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Adherence to the Mediterranean Diet and Circulating Levels of Sirtuin 4 in Obese Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02840981
Recruitment Status : Completed
First Posted : July 21, 2016
Last Update Posted : July 21, 2016
Information provided by (Responsible Party):
Prof. Silvia Savastano, Federico II University

Brief Summary:

The Mediterranean diet (MD), a healthy dietary pattern based on some common dietary characteristics in Mediterranean countries, is associated with high antioxidant capacity linked to the low saturated fat intake that might contribute to reduce free fatty acid (FFA) availability and oxidation in mitochondria, thus reducing the production of the reactive oxygen species (ROS) superoxide, and promoting cellular health. To assess the adherence to the MD, a simple 14-item questionnaire had been tested in different settings by the PREDIMED (PREvención con DIeta MEDiterránea) multicenter, randomized, primary prevention trial. On the other hand, to allow a more an accurate measurement of the actual macro and micronutrient intakes, including dietary anti-oxidant micronutrients, the 7-day food records is considered as the "gold standard" of self-administered food frequency questionnaires.

Circulating levels of Sirtuin 4 (Sirt4), part of a complex of proteins that control diverse biological processes, including lipid metabolism, are low in obese patients, as a possible attempt to decrease fat oxidative capacity and mitochondrial ROS production, however promoting ectopic liver fat storage.

The phase angle (PA), a measure determined by bioelectrical impedance analysis (BIA), and the visceral adiposity index (VAI), a gender-specific mathematical index based on simple anthropometric and metabolic parameters, represent well-validated, reliable and widely used markers of cellular health and ectopic adipose distribution and function, respectively. The fatty liver index (FLI) is a surrogate measure for fatty liver recently proposed as an independent predictor for diabetes mellitus.

Aim of the present study was to investigate in adult obese individuals the levels of Sirt4 according to the adherence to the MD evaluated by PREDIMED questionnaire, focusing on the possible association with single dietary components evaluated by 7-day food records, and to evaluate the association between circulating levels of Sirt4 and PA, as marker of cellular health, VAI, as index of adipocyte dysfunction, and FLI, as a predictor of fatty liver.

Condition or disease
Mediterranean Diet Nutrition Sirtuin 4 Obesity

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Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Obese Patients Adhering to Mediterranean Diet Show Less Reduced Circulating Levels of Sirtuin 4
Study Start Date : December 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Primary Outcome Measures :
  1. Adherence to Mediterranean Diet by Predimed Questionnaire [ Time Frame: December 2013 to September 2015 ]
  2. Circulating Levels of Sirtuin 4 by ELISA method [ Time Frame: December 2013 to September 2015 ]
  3. Obesity by Body Mass Index [ Time Frame: December 2013 to September 2015 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
257 consecutive obese subjects visiting the out-patient Obesity Unit of the Section of Endocrinology, University of Naples Federico II

Inclusion Criteria:

  • Adult obese subjects

Exclusion Criteria:

  • Hypocaloric diet in the last three months or specific nutritional regimens, including vegan or vegetarian diets;
  • Presence of liver or renal failure, cancer, and acute or chronic inflammatory diseases based on a complete medical examination and laboratory investigations (psoriasis, rheumatoid arthritis and chronic obstructive pulmonary disease);
  • Occasional or current of use of drugs affecting β-oxidation, including non-steroidal anti-inflammatory drugs, α-lipoic acid, valproic acid
  • Use of weight loss medication or lipid-lowering drugs
  • Altered thyroid hormone function tests or thyroid hormone treatment or altered somatotropic axis
  • Alcohol abuse according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-V diagnostic criteria
  • Vitamin/mineral or antioxidant supplementation
  • Subjects dropped out from the study since they refused to undergo full laboratory-instrumental examinations.
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Responsible Party: Prof. Silvia Savastano, Researcher/Adjunct Professor, Federico II University Identifier: NCT02840981    
Other Study ID Numbers: 5/14
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: July 21, 2016
Last Verified: July 2016