Hypolipidemic and Antioxidant Capacity of Spirulina and Exercise

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02837666
• Other study ID #: UACJ-ICB-2016-01
• Status: Completed
• Phase: N/A
• Start date: May 4, 2017
• Est. completion date: December 10, 2017

Study information

• Verified date: October 2019
• Source: Universidad Autonoma de Ciudad Juarez
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 10, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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

Other:
• 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.

Locations

Country	Name	City	State
Mexico	Universidad Autonoma de Ciudad Juarez	Juarez	Chihuahua

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Ciudad Juarez

Country where clinical trial is conducted

Mexico, 

References & Publications (39)

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in lipid profile	Change in plasma triacylglycerols, total cholesterol, high density lipoproteins cholesterol, and low density lipoproteins cholesterol after each treatment by using standardized enzymatic methods	14 weeks
Secondary	General fitness assessed by change in maximum oxygen consumption	Change in maximum oxygen consumption by using a gas analyzer (Cortex Metalizer 3B)	14 weeks
Secondary	General fitness assessed by change in heart rate	Change in heart rate by using a pulsometer (Polar HT7)	14 weeks
Secondary	General fitness assessed by change in lactate	Change in lactate concentration by using an automatized method (YSI lactate analyzer-1600)	14 weeks
Secondary	General fitness assessed by change in body mass	Change in body fat mass and body lean mass by using pletysmography (BOD-POD)	14 weeks
Secondary	General fitness assessed by change in blood pressure	Change in blood pressure by using an aneroid sphygmomanometer (Edimetric, Medical Technologies)	14 weeks
Secondary	Redox status assessed by change in malondialdehyde	Change in malondialdehyde concentration by using standardized specific methods	14 weeks
Secondary	Redox status assessed by change in protein carbonyls	Change in protein carbonyls concentration by using standardized specific methods	14 weeks
Secondary	Redox status assessed by change in paraoxonase	Change in paraoxonase concentration by using standardized specific methods	14 weeks
Secondary	Redox status assessed by change in superoxide dismutase	Change in superoxide dismutase concentration by using standardized specific methods	14 weeks
Secondary	Redox status assessed by change in catalase	Change in catalase concentration by using standardized specific methods	14 weeks
Secondary	Redox status assessed by change in glutathione	Change in glutathione concentration by using standardized specific methods	14 weeks
Secondary	Redox status assessed by change in glutathione reductase	Change in glutathione reductase concentration by using standardized specific methods	14 weeks
Secondary	Redox status assessed by change in glutathione peroxidase	Change in glutathione peroxidase concentration by using standardized specific methods	14 weeks

External Links

•   Statistics World Health Organization (WHO)