An interventional study of Physical exercise and dietary intervention for NAFLD in Non-Alcoholic Fatty Liver Disease and Gallstone Disease, sponsored by Pontificia Universidad Catolica de Chile. Recruiting at 1 site in Chile. Open to participants aged 45 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-19.
Sponsored by Pontificia Universidad Catolica de Chile · Not applicable, Interventional, and Prevention
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.
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.
1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.
This study's planned enrollment of 300 is above the median of 60 across 1,176 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →Pontificia Universidad Catolica de Chile is the lead sponsor of 224 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Investigators will assess the efficiency of the intervention by measuring adherence to physical exercise and nutritional diet.
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).
Time frame: 36 months
Framingham Cardiovascular risk score
It will be measured at baseline and 12 months.
Time frame: 36 months
HDL cholesterol (mg/dL)
It will be measured at baseline and 12 months.
Time frame: 36 months
Triglycerides (mg/dL)
It will be measured at baseline and 12 months.
Time frame: 36 months
Glycemia (mg/dL)
It will be measured at baseline and 12 months.
Time frame: 36 months
Insulin (uU/mL)
It will be measured at baseline and 12 months.
Time frame: 36 months
HBA1c
It will be measured at baseline and 12 months.
Time frame: 36 months
usPCR (mg/L)
It will be measured at baseline and 12 months.
Time frame: 36 months
AST:ALT ratio
It will be measured at baseline and 12 months.
Time frame: 36 months
Total cholesterol (mg/dL)
It will be measured at baseline and 12 months.
Time frame: 36 months
Platelets (#cells/uL)
It will be measured at baseline and 12 months.
Time frame: 36 months
HOMA-IR
It will be measured at baseline and 12 months.
Time frame: 36 months
Total Bilirrubin (mg/dL)
It will be measured at baseline and 12 months.
Time frame: 36 months
Alkaline phosphatase (UI/l)
It will be measured at baseline and 12 months.
Time frame: 36 months
Glutamiz oxaloacetic transaminase (GOT) (UI/l)
It will be measured at baseline and 12 months.
Time frame: 36 months
Glutamic pyruvic trasaminase (GPT) (UI/l)
It will be measured at baseline and 12 months.
Time frame: 36 months
Gamma-glutamyl Transferase (GGT) (UI/l)
It will be measured at baseline and 12 months.
Time frame: 36 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.
Time frame: 36 months
Muscular mass percentage measure
Muscular mass percentage will be measure by bioimpedance analysis at baseline and 12 month.
Time frame: 36 months
Body fat percentage
Body fat percentage will be measure by bioimpedance analysis at baseline and 12 month.
Time frame: 36 months
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.
Time frame: 36 months
Aerobic capacity VO2max (ml/kg/min)
Aerobic capacity VO2max will be measure at baseline and 12 month
Time frame: 36 months
Waist circumference (cm)
Waist circumference will be measure at baseline and 12 month.
Time frame: 36 months
Plan to share: No
Started Sep 2021 (actual). Primary completion is estimated for Apr 2025, 43 months after the start.
Of 357 non-industry interventional studies with no phase under Non-alcoholic Fatty Liver Disease, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 51. This study's planned 43 months is above that.
Counting every sponsor, half of 385 studies reached it within 26 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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