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

July 20, 2016 updated by: Prof. Silvia Savastano, Federico II University

Obese Patients Adhering to Mediterranean Diet Show Less Reduced Circulating Levels of Sirtuin 4

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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

43

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adherence to Mediterranean Diet by Predimed Questionnaire
Time Frame: December 2013 to September 2015
December 2013 to September 2015
Circulating Levels of Sirtuin 4 by ELISA method
Time Frame: December 2013 to September 2015
December 2013 to September 2015
Obesity by Body Mass Index
Time Frame: December 2013 to September 2015
December 2013 to September 2015

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

July 20, 2016

First Posted (Estimate)

July 21, 2016

Study Record Updates

Last Update Posted (Estimate)

July 21, 2016

Last Update Submitted That Met QC Criteria

July 20, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 5/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

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