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临床试验/NCT02840981
NCT02840981已完成不适用

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

Federico II University0 个研究点目标入组 43 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
43
主要终点
Adherence to Mediterranean Diet by Predimed Questionnaire

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult obese subjects

排除标准

  • 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.

结局指标

主要结局

Adherence to Mediterranean Diet by Predimed Questionnaire

时间窗: December 2013 to September 2015

Circulating Levels of Sirtuin 4 by ELISA method

时间窗: December 2013 to September 2015

Obesity by Body Mass Index

时间窗: December 2013 to September 2015

次要结局

未报告次要终点

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Silvia Savastano

Researcher/Adjunct Professor

Federico II University

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