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Hypolipidemic and Antioxidant Capacity of Spirulina and Exercise

Sponsor
Universidad Autonoma de Ciudad Juarez (Other)
Overall Status
Completed
CT.gov ID
NCT02837666
Collaborator
(none)
52
Enrollment
1
Location
2
Arms
7.2
Actual Duration (Months)
7.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Dietary Supplement: Supplementation with Spirulina maxima
  • Other: Washout
  • Other: Supplementation with placebo
  • Other: Isoenergetic diet
  • Other: Exercise program
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
52 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
Actual Primary Completion Date :
Sep 30, 2017
Actual Study Completion Date :
Dec 10, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. General fitness assessed by change in maximum oxygen consumption [14 weeks]

    Change in maximum oxygen consumption by using a gas analyzer (Cortex Metalizer 3B)

  2. General fitness assessed by change in heart rate [14 weeks]

    Change in heart rate by using a pulsometer (Polar HT7)

  3. General fitness assessed by change in lactate [14 weeks]

    Change in lactate concentration by using an automatized method (YSI lactate analyzer-1600)

  4. General fitness assessed by change in body mass [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 [14 weeks]

    Change in blood pressure by using an aneroid sphygmomanometer (Edimetric, Medical Technologies)

  6. Redox status assessed by change in malondialdehyde [14 weeks]

    Change in malondialdehyde concentration by using standardized specific methods

  7. Redox status assessed by change in protein carbonyls [14 weeks]

    Change in protein carbonyls concentration by using standardized specific methods

  8. Redox status assessed by change in paraoxonase [14 weeks]

    Change in paraoxonase concentration by using standardized specific methods

  9. Redox status assessed by change in superoxide dismutase [14 weeks]

    Change in superoxide dismutase concentration by using standardized specific methods

  10. Redox status assessed by change in catalase [14 weeks]

    Change in catalase concentration by using standardized specific methods

  11. Redox status assessed by change in glutathione [14 weeks]

    Change in glutathione concentration by using standardized specific methods

  12. Redox status assessed by change in glutathione reductase [14 weeks]

    Change in glutathione reductase concentration by using standardized specific methods

  13. Redox status assessed by change in glutathione peroxidase [14 weeks]

    Change in glutathione peroxidase concentration by using standardized specific methods

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universidad Autonoma de Ciudad Juarez Juarez Chihuahua Mexico 32310

Sponsors and Collaborators

  • Universidad Autonoma de Ciudad Juarez

Investigators

  • Principal Investigator: Marco A Hernandez-Lepe, MS, Universidad Autonoma de Ciudad Juarez
  • Study Director: Arnulfo Ramos-Jimenez, phD, Universidad Autonoma de Ciudad Juarez

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Responsible Party:
Universidad Autonoma de Ciudad Juarez
ClinicalTrials.gov Identifier:
NCT02837666
Other Study ID Numbers:
  • UACJ-ICB-2016-01
First Posted:
Jul 19, 2016
Last Update Posted:
Nov 13, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cardiovascular Diseases

Study Results

No Results Posted as of Nov 13, 2019