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Double-blind randomised controlled trial of the independent and synergistic effect of Spirulina maxima with exercise (ISESE) on general fitness, lipid profile and redox status in overweight and obese subjects: study protocol
  1. Marco Antonio Hernández-Lepe1,
  2. José Alberto López-Díaz2,
  3. Laura Alejandra de la Rosa2,
  4. Rosa Patricia Hernández-Torres3,
  5. Abraham Wall-Medrano2,
  6. Marco Antonio Juarez-Oropeza4,
  7. José Pedraza-Chaverri5,
  8. Rene Urquidez-Romero2,
  9. Arnulfo Ramos-Jiménez2
  1. 1 Departamento de Ciencias Químico Biológicas, Instituto de Ciencias Biomédicas, Universidad Autónoma de Ciudad Juárez, Ciudad Juárez, Chihuahua, México
  2. 2 Departamento de Ciencias de la Salud, Instituto de Ciencias Biomédicas, Universidad Autónoma de Ciudad Juárez, Ciudad Juárez, Chihuahua, México
  3. 3 Departamento de Bioquímica, Facultad de Medicina, Universidad Nacional Autónoma de México, Ciudad de México, México
  4. 4 Facultad de Ciencias de la Cultura Física, Universidad Autónoma de Chihuahua, Chihuahua, México
  5. 5 Departamento de Biología, Facultad de Química, Universidad Nacional Autónoma de México, Ciudad de México, México
  1. Correspondence to Dr Arnulfo Ramos-Jiménez; aramos{at}uacj.mx

Abstract

Introduction In order to reduce cardiovascular disease risk factors, a healthy diet must include dietary antioxidants from different sources (eg, Spirulina maxima) and regular practice of exercise should be promoted. There is some evidence from animal studies that S. maxima and exercise decrease cardiovascular disease risks factors. However, very few studies have proved the independent or synergistic effect of S. maxima plus exercise in humans. This study attempts to address the independent and synergistic effects in overweight and obese subjects participating in a systematic physical exercise programme at moderate intensity on general fitness, plasma lipid profile and antioxidant capacity.

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

Ethics and dissemination This study and all the procedures have been approved by the Universidad Autonoma de Ciudad Juarez Bioethics Committee. Findings will be disseminated through peer-reviewed journals, national and international conferences.

Trial registration number ClinicalTrials.gov: NCT02837666.

  • spirulina
  • dyslipidemias
  • oxidative stress
  • exercise
  • body fat
  • antioxidant

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors All authors contributed to the development of the study protocol and to the critical revision of the paper and approved the final version. RPHT, ARJ and JALD will be involved in patient recruitment; MAHL and AWM will analyse the data; MAHL and MAJO will do the lipid profile analyses; RUR, ARJ and MAHL will do the body composition measurements of all patients; LARC and JPC will do all the redox status analyses.

  • Competing interests None declared.

  • Patient consent Obtained.

  • Ethics approval Universidad Autonoma de Ciudad Juarez Bioethics Committee.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement The protocol is an unpublished manuscript and is not under consideration by any other journal.

  • Correction notice This paper has been amended since it was published Online First. Owing to a scripting error, some of the publisher names in the references were replaced with 'BMJ Publishing Group'. This only affected the full text version, not the PDF. We have since corrected these errors and the correct publishers have been inserted into the references.