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临床试验/NCT01397942
NCT01397942已完成不适用

Maximising the Taste and Health Value of Plant Food Products - Impact on Vegetable Consumption, Consumer Preferences and Human Health Factors.

Aarhus University Hospital2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2011年5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
92
试验地点
2
主要终点
Insulin sensitivity

研究概览

简要总结

To investigate if a high dietary intake of bitter and strong tasting vegetables have positive health effects (insulin sensitivity, glucose tolerance, central obesity, fasting and postprandial lipid profile, blood pressure, vitamin D status and inflammatory markers, biomarkers of oxidative stress) on subjects with T2D. Also to look at a high dietary intake of mild and sweet modern vegetables or a normal western diet.

详细描述

The metabolic syndrome (MS), type 2 diabetes (T2D) and obesity are the world's most prevalent lifestyle diseases. This unfortunate development is mainly caused by lifestyle choices leading to obesity due to physical inactivity and excessive calorie intake.

Vegetables are an important part of the human diet and a major source of biologically active substances which determine the nutritional quality of food, color, taste, smell, antioxidative, anticarcinogenic, antihypertensive, anti-inflammatory, antihyperglycemia, immunostimulating and cholesterol-lowering properties.

Diet, as one aspect of lifestyle, is thought to be one of the modifiable variable risk factors for the development of MS and T2D, but more information is needed as to which components of the diet could be protective for the development and progression of MS and T2D with all its complications.

The study will be carried out as a 3-month randomized controlled parallel intervention study involving 60 subjects with T2D. During the fall year 2011 30 (10 in each group) subjects will participate and the remaining 30 subjects (10 in each group) in the fall 2012. The subjects will be randomized into 3 different diets:

  1. A) "A healthy Nordic diet" with high content of bitter strong tasting vegetables and cabbages.
  2. B) "A healthy Nordic diet" with high content of sweet and mild tasting vegetables and cabbages.
  3. C) A diet habitually consumed in the Nordic countries (normal control diet). The subjects in groups A and B will each have to consume 500 g root vegetables and cabbages daily which will be handed out once a week. The participants will visit the study clinic at screening, and then once weekly during the intervention period (12 weeks). Beside the screening examination there will be 3 major visits (0, 6 and 12 weeks) where the participants will collect urine samples, complete a 3-day weighed food diary (to control diet intake) and undergo clinical examination incl. measuring of blood pressure, body composition and collection of fasting blood samples i.e. glucose, insulin, glucagon, HbA1c, GLP-1, lipids (triglycerides, HDL-, LDL- and total cholesterol), cytokines, adipokines, parathyroid hormone and vitamin D. During first (week 0) and third (week 12) major visit a 120 minutes oral glucose tolerance test is included collecting blood to analyze for glucose, insulin and triglycerides.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes in diet treatment or on oral anti-diabetic drug or the metabolic syndrome.

排除标准

  • Other severe diseases or in treatment with insulin, GLP-1 analogs, glitazones.

结局指标

主要结局

Insulin sensitivity

时间窗: 2 years

Measured as the AUC from an Oral Glucose Tolerance Test

次要结局

  • Urine and blood samples(2 years)

研究者

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

Per Bendix Jeppesen

Associate prof., PhD

Aarhus University Hospital

研究点 (2)

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