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临床试验/NCT03182712
NCT03182712已完成不适用

Effects of n-3 Fatty Acids and Vitamin E Supplementation Upon Oxidative Stress, Inflammation and Metabolic Parameters in Type 2 Diabetic Subjects at Rest and After an Acute High Intensity Exercise Bout

Federal University of Rio Grande do Sul2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2007年2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
30
试验地点
2
主要终点
Changes on hs-CRP (High-sensitivity C reactive protein)

研究概览

简要总结

The aim of this study was to verify the effect of a combined supplementation [n-3 PUFA (known to induce anti-inflammatory effects) plus vitamin E (known for its antioxidant properties)] on lipidic, glycemic, redox status and inflammatory parameters in type 2 diabetic patients. In addition, considering that exercise, at high intensities, can induce a transient inflammatory state and increase oxidative stress (OS) markers, the investigators tested if our nutritional intervention could attenuate this response within this population (thus, using high intensity exercise as inductor of acute inflammatory/OS state).

详细描述

Herein the investigators tested the effect of eight weeks of omega-3 polyunsaturated fatty acid (n-3 PUFA) and vitamin E supplementation before and after an acute high intensity exercise bout on lipid profile, glycemic, redox and inflammatory parameters in type 2 diabetic (T2DM) patients. Thirty T2DM patients, without chronic complications, took part in this study. Blood and urine samples were collected after 12 h-fasting state for baseline biochemical analysis. Thereafter, subjects performed an incremental workload VO2max test on a cycle ergometer to determine the load of the high intensity submaximal exercise. On the following week, blood samples were collected before and immediately after the exercise test for measurements of oxidative stress (OS) and high-sensitivity C-reactive protein (hs-CRP). Afterwards, participants were randomly allocated into two groups: placebo (gelatin) and n-3 PUFA (capsules containing 180 mg of eicosapentaenoic acid, 120 mg of docosahexaenoic acid and 2 mg of vitamin E). Three capsules were ingested daily for eight weeks. Then, the examination protocol and the exercise test were repeated and the samples collected.

研究设计

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

入排标准

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

入选标准

  • Clinical diagnosis of Type 2 Diabetes
  • Male and female
  • Age between 40 and 60 years old.
  • Must be able to do exercise

排除标准

  • Clinical diagnosis of kidney, pulmonary or heart diseases

结局指标

主要结局

Changes on hs-CRP (High-sensitivity C reactive protein)

时间窗: Measured before the supplementation (baseline) and after eight weeks of supplementation

Marker of inflammation expressed in mg/dL

次要结局

  • Changes on F2-isoprostanes(Measured before the supplementation (baseline) and after eight weeks of supplementation)
  • Changes on Total Antioxidant activity(Measured before the supplementation (baseline) and after eight weeks of supplementation)
  • Changes on thiobarbituric acid reactivity(Measured before the supplementation (baseline) and after eight weeks of supplementation)

研究者

发起方
Federal University of Rio Grande do Sul
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maurício Krause

Professor

Federal University of Rio Grande do Sul

研究点 (2)

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