 months
usPCR (mg/L)
Time Frame: 36 months
It will be measured at baseline and 12 months.
36 months
AST:ALT ratio
Time Frame: 36 months
It will be measured at baseline and 12 months.
36 months
Total cholesterol (mg/dL)
Time Frame: 36 months
It will be measured at baseline and 12 months.
36 months
Platelets (#cells/uL)
Time Frame: 36 months
It will be measured at baseline and 12 months.
36 months
HOMA-IR
Time Frame: 36 months
It will be measured at baseline and 12 months.
36 months
Total Bilirrubin (mg/dL)
Time Frame: 36 months
It will be measured at baseline and 12 months.
36 months
Alkaline phosphatase (UI/l)
Time Frame: 36 months
It will be measured at baseline and 12 months.
36 months
Glutamiz oxaloacetic transaminase (GOT) (UI/l)
Time Frame: 36 months
It will be measured at baseline and 12 months.
36 months
Glutamic pyruvic trasaminase (GPT) (UI/l)
Time Frame: 36 months
It will be measured at baseline and 12 months.
36 months
Gamma-glutamyl Transferase (GGT) (UI/l)
Time Frame: 36 months
It will be measured at baseline and 12 months.
36 months
Metabolic syndrome
Time Frame: 36 months
To be diagnosed with metabolic syndrome it is necessary to meet 3 or more conditions. (abdominal obesity, high triglycerides, low HDL cholesterol, high blood pressure and high fasting glucose). Metabolic syndrome will be measure at baseline and 12 month.
36 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscular mass percentage measure
Time Frame: 36 months
Muscular mass percentage will be measure by bioimpedance analysis at baseline and 12 month.
36 months
Body fat percentage
Time Frame: 36 months
Body fat percentage will be measure by bioimpedance analysis at baseline and 12 month.
36 months
Body Mass Index (BMI) (kg/m^2)
Time Frame: 36 months
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.
36 months
Aerobic capacity VO2max (ml/kg/min)
Time Frame: 36 months
Aerobic capacity VO2max will be measure at baseline and 12 month
36 months
Waist circumference (cm)
Time Frame: 36 months
Waist circumference will be measure at baseline and 12 month.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Investigators

  • Principal Investigator: Catterina Ferreccio, MD, Pontificia Universidad Catolica de Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2021

Primary Completion (Estimated)

April 28, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

June 17, 2022

First Submitted That Met QC Criteria

November 9, 2022

First Posted (Actual)

November 16, 2022

Study Record Updates

Last Update Posted (Estimated)

November 19, 2024

Last Update Submitted That Met QC Criteria

November 17, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FN1212066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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