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

Primary Purpose

Non-Alcoholic Fatty Liver Disease, Gallstone Disease

Status
Recruiting
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Physical exercise and dietary intervention for NAFLD
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Non-Alcoholic Fatty Liver Disease focused on measuring Anti-inflammatory diet, Lifestyle modification, Physical Activity

Eligibility Criteria

45 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centro MAUCO+Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Physical exercise and dietary intervention for NAFLD

Standard of care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Framingham Cardiovascular risk score
It will be measured at baseline and 12 months.
HDL cholesterol (mg/dL)
It will be measured at baseline and 12 months.
Triglycerides (mg/dL)
It will be measured at baseline and 12 months.
Glycemia (mg/dL)
It will be measured at baseline and 12 months.
Insulin (uU/mL)
It will be measured at baseline and 12 months.
HBA1c
It will be measured at baseline and 12 months.
usPCR (mg/L)
It will be measured at baseline and 12 months.
AST:ALT ratio
It will be measured at baseline and 12 months.
Total cholesterol (mg/dL)
It will be measured at baseline and 12 months.
Platelets (#cells/uL)
It will be measured at baseline and 12 months.
HOMA-IR
It will be measured at baseline and 12 months.
Total Bilirrubin (mg/dL)
It will be measured at baseline and 12 months.
Alkaline phosphatase (UI/l)
It will be measured at baseline and 12 months.
Glutamiz oxaloacetic transaminase (GOT) (UI/l)
It will be measured at baseline and 12 months.
Glutamic pyruvic trasaminase (GPT) (UI/l)
It will be measured at baseline and 12 months.
Gamma-glutamyl Transferase (GGT) (UI/l)
It will be measured at baseline and 12 months.
Metabolic syndrome
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.

Full Information

First Posted
June 17, 2022
Last Updated
January 20, 2023
Sponsor
Pontificia Universidad Catolica de Chile
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1. Study Identification

Unique Protocol Identification Number
NCT05618626
Brief Title
Prevention of NAFLD and CVD Through Lifestyle Intervention
Acronym
MAUCO+
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2021 (Actual)
Primary Completion Date
April 28, 2023 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pontificia Universidad Catolica de Chile

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease, Gallstone Disease
Keywords
Anti-inflammatory diet, Lifestyle modification, Physical Activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical exercise and dietary intervention for NAFLD
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Physical exercise and dietary intervention for NAFLD
Intervention Description
Investigators will assess the efficiency of the intervention by measuring adherence to physical exercise and nutritional diet.
Primary Outcome Measure Information:
Title
Presence and severity of Non-Alcoholic Fatty liver Disease (NAFLD) at baseline and 12 month later.
Description
It will be measured through the liver steatosis marker "Controlled Attenuation Parameter (CAP)" (dB/m).
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Framingham Cardiovascular risk score
Description
It will be measured at baseline and 12 months.
Time Frame
36 months
Title
HDL cholesterol (mg/dL)
Description
It will be measured at baseline and 12 months.
Time Frame
36 months
Title
Triglycerides (mg/dL)
Description
It will be measured at baseline and 12 months.
Time Frame
36 months
Title
Glycemia (mg/dL)
Description
It will be measured at baseline and 12 months.
Time Frame
36 months
Title
Insulin (uU/mL)
Description
It will be measured at baseline and 12 months.
Time Frame
36 months
Title
HBA1c
Description
It will be measured at baseline and 12 months.
Time Frame
36 months
Title
usPCR (mg/L)
Description
It will be measured at baseline and 12 months.
Time Frame
36 months
Title
AST:ALT ratio
Description
It will be measured at baseline and 12 months.
Time Frame
36 months
Title
Total cholesterol (mg/dL)
Description
It will be measured at baseline and 12 months.
Time Frame
36 months
Title
Platelets (#cells/uL)
Description
It will be measured at baseline and 12 months.
Time Frame
36 months
Title
HOMA-IR
Description
It will be measured at baseline and 12 months.
Time Frame
36 months
Title
Total Bilirrubin (mg/dL)
Description
It will be measured at baseline and 12 months.
Time Frame
36 months
Title
Alkaline phosphatase (UI/l)
Description
It will be measured at baseline and 12 months.
Time Frame
36 months
Title
Glutamiz oxaloacetic transaminase (GOT) (UI/l)
Description
It will be measured at baseline and 12 months.
Time Frame
36 months
Title
Glutamic pyruvic trasaminase (GPT) (UI/l)
Description
It will be measured at baseline and 12 months.
Time Frame
36 months
Title
Gamma-glutamyl Transferase (GGT) (UI/l)
Description
It will be measured at baseline and 12 months.
Time Frame
36 months
Title
Metabolic syndrome
Description
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.
Time Frame
36 months
Other Pre-specified Outcome Measures:
Title
Muscular mass percentage measure
Description
Muscular mass percentage will be measure by bioimpedance analysis at baseline and 12 month.
Time Frame
36 months
Title
Body fat percentage
Description
Body fat percentage will be measure by bioimpedance analysis at baseline and 12 month.
Time Frame
36 months
Title
Body Mass Index (BMI) (kg/m^2)
Description
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 months
Title
Aerobic capacity VO2max (ml/kg/min)
Description
Aerobic capacity VO2max will be measure at baseline and 12 month
Time Frame
36 months
Title
Waist circumference (cm)
Description
Waist circumference will be measure at baseline and 12 month.
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura A Huidobro, PhD
Phone
+56 9 9219 6618
Email
leahuidobro@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Catterina Ferreccio, MD
Phone
+56 9 95788658
Email
catferre@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catterina Ferreccio, MD
Organizational Affiliation
Pontificia Universidad Catolica de Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro MAUCO+
City
Molina
State/Province
Region Del Maule
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura A Huidobro, MD, PhD
Email
ahuidobro@ucm.cl

12. IPD Sharing Statement

Plan to Share IPD
No
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Prevention of NAFLD and CVD Through Lifestyle Intervention

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