Hypolipidemic and Antioxidant Capacity of Spirulina and Exercise

NCT02837666 | Completed DMC

• 1 other identifier: UACJ-ICB-2016-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Change in lipid profile

  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 Outcomes (13)

• General fitness assessed by change in maximum oxygen consumption

  14 weeks

• General fitness assessed by change in heart rate

  14 weeks

• General fitness assessed by change in lactate

  14 weeks

• General fitness assessed by change in body mass

  14 weeks

• General fitness assessed by change in blood pressure

  14 weeks

Study Arms (2)

Exercise group and supplementation

ACTIVE COMPARATOR

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; Other: Washout; Other: Supplementation with placebo; Other: Isoenergetic diet; Other: Exercise program

No exercise group and supplementation

ACTIVE COMPARATOR

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; Other: Washout; Other: Supplementation with placebo; Other: Isoenergetic diet

Interventions

Supplementation with Spirulina maxima DIETARY_SUPPLEMENT

Supplementation with Spirulina maxima (4.5 g/d) in capsules during 6 weeks.

Exercise group and supplementation; No exercise group and supplementation

Washout OTHER

2 weeks washout period to each study subject to avoid any possible carryover effect.

Exercise group and supplementation; No exercise group and supplementation

Supplementation with placebo OTHER

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

Exercise group and supplementation; No exercise group and supplementation

Isoenergetic diet OTHER

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

Exercise group and supplementation; No exercise group and supplementation

Exercise program OTHER

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.

Exercise group and supplementation

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Overweight (Body mass index (BMI): 25-29.9 kg/m2) and obese (BMI: \> 30 kg/m2) persons

You may not qualify if:

• Taking drugs and/or food or vitamin supplements
• diabetes
• have a physical or electrocardiographic injury that prevents them from engaging in regular physical exercise

Sponsors & Collaborators

• Universidad Autonoma de Ciudad Juarez: lead

Study Sites (1)

Universidad Autonoma de Ciudad Juarez

Juárez, Chihuahua, 32310, Mexico

Location

Related Publications (42)

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• Hernandez-Lepe MA, Olivas-Aguirre FJ, Gomez-Miranda LM, Hernandez-Torres RP, Manriquez-Torres JJ, Ramos-Jimenez A. Systematic Physical Exercise and Spirulina maxima Supplementation Improve Body Composition, Cardiorespiratory Fitness, and Blood Lipid Profile: Correlations of a Randomized Double-Blind Controlled Trial. Antioxidants (Basel). 2019 Oct 23;8(11):507. doi: 10.3390/antiox8110507.

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• Hernandez-Lepe MA, Lopez-Diaz JA, Juarez-Oropeza MA, Hernandez-Torres RP, Wall-Medrano A, Ramos-Jimenez A. Effect of Arthrospira (Spirulina) maxima Supplementation and a Systematic Physical Exercise Program on the Body Composition and Cardiorespiratory Fitness of Overweight or Obese Subjects: A Double-Blind, Randomized, and Crossover Controlled Trial. Mar Drugs. 2018 Oct 1;16(10):364. doi: 10.3390/md16100364.

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• Hernandez-Lepe MA, Lopez-Diaz JA, Rosa LA, Hernandez-Torres RP, Wall-Medrano A, Juarez-Oropeza MA, Pedraza-Chaverri J, Urquidez-Romero R, Ramos-Jimenez A. Double-blind randomised controlled trial of the independent and synergistic effect of Spirulina maxima with exercise (ISESE) on general fitness, lipid profile and redox status in overweight and obese subjects: study protocol. BMJ Open. 2017 Jun 23;7(6):e013744. doi: 10.1136/bmjopen-2016-013744.

  PMID: 28645949 DERIVED

Related Links

• Statistics World Health Organization (WHO)

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Dietary Supplements; WASH protein, Drosophila; Resistance Training

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Marco A Hernandez-Lepe, MS

  Universidad Autonoma de Ciudad Juarez

  PRINCIPAL INVESTIGATOR

• Arnulfo Ramos-Jimenez, phD

  Universidad Autonoma de Ciudad Juarez

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: July 19, 2016
• Study Start: May 4, 2017
• Primary Completion: September 30, 2017
• Study Completion: December 10, 2017
• Last Updated: November 13, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: October 2019
• Access Criteria: Spirulina and exercise

Locations

ME (1)