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Completed

NCT Number: NCT02837666

Hypolipidemic and Antioxidant Capacity of Spirulina and Exercise

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.

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Key information

Conditions

Cardiovascular Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Autonoma de Ciudad Juarez

Juárez, Chihuahua, 32310, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Supplementation with Spirulina maxima

Dietary Supplement

Supplementation with Spirulina maxima (4.5 g/d) in capsules during 6 weeks.

Washout

Other

2 weeks washout period to each study subject to avoid any possible carryover effect.

Supplementation with placebo

Other

Supplementation with placebo (4.5 g/d) in capsules during 6 weeks.

Isoenergetic diet

Other

All participants will have a personal isoenergetic diet according to their height, weight, body composition and daily physical activity during 14 weeks

exercise program

Other

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.

Primary outcomes

  1. Change in lipid profile

    Time frame: 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

Secondary outcomes

  1. General fitness assessed by change in maximum oxygen consumption

    Time frame: 14 weeks

    Change in maximum oxygen consumption by using a gas analyzer (Cortex Metalizer 3B)

  2. General fitness assessed by change in heart rate

    Time frame: 14 weeks

    Change in heart rate by using a pulsometer (Polar HT7)

  3. General fitness assessed by change in lactate

    Time frame: 14 weeks

    Change in lactate concentration by using an automatized method (YSI lactate analyzer-1600)

  4. General fitness assessed by change in body mass

    Time frame: 14 weeks

    Change in body fat mass and body lean mass by using pletysmography (BOD-POD)

  5. General fitness assessed by change in blood pressure

    Time frame: 14 weeks

    Change in blood pressure by using an aneroid sphygmomanometer (Edimetric, Medical Technologies)

  6. Redox status assessed by change in malondialdehyde

    Time frame: 14 weeks

    Change in malondialdehyde concentration by using standardized specific methods

  7. Redox status assessed by change in protein carbonyls

    Time frame: 14 weeks

    Change in protein carbonyls concentration by using standardized specific methods

  8. Redox status assessed by change in paraoxonase

    Time frame: 14 weeks

    Change in paraoxonase concentration by using standardized specific methods

  9. Redox status assessed by change in superoxide dismutase

    Time frame: 14 weeks

    Change in superoxide dismutase concentration by using standardized specific methods

  10. Redox status assessed by change in catalase

    Time frame: 14 weeks

    Change in catalase concentration by using standardized specific methods

  11. Redox status assessed by change in glutathione

    Time frame: 14 weeks

    Change in glutathione concentration by using standardized specific methods

  12. Redox status assessed by change in glutathione reductase

    Time frame: 14 weeks

    Change in glutathione reductase concentration by using standardized specific methods

  13. Redox status assessed by change in glutathione peroxidase

    Time frame: 14 weeks

    Change in glutathione peroxidase concentration by using standardized specific methods

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Ciudad Juarez

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 19, 2016
Registry last updated
Nov 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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