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Hypolipidemic and Antioxidant Capacity of Spirulina and Exercise

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ClinicalTrials.gov Identifier: NCT02837666
Recruitment Status : Unknown
Verified March 2017 by Universidad Autonoma de Ciudad Juarez.
Recruitment status was:  Recruiting
First Posted : July 19, 2016
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Dietary Supplement: Supplementation with Spirulina maxima Other: Washout Other: Supplementation with placebo Other: Isoenergetic diet Other: Exercise program Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Independent and Synergistic Effect of Spirulina Maxima With Exercise on General Fitness, Lipid Profile and Antioxidant Capacity in Overweight and Obese Subjects
Actual Study Start Date : May 4, 2017
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
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.

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

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

Other: 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.

Active Comparator: 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.
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.

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837666


Contacts
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Contact: Arnulfo Ramos-Jimenez, phD 6561679309 aramos@uacj.mx
Contact: Marco A Hernandez-Lepe, MS 6562159803 qblepe@hotmail.com

Locations
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Mexico
Universidad Autonoma de Ciudad Juarez Recruiting
Juarez, Chihuahua, Mexico, 32310
Contact: Barraza Patricia, Dra    526566881888 ext 1889    mbarraza@uacj.mx   
Contact: Amaelvi Arce, Lic    526566881888 ext 1589    aarce@uacj.mx   
Principal Investigator: Veronica Portillo, MA         
Sub-Investigator: Miguel Perez, PhD         
Sub-Investigator: Yolanda Loya, PhD         
Sponsors and Collaborators
Universidad Autonoma de Ciudad Juarez
Investigators
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Principal Investigator: Marco A Hernandez-Lepe, MS Universidad Autonoma de Ciudad Juarez
Study Director: Arnulfo Ramos-Jimenez, phD Universidad Autonoma de Ciudad Juarez

Additional Information:
Publications:
Pescatello, Linda S., American College of Sports Medicine. Acsms Guidelines for Exercise Testing and Prescription. Wolters Kluwer/Lippincott Williams & Wilkins Health; Edición: 9th revised North American ed. 2014. 480 p
Montoya, C. G., Ospina, C. O., Mesa, N. S., Cano, C. M., Lobo, M., Arias, P. G. G., & Pérez, B. R. Actividad antioxidante e inhibición de la peroxidación lipídica de extractos de frutos de mortiño (Vaccinium meridionale SW). Boletín Latinoamericano y del Caribe de Plantas Medicinales y Aromáticas, 2009; 8 (6): 519-528.
Alvarez-Parrilla, E., de la Rosa, L.A., Torres-Rivas, F., Rodrigo-Garcia, J., González-Aguilar, G. Complexation of apple antioxidants: chlorogenic acid, quercetin and rutin by β-cyclodextrin (β-CD). Journal of inclusion phenomena and macrocyclic chemistry, 2005; 53 (1-2): 121-129.
Anitha, L., Chandralekha, K. Effect of supplementation of spirulina on blood glucose, glycosylated hemoglobin and lipid profile of male non-insulin dependent diabetics. Asian J Exp Biol Sci; 2010; 1: 36-46.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universidad Autonoma de Ciudad Juarez
ClinicalTrials.gov Identifier: NCT02837666     History of Changes
Other Study ID Numbers: UACJ-ICB-2016-01
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Will be published in index journals

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs