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OpenTrials
Completed

NCT Number: NCT03432377

Coffee Consumption and NASH in the French Population.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de Béziers, Béziers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: Day 0

Secondary outcomes

  1. 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.

    Time frame: Day 0

  2. 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.

    Time frame: Day 0

  3. 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.

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Versailles Hospital

Other

Registry information

Acronym: COCANASH

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 14, 2018
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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