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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

Tracking Information
First Submitted Date  ICMJE June 22, 2016
First Posted Date  ICMJE July 19, 2016
Last Update Posted Date May 17, 2017
Actual Study Start Date  ICMJE May 4, 2017
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02837666 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2016)
  • 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)
  • General fitness assessed by change in heart rate [ Time Frame: 14 weeks ]
    Change in heart rate by using a pulsometer (Polar HT7)
  • General fitness assessed by change in lactate [ Time Frame: 14 weeks ]
    Change in lactate concentration by using an automatized method (YSI lactate analyzer-1600)
  • 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)
  • General fitness assessed by change in blood pressure [ Time Frame: 14 weeks ]
    Change in blood pressure by using an aneroid sphygmomanometer (Edimetric, Medical Technologies)
  • Redox status assessed by change in malondialdehyde [ Time Frame: 14 weeks ]
    Change in malondialdehyde concentration by using standardized specific methods
  • Redox status assessed by change in protein carbonyls [ Time Frame: 14 weeks ]
    Change in protein carbonyls concentration by using standardized specific methods
  • Redox status assessed by change in paraoxonase [ Time Frame: 14 weeks ]
    Change in paraoxonase concentration by using standardized specific methods
  • Redox status assessed by change in superoxide dismutase [ Time Frame: 14 weeks ]
    Change in superoxide dismutase concentration by using standardized specific methods
  • Redox status assessed by change in catalase [ Time Frame: 14 weeks ]
    Change in catalase concentration by using standardized specific methods
  • Redox status assessed by change in glutathione [ Time Frame: 14 weeks ]
    Change in glutathione concentration by using standardized specific methods
  • Redox status assessed by change in glutathione reductase [ Time Frame: 14 weeks ]
    Change in glutathione reductase concentration by using standardized specific methods
  • Redox status assessed by change in glutathione peroxidase [ Time Frame: 14 weeks ]
    Change in glutathione peroxidase concentration by using standardized specific methods
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hypolipidemic and Antioxidant Capacity of Spirulina and Exercise
Official Title  ICMJE Independent and Synergistic Effect of Spirulina Maxima With Exercise on General Fitness, Lipid Profile and Antioxidant Capacity in Overweight and Obese Subjects
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cardiovascular Diseases
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Dietary Supplement: Supplementation with Spirulina maxima
    • Other: Washout
    • Other: Supplementation with placebo
    • Other: Isoenergetic diet
    • Other: Exercise program
  • 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.
    Interventions:
    • Dietary Supplement: Supplementation with Spirulina maxima
    • Other: Washout
    • Other: Supplementation with placebo
    • Other: Isoenergetic diet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 15, 2016)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02837666
Other Study ID Numbers  ICMJE UACJ-ICB-2016-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Will be published in index journals
Responsible Party Universidad Autonoma de Ciudad Juarez
Study Sponsor  ICMJE Universidad Autonoma de Ciudad Juarez
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marco A Hernandez-Lepe, MS Universidad Autonoma de Ciudad Juarez
Study Director: Arnulfo Ramos-Jimenez, phD Universidad Autonoma de Ciudad Juarez
PRS Account Universidad Autonoma de Ciudad Juarez
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP