Hypolipidemic and Antioxidant Capacity of Spirulina and Exercise
- Conditions
- Cardiovascular Diseases
- Interventions
- Dietary Supplement: Supplementation with Spirulina maximaOther: WashoutOther: Supplementation with placeboOther: Isoenergetic dietOther: Exercise program
- Registration Number
- NCT02837666
- Lead Sponsor
- Universidad Autonoma de Ciudad Juarez
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- Overweight (Body mass index (BMI): 25-29.9 kg/m2) and obese (BMI: > 30 kg/m2) persons
- Taking drugs and/or food or vitamin supplements
- diabetes
- have a physical or electrocardiographic injury that prevents them from engaging in regular physical exercise
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description No exercise group and supplementation Supplementation with placebo 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. Exercise group and supplementation Supplementation with placebo 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. Exercise group and supplementation Exercise program 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. Exercise group and supplementation Supplementation with Spirulina maxima 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. Exercise group and supplementation Washout 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. Exercise group and supplementation Isoenergetic diet 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. No exercise group and supplementation Supplementation with Spirulina maxima 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. No exercise group and supplementation Washout 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. No exercise group and supplementation Isoenergetic diet 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.
- Primary Outcome Measures
Name Time Method Change in lipid profile 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 Outcome Measures
Name Time Method Redox status assessed by change in glutathione 14 weeks Change in glutathione concentration by using standardized specific methods
Redox status assessed by change in glutathione reductase 14 weeks Change in glutathione reductase concentration by using standardized specific methods
General fitness assessed by change in maximum oxygen consumption 14 weeks Change in maximum oxygen consumption by using a gas analyzer (Cortex Metalizer 3B)
General fitness assessed by change in body mass 14 weeks Change in body fat mass and body lean mass by using pletysmography (BOD-POD)
General fitness assessed by change in heart rate 14 weeks Change in heart rate by using a pulsometer (Polar HT7)
General fitness assessed by change in lactate 14 weeks Change in lactate concentration by using an automatized method (YSI lactate analyzer-1600)
General fitness assessed by change in blood pressure 14 weeks Change in blood pressure by using an aneroid sphygmomanometer (Edimetric, Medical Technologies)
Redox status assessed by change in malondialdehyde 14 weeks Change in malondialdehyde concentration by using standardized specific methods
Redox status assessed by change in protein carbonyls 14 weeks Change in protein carbonyls concentration by using standardized specific methods
Redox status assessed by change in paraoxonase 14 weeks Change in paraoxonase concentration by using standardized specific methods
Redox status assessed by change in superoxide dismutase 14 weeks Change in superoxide dismutase concentration by using standardized specific methods
Redox status assessed by change in catalase 14 weeks Change in catalase concentration by using standardized specific methods
Redox status assessed by change in glutathione peroxidase 14 weeks Change in glutathione peroxidase concentration by using standardized specific methods
Trial Locations
- Locations (1)
Universidad Autonoma de Ciudad Juarez
🇲🇽Juarez, Chihuahua, Mexico