Hypolipidemic and Antioxidant Capacity of Spirulina and Exercise

November 12, 2019 updated by: Universidad Autonoma de Ciudad Juarez

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Chihuahua
      • Juarez, Chihuahua, Mexico, 32310
        • Universidad Autonoma de Ciudad Juarez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
14 weeks
General fitness assessed by change in heart rate
Time Frame: 14 weeks
Change in heart rate by using a pulsometer (Polar HT7)
14 weeks
General fitness assessed by change in lactate
Time Frame: 14 weeks
Change in lactate concentration by using an automatized method (YSI lactate analyzer-1600)
14 weeks
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)
14 weeks
General fitness assessed by change in blood pressure
Time Frame: 14 weeks
Change in blood pressure by using an aneroid sphygmomanometer (Edimetric, Medical Technologies)
14 weeks
Redox status assessed by change in malondialdehyde
Time Frame: 14 weeks
Change in malondialdehyde concentration by using standardized specific methods
14 weeks
Redox status assessed by change in protein carbonyls
Time Frame: 14 weeks
Change in protein carbonyls concentration by using standardized specific methods
14 weeks
Redox status assessed by change in paraoxonase
Time Frame: 14 weeks
Change in paraoxonase concentration by using standardized specific methods
14 weeks
Redox status assessed by change in superoxide dismutase
Time Frame: 14 weeks
Change in superoxide dismutase concentration by using standardized specific methods
14 weeks
Redox status assessed by change in catalase
Time Frame: 14 weeks
Change in catalase concentration by using standardized specific methods
14 weeks
Redox status assessed by change in glutathione
Time Frame: 14 weeks
Change in glutathione concentration by using standardized specific methods
14 weeks
Redox status assessed by change in glutathione reductase
Time Frame: 14 weeks
Change in glutathione reductase concentration by using standardized specific methods
14 weeks
Redox status assessed by change in glutathione peroxidase
Time Frame: 14 weeks
Change in glutathione peroxidase concentration by using standardized specific methods
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 4, 2017

Primary Completion (ACTUAL)

September 30, 2017

Study Completion (ACTUAL)

December 10, 2017

Study Registration Dates

First Submitted

June 22, 2016

First Submitted That Met QC Criteria

July 15, 2016

First Posted (ESTIMATE)

July 19, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 13, 2019

Last Update Submitted That Met QC Criteria

November 12, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UACJ-ICB-2016-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Will be published in index journals

IPD Sharing Time Frame

October 2019

IPD Sharing Access Criteria

Spirulina and exercise

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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