Clinical trial NCT02347696: Diet and Physical Activity on NAFLD and Erytrocyte Membrane Lipid Profile.
Official title: Effect of Two Programs of Physical Activity of Different Intensity, Mediterranean Diet and the Combination of Both on NAFLD and Erytrocyte Membrane Lipid Profile.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: NAFLD
Keywords: Diet
Physical Activity
Trial
Lipidomics
Occidental Diseases
Lead sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Sponsor class: OTHER
First posted: 2015-01-27
Enrollment: 240
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effect of two programs of different intensity level of physical activity, of low glycemic index Mediterranean Diet and of the interaction of both, on NAFLD score and on the lipid composition of the erythrocyte membrane.

Detailed description: The surveys conducted on the populations of Castellana Grotte and Putignano (Bari, Italy) evidenced that Non-Alcoholic Fatty liver Disease (NAFLD) reaches a prevalence of 30%, especially among aged and male individuals. Being a crucial outcome of several metabolic alterations, it becomes imperative for Public Health to adopt strategies aimed to control the factors responsible for NAFLD onset.

The objective of this study is to evaluate the effect of two programs of different intensity level of physical activity, of low glycemic index Mediterranean Diet and of the interaction of both, on NAFLD score and on the lipid composition of the erythrocyte membrane.

Study participants responding to the inclusion criteria of this trial will be chosen both in the hospital setting and in the general practitioners' clinics. At the enrollement, anthropometric and biochemical variables will be measured, as well as bioimpedenziometric and calorimetric parameters; participants will also undergo Fibroscan-CAP to measure the outcome and will be asked about their medical history and life-style. Subjects will be randomized to the different arms of the trial and be followed-up at the end of the sixth and the twelfth week of enrollement.

All data will be statistically analysed by applying the Chi-Square test and t-test for discrete and continuous variables, respectively. As it deals with the analysis of data repeatedly measured on the same subject, the Generalized Estimating Equation (GEE) will be applied to evaluate the effect of the intervention on the outcomes.

Eligibility criteria: Inclusion Criteria:

* BMI ≥ 25.0
* Moderate or severe NAFLD
* 30 \< age \<60

Exclusion Criteria:

* Overt cardiovascular disease and revascularization procedures;
* Stroke;
* Clinical peripheral artery disease;
* Type-2 Diabetes Mellitus (current treatment with insulin or oral hypoglycemic drugs, fasting glucose \>126 mg/dl, or casual glucose \>200 mg/dl);
* Severe medical condition that may impair the person to participate in a nutritional intervention study;
* Impossibility to follow Mediterranean Diet for religious or other reasons.

Primary outcomes:
measure: Non-Alcoholic Fatty liver Disease (NAFLD) score
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Lipid composition of erythrocyte membrane
timeFrame: 6 and 12 weeks
measure: Sierical lipid profile
timeFrame: 6 and 12 weeks
Other outcomes:
Locations:
city: Castellana Grotte
country: Italy
facility: Laboratory of Epidemiology and Biostatistics-IRCCS Saverio de Bellis
state: BA
Study officials:
affiliation: IRCCS "Saverio De Bellis"
name: Alberto R Osella, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: