Hypolipidemic and Antioxidant Capacity of Spirulina and Exercise
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Supplementation with Spirulina maxima; Washout; Supplementation with placebo; Isoenergetic diet; Exercise program
Intervention type(s): Dietary Supplement; Other; Other; Other; Other
Intervention description(s): Supplementation with Spirulina maxima (4.5 g/d) in capsules during 6 weeks.; 2 weeks washout period to each study subject to avoid any possible carryover effect.; Supplementation with placebo (4.5 g/d) in capsules during 6 weeks.; All participants will have a personal isoenergetic diet according to their height, weight, body composition and daily physical activity during 14 weeks; Participants are going to exercise five days a week with the following protocol: Between 5 and 10 min of heating exercise, Between 20-30 min anaerobic exercise and 20-30 min of aerobic exercise (cardiovascular exercise): walking, jogging, running and/or cycling, Three days a week aerobic intensities will be between 60% and 80% and two days between 70% and 90% of the maximum heart rate reserve, and five final minutes of stretching.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment