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临床试验/NCT02356952
NCT02356952已完成不适用

A Low Glycemic Index Mediterranean Diet in the Treatment of Metabolic Syndrome. A Randomized Controlled Trial.

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis1 个研究点 分布在 1 个国家目标入组 163 人开始时间: 2014年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
163
试验地点
1
主要终点
Change from Baseline in MetS score at six months

研究概览

简要总结

Metabolic Syndrome (MetS) is a cluster of multiple risk factors of metabolic origin associated with an increased risk of cardiovascular disease, type 2 diabetes mellitus and other diseases, including some cancers. There has been an increased interest of researchers in the relationship between MetS and diet and, specifically, Mediterranean diet would be beneficial for people with high risk of developing MetS or individuals with established MetS.

详细描述

Metabolic Syndrome (MetS) is a cluster of multiple risk factors of metabolic origin, associated with an increased risk of cardiovascular disease, type 2 diabetes mellitus and other diseases, including some cancers. The National Cholesterol Education Program's Adult Treatment Panel III (NCEP-ATP III) defines MetS the presence of at least three of five diagnostic criteria consisting in the measure of waist circumference, fasting glucose, systolic pressure and/or diastolic blood pressure, serum triglycerides and HDL cholesterol. The level of physical activity, smoking habits, low social class membership as well as low level of education and even a mild degree of chronic inflammation have been associated with an increased risk of MetS. Recently, there has been an increased interest of researchers in the relationship between MetS and diet, and more specifically Mediterranean Diet (MD). A problem of the contemporary MD is the quality of carbohydrates as the foods rich in carbohydrates consumed actually, such as white bread and some type of pasta, are produced with refined flour, at high glycemic index (GI) and load (GL). There are numerous studies showing that taking large amounts of high GI and GL foods is a risk factor for coronary heart disease and type 2 diabetes. To our knowledge there is no diet trial that compared the health effects of Mediterranean diets with different quality of carbohydrates. Objective of this study was to compare, in a randomized clinical trial, the effects of a simple MD, a Low Glycemic Index diet (LGID), and a Low Glycemic Index MD (LGIMD) on MetS, MetS components and other metabolic variables. For this reason, after a baseline examination, participants were randomly divided into three groups, each receiving a specific dietary intervention, and all the parameters measured at the first visit were examined again at months third and sixth.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • MetS, Subject enrolled in the MICOL study in 2005-2006

排除标准

  • Insulin treatment, Not enrolled in the MICOL study

结局指标

主要结局

Change from Baseline in MetS score at six months

时间窗: 6 months

次要结局

  • Change from Baseline in Serum Cholesterol at six months(6 months)
  • Change from Baseline in Serum Triglycerides at six months(6 months)
  • Change from Baseline in Serum ALT at six months(6 months)
  • Change from Baseline in Serum Fasting Glucose at six months(6 months)
  • Change from Baseline in Serum insulin at six months(6 months)
  • Change from Baseline in Serum glycated hemoglobin at six months(6 months)
  • Change from Baseline in Serum HDL Cholesterol at six months(6 months)
  • Change from Baseline in Body Weight at six months(6 months)
  • Change from Baseline in Systolic blood pressure at six months(6 months)
  • Change from Baseline in Diastolic blood pressure at six months(6 months)
  • Height(Baseline)
  • Change from Baseline in Bioimpedenziometry at six months(6 months)

研究者

发起方
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alberto R Osella

MD, PhD

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

研究点 (1)

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