Hypolipidemic and Antioxidant Capacity of Spirulina and Exercise
NCT ID: NCT02837666
Last Updated: 2019-11-13
Study Results
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Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2017-05-04
2017-12-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Exercise group and supplementation
Supplementation with Spirulina maxima Supplementation with placebo Group with exercise program and supplementation with Spirulina maxima or placebo (4.5 g/d) in capsules during 6 weeks, then a 2 weeks washout, to finally proceed to the other treatment during 6 more weeks. During the 14 weeks of study duration every participant will have a personal isoenergetic diet.
Supplementation with Spirulina maxima
Supplementation with Spirulina maxima (4.5 g/d) in capsules during 6 weeks.
Washout
2 weeks washout period to each study subject to avoid any possible carryover effect.
Supplementation with placebo
Supplementation with placebo (4.5 g/d) in capsules during 6 weeks.
Isoenergetic diet
All participants will have a personal isoenergetic diet according to their height, weight, body composition and daily physical activity during 14 weeks
Exercise program
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.
No exercise group and supplementation
Supplementation with Spirulina maxima Supplementation with placebo Group without exercise program and supplementation with Spirulina maxima or placebo (4.5 g/d) in capsules during 6 weeks, then a 2 weeks washout, to finally proceed to the other treatment during 6 more weeks. During the 14 weeks of study duration every participant will have a personal isoenergetic diet.
Supplementation with Spirulina maxima
Supplementation with Spirulina maxima (4.5 g/d) in capsules during 6 weeks.
Washout
2 weeks washout period to each study subject to avoid any possible carryover effect.
Supplementation with placebo
Supplementation with placebo (4.5 g/d) in capsules during 6 weeks.
Isoenergetic diet
All participants will have a personal isoenergetic diet according to their height, weight, body composition and daily physical activity during 14 weeks
Interventions
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Supplementation with Spirulina maxima
Supplementation with Spirulina maxima (4.5 g/d) in capsules during 6 weeks.
Washout
2 weeks washout period to each study subject to avoid any possible carryover effect.
Supplementation with placebo
Supplementation with placebo (4.5 g/d) in capsules during 6 weeks.
Isoenergetic diet
All participants will have a personal isoenergetic diet according to their height, weight, body composition and daily physical activity during 14 weeks
Exercise program
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* diabetes
* have a physical or electrocardiographic injury that prevents them from engaging in regular physical exercise
18 Years
35 Years
ALL
Yes
Sponsors
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Universidad Autonoma de Ciudad Juarez
OTHER
Responsible Party
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Principal Investigators
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Marco A Hernandez-Lepe, MS
Role: PRINCIPAL_INVESTIGATOR
Universidad Autonoma de Ciudad Juarez
Arnulfo Ramos-Jimenez, phD
Role: STUDY_DIRECTOR
Universidad Autonoma de Ciudad Juarez
Locations
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Universidad Autonoma de Ciudad Juarez
Juárez, Chihuahua, Mexico
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Statistics World Health Organization (WHO)
Other Identifiers
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UACJ-ICB-2016-01
Identifier Type: -
Identifier Source: org_study_id
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