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临床试验/NCT02837666
NCT02837666已完成不适用

Independent and Synergistic Effect of Spirulina Maxima With Exercise on General Fitness, Lipid Profile and Antioxidant Capacity in Overweight and Obese Subjects

Universidad Autonoma de Ciudad Juarez2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2017年5月4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
52
试验地点
2
主要终点
Change in lipid profile

研究概览

简要总结

The purpose of this study is to demonstrate that Spirulina maxima intake and a dosed physical activity program will decrease, both independently and synergistically, cardiovascular risks (Dyslipidemias and oxidative stress) in overweight and obese subjects.

详细描述

Cardiovascular diseases are the leading cause of death globally, being dyslipidemias, oxidative stress, sedentary lifestyle and obesity primary risk factors. As a way to reduce cardiovascular diseases risk factors, the intake of antioxidants that come from a fruit and vegetable-rich diet or nutritional supplements, have been proposed; in this sense, the cyanobacterium Spirulina maxima is an important source of antioxidants, which is currently associated with cardiovascular protection properties. Furthermore, physical exercise at moderated intensity has protective effect exerted against cardiovascular diseases risks, mainly due to physiological adaptations, including expression of antioxidant enzymes, which stop formation and propagation of radicals, improving redox status of the organism.

There is evidence that Spirulina maxima, in addition to exercise, decreases cardiovascular diseases risks, this was mainly observed in animal models. However, no studies in humans under Spirulina maxima and exercise experimental designs proving these benefits are reported. Therefore this study will analyze the independent and synergistic effect of the intake of Spirulina maxima with a program of physical exercise at moderated intensity on general fitness, plasma lipid profile and antioxidant capacity in overweight and obese subjects.

Methods/design: Through a randomized, double blind, placebo controlled, counterbalanced crossover study design, 80 healthy overweight and obese subjects will be assessed during a 12 week isoenergetic diet, accompanied by 4.5 g/day Spirulina maxima intake and/or a systematic physical exercise program at moderate intensity. Body composition, VO2 consumption, heart rate, blood lactate, plasma concentrations of triacylglycerols, total, low and high-density lipoprotein cholesterol, antioxidant status, lipid oxidation, protein carbonyls, superoxide dismutase, catalase, glutathione, glutathione peroxidase, glutathione reductase, and paraoxonase will be assessed.

Discussion: Spirulina maxima and exercise are good alternatives to improve general fitness, to prevent or lessen dyslipidemia and oxidative stress in subjects with risk factor of chronic or noncommunicable diseases. However the independent and synergistic effect of Spirulina maxima with exercise against dyslipidemias and stress in overweight and obesity is not yet known.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Overweight (Body mass index (BMI): 25-29.9 kg/m2) and obese (BMI: > 30 kg/m2) persons

排除标准

  • Taking drugs and/or food or vitamin supplements
  • have a physical or electrocardiographic injury that prevents them from engaging in regular physical exercise

结局指标

主要结局

Change in lipid profile

时间窗: 14 weeks

Change in plasma triacylglycerols, total cholesterol, high density lipoproteins cholesterol, and low density lipoproteins cholesterol after each treatment by using standardized enzymatic methods

次要结局

  • General fitness assessed by change in maximum oxygen consumption(14 weeks)
  • General fitness assessed by change in body mass(14 weeks)
  • General fitness assessed by change in heart rate(14 weeks)
  • General fitness assessed by change in lactate(14 weeks)
  • General fitness assessed by change in blood pressure(14 weeks)
  • Redox status assessed by change in malondialdehyde(14 weeks)
  • Redox status assessed by change in glutathione(14 weeks)
  • Redox status assessed by change in glutathione reductase(14 weeks)
  • Redox status assessed by change in protein carbonyls(14 weeks)
  • Redox status assessed by change in paraoxonase(14 weeks)
  • Redox status assessed by change in superoxide dismutase(14 weeks)
  • Redox status assessed by change in catalase(14 weeks)
  • Redox status assessed by change in glutathione peroxidase(14 weeks)

研究者

发起方
Universidad Autonoma de Ciudad Juarez
申办方类型
Other
责任方
Sponsor

研究点 (2)

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