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临床试验/NCT01215903
NCT01215903已完成2 期

The Beneficial Effects of Fish Nutrients on the Obesity-linked Metabolic Syndrome and Cardiovascular Risk Profile

Laval University2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2007年11月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
21
试验地点
2
主要终点
Plasma and serum inflammatory markers

研究概览

简要总结

The present study was conducted to test whether a fish gelatin supplement combined with an omega-3 polyunsaturated fatty acid supplement can exert beneficial and sex-specific effects on insulin sensitivity, glucose tolerance, indicators of insulin secretion, blood pressure, lipid metabolism, inflammation and energy intake in obese or overweight insulin-resistant men and women. The investigators hypothesis is that fish gelatin improves insulin sensitivity, glucose tolerance, lipid profile and reduces inflammation in obese or overweight insulin-resistant men and women.

详细描述

An important number of recent epidemiological studies have demonstrated the beneficial effects of marine omega-3 polyunsaturated fatty acids (n-3 PUFA) on cardiovascular disease risk factors such as reduced triglycerides, decreased platelet aggregation, plaque stabilization, antiarrhythmic effects, and reduced blood pressure. Dietary fish protein has also been shown to improve insulin sensitivity by 30% in insulin-resistant obese or overweight human subjects. In addition, an increasing number of studies describe and demonstrate the physiological and metabolic variations between men and women in regard to CVD and their risk factors, including type 2 diabetes, but the data are still limited. In agreement with the recent findings, this study was conducted to evaluate the combined and synergistic effects of omega-3 and fish protein supplements on insulin sensitivity, blood pressure, lipid metabolism and inflammation in obese or overweight insulin-resistant men and women having some or all the metabolic syndrome criteria including a deteriorated lipid profile, high blood pressure and high waist circumference in a free living situation.

研究设计

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

入排标准

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

入选标准

  • overweight or obese (body mass index [BMI] between 25 and 40kg/m2)
  • fasting plasma glucose below 7.0mmol/L and 2-h plasma glucose below 11.1mmol/L
  • fasting plasma insulin above 90pmol/L

排除标准

  • Diabetes, chronic, metabolic or acute disease
  • Major surgery within the last 3 months
  • Significant weight loss (±10%) within the last 6 months
  • Any medication-taking known to affect lipid of glucose metabolism
  • Allergy, intolerance or dislike of fish

结局指标

主要结局

Plasma and serum inflammatory markers

时间窗: At 8 weeks

Insulin sensitivity

时间窗: At 8 weeks

Plasma lipids and lipoproteins

时间窗: at 8 weeks

Blood pressure

时间窗: At 8 weeks

次要结局

  • Fatty acids of phospholipids in skeletal muscle(At 8 weeks)
  • Glucose tolerance(At 8 weeks)
  • Energy intake(At 8 weeks)

研究者

申办方类型
Other

研究点 (2)

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