Prevention of NAFLD and CVD Through Lifestyle Intervention

Non-Alcoholic Fatty Liver Disease Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05618626
• Other study ID #: FN1212066
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2021
• Est. completion date: April 30, 2025

Study information

• Verified date: January 2023
• Source: Pontificia Universidad Catolica de Chile
• Contact: Laura A Huidobro, PhD
• Phone: +56 9 9219 6618
• Email: leahuidobro[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 30, 2025
• Est. primary completion date: April 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Fatty Liver
• Gallstone Disease
• Gallstones
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

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.

Locations

Country	Name	City	State
Chile	Centro MAUCO+	Molina	Region Del Maule

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

References & Publications (101)

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Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Muscular mass percentage measure	Muscular mass percentage will be measure by bioimpedance analysis at baseline and 12 month.	36 months
Other	Body fat percentage	Body fat percentage will be measure by bioimpedance analysis at baseline and 12 month.	36 months
Other	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.	36 months
Other	Aerobic capacity VO2max (ml/kg/min)	Aerobic capacity VO2max will be measure at baseline and 12 month	36 months
Other	Waist circumference (cm)	Waist circumference will be measure at baseline and 12 month.	36 months
Primary	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	Framingham Cardiovascular risk score	It will be measured at baseline and 12 months.	36 months
Secondary	HDL cholesterol (mg/dL)	It will be measured at baseline and 12 months.	36 months
Secondary	Triglycerides (mg/dL)	It will be measured at baseline and 12 months.	36 months
Secondary	Glycemia (mg/dL)	It will be measured at baseline and 12 months.	36 months
Secondary	Insulin (uU/mL)	It will be measured at baseline and 12 months.	36 months
Secondary	HBA1c	It will be measured at baseline and 12 months.	36 months
Secondary	usPCR (mg/L)	It will be measured at baseline and 12 months.	36 months
Secondary	AST:ALT ratio	It will be measured at baseline and 12 months.	36 months
Secondary	Total cholesterol (mg/dL)	It will be measured at baseline and 12 months.	36 months
Secondary	Platelets (#cells/uL)	It will be measured at baseline and 12 months.	36 months
Secondary	HOMA-IR	It will be measured at baseline and 12 months.	36 months
Secondary	Total Bilirrubin (mg/dL)	It will be measured at baseline and 12 months.	36 months
Secondary	Alkaline phosphatase (UI/l)	It will be measured at baseline and 12 months.	36 months
Secondary	Glutamiz oxaloacetic transaminase (GOT) (UI/l)	It will be measured at baseline and 12 months.	36 months
Secondary	Glutamic pyruvic trasaminase (GPT) (UI/l)	It will be measured at baseline and 12 months.	36 months
Secondary	Gamma-glutamyl Transferase (GGT) (UI/l)	It will be measured at baseline and 12 months.	36 months
Secondary	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.	36 months