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Hypolipidemic and Antioxidant Capacity of Spirulina and Exercise

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02837666
Enrollment
52
Registered
2016-07-19
Start date
2017-05-04
Completion date
2017-12-10
Last updated
2019-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Brief 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.

Interventions

DIETARY_SUPPLEMENTSupplementation with Spirulina maxima

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

OTHERWashout

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

OTHERExercise 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.

Sponsors

Universidad Autonoma de Ciudad Juarez
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in lipid profile14 weeksChange in plasma triacylglycerols, total cholesterol, high density lipoproteins cholesterol, and low density lipoproteins cholesterol after each treatment by using standardized enzymatic methods

Secondary

MeasureTime frameDescription
General fitness assessed by change in heart rate14 weeksChange in heart rate by using a pulsometer (Polar HT7)
General fitness assessed by change in lactate14 weeksChange in lactate concentration by using an automatized method (YSI lactate analyzer-1600)
General fitness assessed by change in body mass14 weeksChange in body fat mass and body lean mass by using pletysmography (BOD-POD)
General fitness assessed by change in blood pressure14 weeksChange in blood pressure by using an aneroid sphygmomanometer (Edimetric, Medical Technologies)
Redox status assessed by change in malondialdehyde14 weeksChange in malondialdehyde concentration by using standardized specific methods
Redox status assessed by change in protein carbonyls14 weeksChange in protein carbonyls concentration by using standardized specific methods
General fitness assessed by change in maximum oxygen consumption14 weeksChange in maximum oxygen consumption by using a gas analyzer (Cortex Metalizer 3B)
Redox status assessed by change in superoxide dismutase14 weeksChange in superoxide dismutase concentration by using standardized specific methods
Redox status assessed by change in catalase14 weeksChange in catalase concentration by using standardized specific methods
Redox status assessed by change in glutathione14 weeksChange in glutathione concentration by using standardized specific methods
Redox status assessed by change in glutathione reductase14 weeksChange in glutathione reductase concentration by using standardized specific methods
Redox status assessed by change in glutathione peroxidase14 weeksChange in glutathione peroxidase concentration by using standardized specific methods
Redox status assessed by change in paraoxonase14 weeksChange in paraoxonase concentration by using standardized specific methods

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026