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临床试验/NCT01913756
NCT01913756已完成不适用

Dairy Products and Metabolic Syndrome

Norwegian University of Life Sciences2 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2013年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
153
试验地点
2
主要终点
Change in blood pressure

研究概览

简要总结

The purpose of this trial is to investigate the effect of dairy products on the so called metabolic syndrome. Metabolic syndrome is a cluster of risk factors, such as high blood pressure and high cholesterol, for the development of diabetes and heart disease. Participants will be randomly assigned to either eat a portion of a Norwegian traditional cheese which is high in protein and low in fat (group 1), or eat a slightly higher than normal intake of regular Gouda-type cheese (group 2), or to limit their intake of cheese (group 3).

Dairy products are a significant source of bioactive peptides, small pieces of protein which may have an effect on our health. These effects may be antimicrobial, antioxidative, or blood pressure lowering. The traditional Norwegian cheese, Gamalost, which is naturally high in protein (50%) and low in fat (<1%), has been found to be particularly high in these bioactive peptides. Specifically, the cheese was found to have a very high ACE-inhibitory activity, meaning it has the potential to lower blood pressure without the use of pharmaceuticals.

A pilot study was performed in May 2012. No intervention was given in this trial, but participants answered an extensive questionnaire about dietary habits and lifestyle. This trial found that the people who ate the most Gamalost had a slightly lower blood pressure than those that did not eat the cheese. Since that was just a point-in-time study with no intervention or control, the investigators are not able to say anything certain about cause and effect, which is why the investigators want to perform this larger controlled study.

In total, the investigators aim to recruit 300 people to participate in this trial, i.e. 100 in each group. The participants will be randomly placed in one of the groups and they will have to do the intervention for eight weeks. At inclusion, the investigators measure blood pressure, fasting blood glucose, weight, height, waist circumference, and the investigators draw a fasting blood sample to measure cholesterol. The same measurements will be repeated at the end of the eight weeks. At inclusion they will also fill out an extensive questionnaire about their diet and lifestyle. A shorter version of the same questionnaire will also be given at the end of the trial period.

The overall goal of the study is to assess the effect of dairy products on the metabolic syndrome, but the main hypothesis is to assess whether a high intake of Gamalost can reduce blood pressure in a group of people.

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 (Outcomes Assessor)

入排标准

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

入选标准

  • Healthy adults
  • Must be able to eat cheese evey day

排除标准

  • Pregnant women
  • Taking blood pressure lowering medication
  • Not able to read Norwegian

研究组 & 干预措施

Gouda-type cheese

Experimental

80 g/day Gouda-type cheese

干预措施: Gouda-type cheese (Dietary Supplement)

Low cheese intake

No Intervention

Gamalost (Norwegian traditional cheese)

Experimental

50 g/day Gamalost

干预措施: Gamalost (Norwegian traditional cheese) (Dietary Supplement)

结局指标

主要结局

Change in blood pressure

时间窗: Baseline, 4 weeks and 8 weeks.

次要结局

  • Change in serum cholesterol levels(Baseline and 8 weeks.)
  • Change in body composition.(Baseline and 8 weeks.)

研究者

发起方
Norwegian University of Life Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rita Nilsen

PhD Student

Norwegian University of Life Sciences

研究点 (2)

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