An interventional study of Mediterranean diet and Low fat diet in Non-alcoholic Fatty Liver Disease and Obesity, sponsored by University of Roma La Sapienza. Completed at 1 site in Italy. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-27.
Sponsored by University of Roma La Sapienza · Not applicable, Interventional, and Basic science
Nonalcoholic fatty liver disease (NAFLD) is associated to obesity, metabolic syndrome and genetic predisposition: specific variants of the genes PNPLA3 and TM6SF2 are the most involved. Also biochemical mechanisms that affect the "metabolic flexibility" need to be better clarified.
It is known that a dietary intervention, accompanied by a physical personalized training, reduce either the hepatic fat content either insulin resistance.
Therefore, the aim of the study is to evaluate "metabolic flexibility" in obese NAFLD subjects taking in account the presence or absence of PNPLA3 and TM6SF2 polymorphism and the histopathological diagnosis of either simple steatosis or nonalcoholic steatohepatitis (NASH). The composition of gut microbiota will be also evaluated.
Finally, two distinct healthy dietary profiles accompanied by a personalized physical training, will be tested to comprehend whether and how "healthy diets" could operate in the clinical treatment of NAFLD and related conditions.
Nonalcoholic fatty liver disease (NAFLD) is frequently associated to obesity and metabolic syndrome. In NAFLD, a heritable component to disease susceptibility has been demonstrated: the variants of the genes PNPLA3 and TM6SF2 are the most involved genetic determinants.
To date, biochemical mechanisms that affect the "metabolic flexibility" in obese NAFLD subjects, in presence or absence of genetic susceptibility, need to be better clarified.
Different studies demonstrated that a dietary intervention, accompanied by a physical personalized training, significantly reduce either the hepatic fat content either insulin resistance in overweight and obese subjects, independently of weight loss.
On these bases, the aim of the study is to evaluate "metabolic flexibility" in obese NAFLD subjects taking in account their genetics (presence or absence of PNPLA3 and TM6SF2 polymorphisms) and the histopathological diagnosis of either simple steatosis or nonalcoholic steatohepatitis (NASH). In addition, the composition of gut microbiota will be evaluated.
Finally, in this study, two distinct healthy dietary profiles accompanied by a personalized physical training, will be tested in order to comprehend whether and how "healthy diets" could be effective not only in the prevention, but also in the clinical treatment of NAFLD and other related conditions.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 120 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →University of Roma La Sapienza is the lead sponsor of 388 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
Hypocaloric Mediterranean diet for a 4-month period; Aerobic exercise training for a 4-month period;
Dietary Supplement: Mediterranean diet · Other: Aerobic exercise
Hypocaloric low fat diet supplemented by branched and essential amino acids considering the total protein intake for a 4- month period; Aerobic exercise training for a 4- month period;
Dietary Supplement: Low fat diet · Other: Aerobic exercise
In the Mediterranean diet fat intake will be equal to 35% of the total energy intake minus carbohydrate and protein energy carbohydrate as 65% of total calorie intake, dietary cholesterol \<300 mg/day, dietary fiber 25 g/day.
In the hypocaloric low fat diet, fat will represent less than 25% of the total energy intake. Branched and essential amino acids will be administered taking into account the total protein intake.
A personalized program of aerobic exercise will be prescribed to the participants of both arms, following the "FITT" principles (frequency, intensity, time and type).
Cholesterol assessment
total cholesterol, HDL- cholesterol, LDL- cholesterol levels reported as mg/dl
Time frame: baseline
Cholesterol assessment
total cholesterol, HDL- cholesterol, LDL- cholesterol levels reported as mg/dl
Time frame: 18 weeks after baseline
triglycerides assessment
tryglicerides levels reported as mg/dl
Time frame: baseline
triglycerides assessment
tryglicerides levels reported as mg/dl
Time frame: 18 weeks after baseline
metabolic flexibility variation in liver function;
alanine aminotransferase (ALT) \[U/L\] , aspartate aminotransferase (AST) \[UI/L\]
Time frame: baseline
metabolic flexibility variation in liver function;
alanine aminotransferase (ALT) \[U/L\] , aspartate aminotransferase (AST) \[UI/L\]
Time frame: 18 weeks after baseline
Waist circumference measurements;
waist circumference reported as cm
Time frame: baseline
Waist circumference measurements;
waist circumference reported as cm
Time frame: 18 weeks after baseline
anthropometric measurements;
Body mass index reported as kg/m\^2
Time frame: baseline
anthropometric measurements;
Body mass index reported as kg/m\^2
Time frame: 18 weeks after baseline
Ultrasonographic examination;
Liver ultrasonography according with criteria by Hamaguchi
Time frame: baseline
Ultrasonographic examination;
Liver ultrasonography according with criteria by Hamaguchi
Time frame: 18 weeks after baseline
Glucidic profile
fasting glucose reported as mg/dl
Time frame: baseline
Glucidic profile
fasting glucose reported as mg/dl
Time frame: 18 weeks after baseline
Insulinemia
insulin reported as µU/mL
Time frame: baseline
Insulinemia
insulin reported as µU/mL
Time frame: 18 weeks after baseline
Plan to share: No
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University of Roma La Sapienza