Cardiovascular DiseasesNCT02837666
Hypolipidemic and Antioxidant Capacity of Spirulina and Exercise
A study testing Supplementation with Spirulina maxima, Washout and Isoenergetic diet in people with Cardiovascular Diseases, run by Universidad Autonoma de Ciudad Juarez at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Supplementation with Spirulina maxima, Washout and Isoenergetic diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteMexico
- Study dates
- 4 May 2017to 10 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overweight (Body mass index (BMI): 25-29.9 kg/m2) and obese (BMI: > 30 kg/m2) persons
Who cannot join
- Taking drugs and/or food or vitamin supplements
- diabetes
- have a physical or electrocardiographic injury that prevents them from engaging in regular physical exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Supplementation with Spirulina maxima, Washout, Supplementation with placebo, Isoenergetic diet, Exercise program
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplementation with Spirulina maximaDietary supplement
Supplementation with Spirulina maxima (4.5 g/d) in capsules during 6 weeks.
WashoutOther
2 weeks washout period to each study subject to avoid any possible carryover effect.
Supplementation with placeboOther
Supplementation with placebo (4.5 g/d) in capsules during 6 weeks.
Isoenergetic dietOther
All participants will have a personal isoenergetic diet according to their height, weight, body composition and daily physical activity during 14 weeks
Exercise programOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Supplementation with Spirulina maxima; Other: Washout; Other: Supplementation with placebo; Other: Isoenergetic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 weeks
Secondary outcomes (13)
General fitness assessed by change in maximum oxygen consumption
Change in maximum oxygen consumption by using a gas analyzer (Cortex Metalizer 3B)
Measured: 14 weeks
General fitness assessed by change in heart rate
Change in heart rate by using a pulsometer (Polar HT7)
Measured: 14 weeks
General fitness assessed by change in lactate
Change in lactate concentration by using an automatized method (YSI lactate analyzer-1600)
Measured: 14 weeks
General fitness assessed by change in body mass
Change in body fat mass and body lean mass by using pletysmography (BOD-POD)
Measured: 14 weeks
General fitness assessed by change in blood pressure
Change in blood pressure by using an aneroid sphygmomanometer (Edimetric, Medical Technologies)
Measured: 14 weeks
Redox status assessed by change in malondialdehyde
Change in malondialdehyde concentration by using standardized specific methods
Measured: 14 weeks
Redox status assessed by change in protein carbonyls
Change in protein carbonyls concentration by using standardized specific methods
Measured: 14 weeks
Redox status assessed by change in paraoxonase
Change in paraoxonase concentration by using standardized specific methods
Measured: 14 weeks
Redox status assessed by change in superoxide dismutase
Change in superoxide dismutase concentration by using standardized specific methods
Measured: 14 weeks
Redox status assessed by change in catalase
Change in catalase concentration by using standardized specific methods
Measured: 14 weeks
Redox status assessed by change in glutathione
Change in glutathione concentration by using standardized specific methods
Measured: 14 weeks
Redox status assessed by change in glutathione reductase
Change in glutathione reductase concentration by using standardized specific methods
Measured: 14 weeks
Redox status assessed by change in glutathione peroxidase
Change in glutathione peroxidase concentration by using standardized specific methods
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study start4 May 2017
- Primary completion30 Sep 2017
- Study completion10 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Ciudad Juarez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco A Hernandez-Lepe, MS, Principal investigator, Universidad Autonoma de Ciudad JuarezArnulfo Ramos-Jimenez, phD, Study director, Universidad Autonoma de Ciudad Juarez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837666
- Sponsor's protocol ID
- UACJ-ICB-2016-01
- Status last verified
- Oct 2019
- First submitted
- 22 Jun 2016
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will be published in index journals
Publications
Genest J, Frohlich J, Fodor G, McPherson R; Working Group on Hypercholesterolemia and Other Dyslipidemias. Recommendations for the management of dyslipidemia and the prevention of cardiovascular disease: summary of the 2003 update. CMAJ. 2003 Oct 28;169(9):921-4. No abstract available.
PubMed 14581310Ebbeling CB, Pawlak DB, Ludwig DS. Childhood obesity: public-health crisis, common sense cure. Lancet. 2002 Aug 10;360(9331):473-82. doi: 10.1016/S0140-6736(02)09678-2.
PubMed 12241736Furukawa S, Fujita T, Shimabukuro M, Iwaki M, Yamada Y, Nakajima Y, Nakayama O, Makishima M, Matsuda M, Shimomura I. Increased oxidative stress in obesity and its impact on metabolic syndrome. J Clin Invest. 2004 Dec;114(12):1752-61. doi: 10.1172/JCI21625.
PubMed 15599400Li S, Chen W, Srinivasan SR, Bond MG, Tang R, Urbina EM, Berenson GS. Childhood cardiovascular risk factors and carotid vascular changes in adulthood: the Bogalusa Heart Study. JAMA. 2003 Nov 5;290(17):2271-6. doi: 10.1001/jama.290.17.2271.
PubMed 14600185Halliwell B, Cross CE. Oxygen-derived species: their relation to human disease and environmental stress. Environ Health Perspect. 1994 Dec;102 Suppl 10(Suppl 10):5-12. doi: 10.1289/ehp.94102s105.
PubMed 7705305Schieber M, Chandel NS. ROS function in redox signaling and oxidative stress. Curr Biol. 2014 May 19;24(10):R453-62. doi: 10.1016/j.cub.2014.03.034.
PubMed 24845678Madamanchi NR, Vendrov A, Runge MS. Oxidative stress and vascular disease. Arterioscler Thromb Vasc Biol. 2005 Jan;25(1):29-38. doi: 10.1161/01.ATV.0000150649.39934.13. Epub 2004 Nov 11.
PubMed 15539615Ble-Castillo JL, Rodriguez-Hernandez A, Miranda-Zamora R, Juarez-Oropeza MA, Diaz-Zagoya JC. Arthrospira maxima prevents the acute fatty liver induced by the administration of simvastatin, ethanol and a hypercholesterolemic diet to mice. Life Sci. 2002 Apr 19;70(22):2665-73. doi: 10.1016/s0024-3205(02)01512-6.
PubMed 12269393Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Munoz MA, Sorli JV, Martinez JA, Martinez-Gonzalez MA; PREDIMED Study Investigators. Primary prevention of cardiovascular disease with a Mediterranean diet. N Engl J Med. 2013 Apr 4;368(14):1279-90. doi: 10.1056/NEJMoa1200303. Epub 2013 Feb 25.
PubMed 23432189Hosseini SM, Khosravi-Darani K, Mozafari MR. Nutritional and medical applications of spirulina microalgae. Mini Rev Med Chem. 2013 Jun 1;13(8):1231-7. doi: 10.2174/1389557511313080009.
PubMed 23544470Chamorro G, Salazar M, Favila L, Bourges H. [Pharmacology and toxicology of Spirulina alga]. Rev Invest Clin. 1996 Sep-Oct;48(5):389-99. Spanish.
PubMed 9005517Iwata K, Inayama T, Kato T. Effects of Spirulina platensis on plasma lipoprotein lipase activity in fructose-induced hyperlipidemic rats. J Nutr Sci Vitaminol (Tokyo). 1990 Apr;36(2):165-71. doi: 10.3177/jnsv.36.165.
PubMed 2117648Riss J, Decorde K, Sutra T, Delage M, Baccou JC, Jouy N, Brune JP, Oreal H, Cristol JP, Rouanet JM. Phycobiliprotein C-phycocyanin from Spirulina platensis is powerfully responsible for reducing oxidative stress and NADPH oxidase expression induced by an atherogenic diet in hamsters. J Agric Food Chem. 2007 Sep 19;55(19):7962-7. doi: 10.1021/jf070529g. Epub 2007 Aug 16.
PubMed 17696484Torres-Duran PV, Ferreira-Hermosillo A, Juarez-Oropeza MA. Antihyperlipemic and antihypertensive effects of Spirulina maxima in an open sample of Mexican population: a preliminary report. Lipids Health Dis. 2007 Nov 26;6:33. doi: 10.1186/1476-511X-6-33.
PubMed 18039384[Cholesterolemia control in Spain, 2000. A tool for cardiovascular disease prevention. Ministry of Health and Consumption, Spanish Society of Cardiology and Spanish Society of Arteriosclerosis]. Rev Esp Salud Publica. 2000 May-Jun;74(3):215-53. Spanish.
PubMed 10918811
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Independent and Synergistic Effect of Spirulina Maxima With Exercise on General Fitness, Lipid Profile and Antioxidant Capacity in Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT02837666
- Acronym / sponsor ID
- UACJ-ICB-2016-01
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Universidad Autonoma de Ciudad JuarezUniversity, hospital or other
- Study start
- 4 May 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 10 Dec 2017 (actual)
- First posted
- 19 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group and supplementation | Active comparator | Dietary Supplement: Supplementation with Spirulina maxima, Other: Washout, Other: Supplementation with placebo, Other: Isoenergetic diet, Other: Exercise programSupplementation 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. |
| No exercise group and supplementation | Active comparator | Dietary Supplement: Supplementation with Spirulina maxima, Other: Washout, Other: Supplementation with placebo, Other: Isoenergetic dietSupplementation 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Overweight (Body mass index (BMI): 25-29.9 kg/m2) and obese (BMI: > 30 kg/m2) persons
Key exclusion criteria (3 listed)
- Taking drugs and/or food or vitamin supplements
- diabetes
- have a physical or electrocardiographic injury that prevents them from engaging in regular physical exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplementation with Spirulina maximaSupplementation with Spirulina maxima (4.5 g/d) in capsules during 6 weeks. | Dietary supplement | Exercise group and supplementation, No exercise group and supplementation |
| Washout2 weeks washout period to each study subject to avoid any possible carryover effect. | Other | Exercise group and supplementation, No exercise group and supplementation |
| Supplementation with placeboSupplementation with placebo (4.5 g/d) in capsules during 6 weeks. | Other | Exercise group and supplementation, No exercise group and supplementation |
| Isoenergetic dietAll participants will have a personal isoenergetic diet according to their height, weight, body composition and daily physical activity during 14 weeks | Other | Exercise group and supplementation, No exercise group and supplementation |
| Exercise programParticipants 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. | Other | Exercise group and supplementation |
Primary outcome
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
13 secondary outcomes
General fitness assessed by change in maximum oxygen consumption
Time frame: 14 weeks
General fitness assessed by change in heart rate
Time frame: 14 weeks
General fitness assessed by change in lactate
Time frame: 14 weeks
General fitness assessed by change in body mass
Time frame: 14 weeks
General fitness assessed by change in blood pressure
Time frame: 14 weeks
Redox status assessed by change in malondialdehyde
Time frame: 14 weeks
Redox status assessed by change in protein carbonyls
Time frame: 14 weeks
Redox status assessed by change in paraoxonase
Time frame: 14 weeks
Redox status assessed by change in superoxide dismutase
Time frame: 14 weeks
Redox status assessed by change in catalase
Time frame: 14 weeks
Redox status assessed by change in glutathione
Time frame: 14 weeks
Redox status assessed by change in glutathione reductase
Time frame: 14 weeks
Redox status assessed by change in glutathione peroxidase
Time frame: 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Background: PubMed 14581310Genest J, Frohlich J, Fodor G, McPherson R; Working Group on Hypercholesterolemia and Other Dyslipidemias. Recommendations for the management of dyslipidemia and the prevention of cardiovascular disease: summary of the 2003 update. CMAJ. 2003 Oct 28;169(9):921-4. No abstract available.
- Background: PubMed 12241736Ebbeling CB, Pawlak DB, Ludwig DS. Childhood obesity: public-health crisis, common sense cure. Lancet. 2002 Aug 10;360(9331):473-82. doi: 10.1016/S0140-6736(02)09678-2.
- Background: PubMed 15599400Furukawa S, Fujita T, Shimabukuro M, Iwaki M, Yamada Y, Nakajima Y, Nakayama O, Makishima M, Matsuda M, Shimomura I. Increased oxidative stress in obesity and its impact on metabolic syndrome. J Clin Invest. 2004 Dec;114(12):1752-61. doi: 10.1172/JCI21625.
- Background: PubMed 14600185Li S, Chen W, Srinivasan SR, Bond MG, Tang R, Urbina EM, Berenson GS. Childhood cardiovascular risk factors and carotid vascular changes in adulthood: the Bogalusa Heart Study. JAMA. 2003 Nov 5;290(17):2271-6. doi: 10.1001/jama.290.17.2271.
- Background: PubMed 7705305Halliwell B, Cross CE. Oxygen-derived species: their relation to human disease and environmental stress. Environ Health Perspect. 1994 Dec;102 Suppl 10(Suppl 10):5-12. doi: 10.1289/ehp.94102s105.
- Background: PubMed 24845678Schieber M, Chandel NS. ROS function in redox signaling and oxidative stress. Curr Biol. 2014 May 19;24(10):R453-62. doi: 10.1016/j.cub.2014.03.034.
- Background: PubMed 15539615Madamanchi NR, Vendrov A, Runge MS. Oxidative stress and vascular disease. Arterioscler Thromb Vasc Biol. 2005 Jan;25(1):29-38. doi: 10.1161/01.ATV.0000150649.39934.13. Epub 2004 Nov 11.
- Background: PubMed 12269393Ble-Castillo JL, Rodriguez-Hernandez A, Miranda-Zamora R, Juarez-Oropeza MA, Diaz-Zagoya JC. Arthrospira maxima prevents the acute fatty liver induced by the administration of simvastatin, ethanol and a hypercholesterolemic diet to mice. Life Sci. 2002 Apr 19;70(22):2665-73. doi: 10.1016/s0024-3205(02)01512-6.
- Background: PubMed 23432189Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Munoz MA, Sorli JV, Martinez JA, Martinez-Gonzalez MA; PREDIMED Study Investigators. Primary prevention of cardiovascular disease with a Mediterranean diet. N Engl J Med. 2013 Apr 4;368(14):1279-90. doi: 10.1056/NEJMoa1200303. Epub 2013 Feb 25.
- Background: PubMed 23544470Hosseini SM, Khosravi-Darani K, Mozafari MR. Nutritional and medical applications of spirulina microalgae. Mini Rev Med Chem. 2013 Jun 1;13(8):1231-7. doi: 10.2174/1389557511313080009.
- Background: PubMed 9005517Chamorro G, Salazar M, Favila L, Bourges H. [Pharmacology and toxicology of Spirulina alga]. Rev Invest Clin. 1996 Sep-Oct;48(5):389-99. Spanish.
- Background: PubMed 2117648Iwata K, Inayama T, Kato T. Effects of Spirulina platensis on plasma lipoprotein lipase activity in fructose-induced hyperlipidemic rats. J Nutr Sci Vitaminol (Tokyo). 1990 Apr;36(2):165-71. doi: 10.3177/jnsv.36.165.
- Statistics World Health Organization (WHO)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Will be published in index journals
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco A Hernandez-Lepe, MS principal investigator
Universidad Autonoma de Ciudad Juarez
Arnulfo Ramos-Jimenez, phD study director
Universidad Autonoma de Ciudad Juarez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplementation with Spirulina maxima, Washout and Isoenergetic diet in people with Cardiovascular Diseases, run by Universidad Autonoma de Ciudad Juarez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lipid profile (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02837666, which also lists 42 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.