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Coffee Consumption and NASH in the French Population.

Coffee Consumption and NASH in the French Population.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03432377
Acronym
COCANASH
Enrollment
107
Registered
2018-02-14
Start date
2017-11-15
Completion date
2020-11-17
Last updated
2021-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Alcoholic Steatohepatitis

Brief summary

The aim of our study is to evaluate the effect of coffee consumption on the risk of severe liver fibrosis in French patients with NASH.

Interventions

None listed

Sponsors

Versailles Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Any newly diagnosed case of NASH histologically proven graded according to SAF criteria Or Metabolic syndrome defined by the IDF 2005 criteria: * waist size\> 94cm (men) or\> 80cm (women) * and the presence of at least two of the following criteria: * blood pressure: Systolic ≥ 130mmHg OR diastolic ≥ 85 mmHg OR antihypertensive treatment * Triglycerides ≥ 1.5g / L or lipid-lowering therapy * HDL cholesterol \<0.4 g / L (men) or \<0.5 g / L (women) or lipid-lowering therapy * fasting blood glucose:\> 1 g / L or type 2 diabetes AND Hepatic steatosis diagnosed on liver imaging And liver fibrosis (diagnosed with a FibroScan\> 6 KPa)

Exclusion criteria

* Age \<18 years * Viral hepatitis and other chronic liver diseases * Alcohol consumption\> 20g / day for women, 30g / day for men * Liver biopsy or FibroScan dating more than 6 months before inclusion. * History of bariatric surgery * Serious psychiatric pathology (psychosis, dementia, severe depression) and patients under legal protection (tutelage, guardianship) * Solid cancer or progressive hematology or \<2 years (except basal cell carcinoma or localized squamous cell carcinoma) * Severe and terminal chronic renal insufficiency (estimated GFR \<30mL / min) * Recent myocardial infarction \<6 months

Design outcomes

Primary

MeasureTime frame
To compare coffee caffeine consumption in NASH patients with early (F1-2) vs advanced (F3-4) liver fibrosis in univariate analysis and after adjustment for potential confounding factors.Day 0

Secondary

MeasureTime frame
Evaluation of the correlation between the degree of hepatic fibrosis assessed by elastometry (FibroScan) or the histological stage and the caffeine consumption from coffee in univariate analysis and after adjustment for potential confounding factors.Day 0
Comparison of the percentage of regular coffee drinkers in NASH patients with early (F1-2) vs advanced (F3-4) liver fibrosis in univariate analysis and after adjustment for potential confounding factors.Day 0
Comparison of total caffeine consumption from all types of drinks in patients with NASH with early (F1-2) vs advanced (F3-4) liver fibrosis in univariate analysis and after adjustment for potential confounding factors.Day 0

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026