Skip to content

NAFLD: Independent Effects of Western Dietary Pattern Profile and Sedentary Life

NAFLD: Independent Effects of Western Dietary Pattern Profile and Sedentary Life

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02670590
Acronym
ct-NAFLD
Enrollment
150
Registered
2016-02-02
Start date
2011-01-31
Completion date
2014-12-31
Last updated
2017-07-11

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

Conditions

Fatty Liver

Brief summary

Investigators perform a counseling intervention study (6 months) in adult subjects with evidence of Fatty Liver by Ultrasound, graded 0-3 according to the Bright Liver Score (BLS); exclusion criteria are diabetes, renal insufficiency (glomerular filtration rate \< 90 ml/min), cancer, heart failure \> II NYHA ( New York Heart Association) Class), chronic virus hepatitis, and cirrhosis. Insulin resistance was assessed as homeostasis model assessment-insulin resistance (HOMA-IR) . Suggestions and advice on individual healthy food purchase, storage, and cooking were given. Reliable feedback and evidence of patients' adherence were obtained by scheduled dietician's interviews. Investigators will challenge the predictive effects of the Adherence to Mediterranean Diet, of Western dietary profile score and of increased physical activity at 6 months in a body mass index changes-balanced model to detect independent effects, if any, of the studied variable on NAFLD persistence, amelioration or disappearance. Threshold and odds of Mediterranean and Western dietary profile score will be calculated by contingency tables and receiver operator characteristic curve (ROC) analysis..

Detailed description

Dietary and physical exercise counseling.

Interventions

BEHAVIORALdiet

diet

Sponsors

Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* clinical diagnosis of fatty liver

Exclusion criteria

* type I or type II diabetes, * no alcohol, cancer, malnutrition, severe obesity, renal insufficiency, viral hepatitis, other chronic disease

Design outcomes

Primary

MeasureTime frame
Decrease of fatty liver appearance by ultrasound6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026