NCT07366463Completed
Integrating Hepatological, Nutritional, and Psychological Support as a Multidisciplinary Management to Improve Long-term Clinical Outcomes in MASLD
Integrating Hepatological, Nutritional, and Cognitive Behavioral Therapy-based Psychological Support is an Effective Multidisciplinary Approach to Improve Long-term Clinical Outcomes in the Management of MASLD Patients: a Randomized Clinical Trial [The "CoCoNut" Study]
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
Metabolic dysfunction associated Steatotic Liver Disease (MASLD) is frequently complicated by cardiometabolic (CMR) comorbidities, and prognosis is substantially influenced by acute cardiovascular events (ACE). Although several pharmacological approaches target CMR risk factors, lifestyle modification remains the cornerstone of management. However, adherence to dietary behavioral prescriptions is often poor, and the influence of sociodemographic determinants on compliance remains unclear. Moreover, the long-term real-life impact of behavioral and motivational support in MASLD is insufficiently characterized. This randomized controlled trial aims to evaluate the effectiveness of a multidisciplinary management (including Hepatological counseling, Nutrition intervention, and Psychological support) in improving clinical MASLD outcomes, by increasing adherence to specialist-tailored recommendations.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 286 (actual)
- First submitted
- 30 Dec 2025
- Start date
- 1 Jul 2023
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07366463
What you commit to
- Study type: Interventional
- Participants enrolled: 286
- From 1 Jul 2023 to the primary completion date, 1 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- hepatoprotective drugs administration,
- consumption of hypoglycemic, hypolipidemic, and weight loss agents, as well as any drug known to influence liver function,
Other illness
- chronic liver diseases other than MASLD/overlap ongoing causes (including chronic hepatitis B virus infection, chronic hepatitis C virus infection, autoimmune hepatitis, chronic cholestasis, genetic diseases determining steatosis, and alcohol-related liver disorder assumed in the evidence of a history of alcohol intake greater than 20 g/day or 140 g/week),
- administration of liver-damaging (Drug-induced liver Injury) (DILI) / hepatic steatosis inducing drugs (Drug-Induced Fatty Liver Disease) (DIFLD),
- chronic systemic inflammatory diseases,
- eating disorders (ED)
- other psychiatric disorders potentially invalidating the consent.
Other
- unavailability or inability to express written consent,
- neoplasms,
Who the study is looking for
- age between 40 and 79 years,
- a diagnosis of MASLD, configured by the presence of hepatic steatosis (proven by instrumental and/or histological methods), with at least one of the five cardiometabolic risk factors (CMRFs) as established by the updated multi-society Delphi consensus proposed criteria,
- willingness to sign a valid informed consent
Age in the registry: 40 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Campania "Luigi Vanvitelli" Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.