Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2026-02-23 @ 6:29 AM
Study NCT ID:
NCT02837666
Status:
COMPLETED
Last Update Posted:
2019-11-13
First Post:
2016-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypolipidemic and Antioxidant Capacity of Spirulina and Exercise
Sponsor:
Organization:
Raw JSON
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'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-27', 'size': 320372, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-11-12T03:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2017-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-12', 'studyFirstSubmitDate': '2016-06-22', 'studyFirstSubmitQcDate': '2016-07-15', 'lastUpdatePostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in lipid profile', 'timeFrame': '14 weeks', 'description': 'Change in plasma triacylglycerols, total cholesterol, high density lipoproteins cholesterol, and low density lipoproteins cholesterol after each treatment by using standardized enzymatic methods'}], 'secondaryOutcomes': [{'measure': 'General fitness assessed by change in maximum oxygen consumption', 'timeFrame': '14 weeks', 'description': 'Change in maximum oxygen consumption by using a gas analyzer (Cortex Metalizer 3B)'}, {'measure': 'General fitness assessed by change in heart rate', 'timeFrame': '14 weeks', 'description': 'Change in heart rate by using a pulsometer (Polar HT7)'}, {'measure': 'General fitness assessed by change in lactate', 'timeFrame': '14 weeks', 'description': 'Change in lactate concentration by using an automatized method (YSI lactate analyzer-1600)'}, {'measure': 'General fitness assessed by change in body mass', 'timeFrame': '14 weeks', 'description': 'Change in body fat mass and body lean mass by using pletysmography (BOD-POD)'}, {'measure': 'General fitness assessed by change in blood pressure', 'timeFrame': '14 weeks', 'description': 'Change in blood pressure by using an aneroid sphygmomanometer (Edimetric, Medical Technologies)'}, {'measure': 'Redox status assessed by change in malondialdehyde', 'timeFrame': '14 weeks', 'description': 'Change in malondialdehyde concentration by using standardized specific methods'}, {'measure': 'Redox status assessed by change in protein carbonyls', 'timeFrame': '14 weeks', 'description': 'Change in protein carbonyls concentration by using standardized specific methods'}, {'measure': 'Redox status assessed by change in paraoxonase', 'timeFrame': '14 weeks', 'description': 'Change in paraoxonase concentration by using standardized specific methods'}, {'measure': 'Redox status assessed by change in superoxide dismutase', 'timeFrame': '14 weeks', 'description': 'Change in superoxide dismutase concentration by using standardized specific methods'}, {'measure': 'Redox status assessed by change in catalase', 'timeFrame': '14 weeks', 'description': 'Change in catalase concentration by using standardized specific methods'}, {'measure': 'Redox status assessed by change in glutathione', 'timeFrame': '14 weeks', 'description': 'Change in glutathione concentration by using standardized specific methods'}, {'measure': 'Redox status assessed by change in glutathione reductase', 'timeFrame': '14 weeks', 'description': 'Change in glutathione reductase concentration by using standardized specific methods'}, {'measure': 'Redox status assessed by change in glutathione peroxidase', 'timeFrame': '14 weeks', 'description': 'Change in glutathione peroxidase concentration by using standardized specific methods'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '14581310', 'type': 'BACKGROUND', 'citation': 'Genest J, Frohlich J, Fodor G, McPherson R; Working Group on Hypercholesterolemia and Other Dyslipidemias. 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JAMA. 2003 Nov 5;290(17):2271-6. doi: 10.1001/jama.290.17.2271.'}, {'pmid': '7705305', 'type': 'BACKGROUND', 'citation': 'Halliwell 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.'}, {'pmid': '24845678', 'type': 'BACKGROUND', 'citation': 'Schieber 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.'}, {'pmid': '15539615', 'type': 'BACKGROUND', 'citation': 'Madamanchi 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.'}, {'pmid': '12269393', 'type': 'BACKGROUND', 'citation': 'Ble-Castillo JL, Rodriguez-Hernandez A, Miranda-Zamora R, Juarez-Oropeza MA, Diaz-Zagoya JC. 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Mini Rev Med Chem. 2013 Jun 1;13(8):1231-7. doi: 10.2174/1389557511313080009.'}, {'pmid': '9005517', 'type': 'BACKGROUND', 'citation': 'Chamorro G, Salazar M, Favila L, Bourges H. [Pharmacology and toxicology of Spirulina alga]. Rev Invest Clin. 1996 Sep-Oct;48(5):389-99. Spanish.'}, {'pmid': '2117648', 'type': 'BACKGROUND', 'citation': 'Iwata 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.'}, {'pmid': '17696484', 'type': 'BACKGROUND', 'citation': 'Riss 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.'}, {'pmid': '18039384', 'type': 'BACKGROUND', 'citation': 'Torres-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.'}, {'pmid': '10918811', 'type': 'BACKGROUND', 'citation': '[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.'}, {'pmid': '19144121', 'type': 'BACKGROUND', 'citation': 'Fisher-Wellman K, Bloomer RJ. Acute exercise and oxidative stress: a 30 year history. Dyn Med. 2009 Jan 13;8:1. doi: 10.1186/1476-5918-8-1.'}, {'pmid': '16426710', 'type': 'BACKGROUND', 'citation': 'Morillas-Ruiz JM, Villegas Garcia JA, Lopez FJ, Vidal-Guevara ML, Zafrilla P. Effects of polyphenolic antioxidants on exercise-induced oxidative stress. Clin Nutr. 2006 Jun;25(3):444-53. doi: 10.1016/j.clnu.2005.11.007. Epub 2006 Jan 19.'}, {'pmid': '24075894', 'type': 'BACKGROUND', 'citation': 'Aoi W, Naito Y, Yoshikawa T. Role of oxidative stress in impaired insulin signaling associated with exercise-induced muscle damage. Free Radic Biol Med. 2013 Dec;65:1265-1272. doi: 10.1016/j.freeradbiomed.2013.09.014. Epub 2013 Sep 27.'}, {'pmid': '18191748', 'type': 'BACKGROUND', 'citation': 'Gomez-Cabrera MC, Domenech E, Vina J. Moderate exercise is an antioxidant: upregulation of antioxidant genes by training. Free Radic Biol Med. 2008 Jan 15;44(2):126-31. doi: 10.1016/j.freeradbiomed.2007.02.001. Epub 2007 Feb 9.'}, {'pmid': '23698776', 'type': 'BACKGROUND', 'citation': 'Savini I, Catani MV, Evangelista D, Gasperi V, Avigliano L. Obesity-associated oxidative stress: strategies finalized to improve redox state. Int J Mol Sci. 2013 May 21;14(5):10497-538. doi: 10.3390/ijms140510497.'}, {'pmid': '11349530', 'type': 'BACKGROUND', 'citation': 'Upasani CD, Khera A, Balaraman R. Effect of lead with vitamin E, C, or Spirulina on malondialdehyde, conjugated dienes and hydroperoxides in rats. Indian J Exp Biol. 2001 Jan;39(1):70-4.'}, {'pmid': '16177207', 'type': 'BACKGROUND', 'citation': 'Nagaoka S, Shimizu K, Kaneko H, Shibayama F, Morikawa K, Kanamaru Y, Otsuka A, Hirahashi T, Kato T. A novel protein C-phycocyanin plays a crucial role in the hypocholesterolemic action of Spirulina platensis concentrate in rats. J Nutr. 2005 Oct;135(10):2425-30. doi: 10.1093/jn/135.10.2425.'}, {'pmid': '17530160', 'type': 'BACKGROUND', 'citation': 'Thaakur SR, Jyothi B. Effect of spirulina maxima on the haloperidol induced tardive dyskinesia and oxidative stress in rats. J Neural Transm (Vienna). 2007 Sep;114(9):1217-25. doi: 10.1007/s00702-007-0744-2. Epub 2007 May 26.'}, {'type': 'BACKGROUND', 'citation': 'Pescatello, Linda S., American College of Sports Medicine. Acsms Guidelines for Exercise Testing and Prescription. Wolters Kluwer/Lippincott Williams & Wilkins Health; Edición: 9th revised North American ed. 2014. 480 p'}, {'pmid': '4337382', 'type': 'BACKGROUND', 'citation': 'Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972 Jun;18(6):499-502. No abstract available.'}, {'type': 'BACKGROUND', 'citation': 'Montoya, C. G., Ospina, C. O., Mesa, N. S., Cano, C. M., Lobo, M., Arias, P. G. G., & Pérez, B. R. Actividad antioxidante e inhibición de la peroxidación lipídica de extractos de frutos de mortiño (Vaccinium meridionale SW). Boletín Latinoamericano y del Caribe de Plantas Medicinales y Aromáticas, 2009; 8 (6): 519-528.'}, {'type': 'BACKGROUND', 'citation': 'Alvarez-Parrilla, E., de la Rosa, L.A., Torres-Rivas, F., Rodrigo-Garcia, J., González-Aguilar, G. Complexation of apple antioxidants: chlorogenic acid, quercetin and rutin by β-cyclodextrin (β-CD). Journal of inclusion phenomena and macrocyclic chemistry, 2005; 53 (1-2): 121-129.'}, {'pmid': '20057381', 'type': 'BACKGROUND', 'citation': 'Weydert CJ, Cullen JJ. Measurement of superoxide dismutase, catalase and glutathione peroxidase in cultured cells and tissue. Nat Protoc. 2010 Jan;5(1):51-66. doi: 10.1038/nprot.2009.197. Epub 2009 Dec 17.'}, {'pmid': '9721075', 'type': 'BACKGROUND', 'citation': 'Jones DP, Carlson JL, Samiec PS, Sternberg P Jr, Mody VC Jr, Reed RL, Brown LA. Glutathione measurement in human plasma. Evaluation of sample collection, storage and derivatization conditions for analysis of dansyl derivatives by HPLC. Clin Chim Acta. 1998 Jul 28;275(2):175-84. doi: 10.1016/s0009-8981(98)00089-8.'}, {'pmid': '20354344', 'type': 'BACKGROUND', 'citation': 'Cheong SH, Kim MY, Sok DE, Hwang SY, Kim JH, Kim HR, Lee JH, Kim YB, Kim MR. Spirulina prevents atherosclerosis by reducing hypercholesterolemia in rabbits fed a high-cholesterol diet. J Nutr Sci Vitaminol (Tokyo). 2010;56(1):34-40. doi: 10.3177/jnsv.56.34.'}, {'pmid': '21569626', 'type': 'BACKGROUND', 'citation': 'Moura LP, Puga GM, Beck WR, Teixeira IP, Ghezzi AC, Silva GA, Mello MA. Exercise and spirulina control non-alcoholic hepatic steatosis and lipid profile in diabetic Wistar rats. Lipids Health Dis. 2011 May 15;10:77. doi: 10.1186/1476-511X-10-77.'}, {'pmid': '25331487', 'type': 'BACKGROUND', 'citation': 'Mazokopakis EE, Papadomanolaki MG, Fousteris AA, Kotsiris DA, Lampadakis IM, Ganotakis ES. The hepatoprotective and hypolipidemic effects of Spirulina (Arthrospira platensis) supplementation in a Cretan population with non-alcoholic fatty liver disease: a prospective pilot study. Ann Gastroenterol. 2014;27(4):387-394.'}, {'pmid': '23754631', 'type': 'BACKGROUND', 'citation': 'Mazokopakis EE, Starakis IK, Papadomanolaki MG, Mavroeidi NG, Ganotakis ES. The hypolipidaemic effects of Spirulina (Arthrospira platensis) supplementation in a Cretan population: a prospective study. J Sci Food Agric. 2014 Feb;94(3):432-7. doi: 10.1002/jsfa.6261. Epub 2013 Jul 10.'}, {'type': 'BACKGROUND', 'citation': 'Anitha, L., Chandralekha, K. Effect of supplementation of spirulina on blood glucose, glycosylated hemoglobin and lipid profile of male non-insulin dependent diabetics. Asian J Exp Biol Sci; 2010; 1: 36-46.'}, {'pmid': '25496727', 'type': 'BACKGROUND', 'citation': 'Ngo-Matip ME, Pieme CA, Azabji-Kenfack M, Biapa PC, Germaine N, Heike E, Moukette BM, Emmanuel K, Philippe S, Mbofung CM, Ngogang JY. Effects of Spirulina platensis supplementation on lipid profile in HIV-infected antiretroviral naive patients in Yaounde-Cameroon: a randomized trial study. Lipids Health Dis. 2014 Dec 13;13:191. doi: 10.1186/1476-511X-13-191.'}, {'pmid': '16944194', 'type': 'BACKGROUND', 'citation': 'Lu HK, Hsieh CC, Hsu JJ, Yang YK, Chou HN. Preventive effects of Spirulina platensis on skeletal muscle damage under exercise-induced oxidative stress. Eur J Appl Physiol. 2006 Sep;98(2):220-6. doi: 10.1007/s00421-006-0263-0. Epub 2006 Aug 30.'}, {'pmid': '20010119', 'type': 'BACKGROUND', 'citation': 'Kalafati M, Jamurtas AZ, Nikolaidis MG, Paschalis V, Theodorou AA, Sakellariou GK, Koutedakis Y, Kouretas D. Ergogenic and antioxidant effects of spirulina supplementation in humans. Med Sci Sports Exerc. 2010 Jan;42(1):142-51. doi: 10.1249/MSS.0b013e3181ac7a45.'}, {'pmid': '12226146', 'type': 'BACKGROUND', 'citation': 'Fenster CP, Weinsier RL, Darley-Usmar VM, Patel RP. Obesity, aerobic exercise, and vascular disease: the role of oxidant stress. Obes Res. 2002 Sep;10(9):964-8. doi: 10.1038/oby.2002.131.'}, {'pmid': '26268076', 'type': 'BACKGROUND', 'citation': 'Hernandez Lepe MA, Wall-Medrano A, Juarez-Oropeza MA, Ramos-Jimenez A, Hernandez-Torres RP. [SPIRULINA AND ITS HYPOLIPIDEMIC AND ANTIOXIDANT EFFECTS IN HUMANS: A SYSTEMATIC REVIEW]. Nutr Hosp. 2015 Aug 1;32(2):494-500. doi: 10.3305/nh.2015.32.2.9100. Spanish.'}, {'pmid': '31652765', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '30275428', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '28645949', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.who.int/mediacentre/factsheets/fs317/en/', 'label': 'Statistics World Health Organization (WHO)'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThere 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.\n\nMethods/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.\n\nDiscussion: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overweight (Body mass index (BMI): 25-29.9 kg/m2) and obese (BMI: \\> 30 kg/m2) persons\n\nExclusion Criteria:\n\n* Taking drugs and/or food or vitamin supplements\n* diabetes\n* have a physical or electrocardiographic injury that prevents them from engaging in regular physical exercise'}, 'identificationModule': {'nctId': 'NCT02837666', 'briefTitle': 'Hypolipidemic and Antioxidant Capacity of Spirulina and Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Autonoma de Ciudad Juarez'}, 'officialTitle': 'Independent and Synergistic Effect of Spirulina Maxima With Exercise on General Fitness, Lipid Profile and Antioxidant Capacity in Overweight and Obese Subjects', 'orgStudyIdInfo': {'id': 'UACJ-ICB-2016-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise group and supplementation', 'description': '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.', 'interventionNames': ['Dietary Supplement: Supplementation with Spirulina maxima', 'Other: Washout', 'Other: Supplementation with placebo', 'Other: Isoenergetic diet', 'Other: Exercise program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No exercise group and supplementation', 'description': '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.', 'interventionNames': ['Dietary Supplement: Supplementation with Spirulina maxima', 'Other: Washout', 'Other: Supplementation with placebo', 'Other: Isoenergetic diet']}], 'interventions': [{'name': 'Supplementation with Spirulina maxima', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Supplementation with Spirulina maxima (4.5 g/d) in capsules during 6 weeks.', 'armGroupLabels': ['Exercise group and supplementation', 'No exercise group and supplementation']}, {'name': 'Washout', 'type': 'OTHER', 'description': '2 weeks washout period to each study subject to avoid any possible carryover effect.', 'armGroupLabels': ['Exercise group and supplementation', 'No exercise group and supplementation']}, {'name': 'Supplementation with placebo', 'type': 'OTHER', 'description': 'Supplementation with placebo (4.5 g/d) in capsules during 6 weeks.', 'armGroupLabels': ['Exercise group and supplementation', 'No exercise group and supplementation']}, {'name': 'Isoenergetic diet', 'type': 'OTHER', 'description': 'All participants will have a personal isoenergetic diet according to their height, weight, body composition and daily physical activity during 14 weeks', 'armGroupLabels': ['Exercise group and supplementation', 'No exercise group and supplementation']}, {'name': 'Exercise program', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Exercise group and supplementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32310', 'city': 'Juárez', 'state': 'Chihuahua', 'country': 'Mexico', 'facility': 'Universidad Autonoma de Ciudad Juarez', 'geoPoint': {'lat': 30.30982, 'lon': -108.07852}}], 'overallOfficials': [{'name': 'Marco A Hernandez-Lepe, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Autonoma de Ciudad Juarez'}, {'name': 'Arnulfo Ramos-Jimenez, phD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad Autonoma de Ciudad Juarez'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'October 2019', 'ipdSharing': 'YES', 'description': 'Will be published in index journals', 'accessCriteria': 'Spirulina and exercise'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Autonoma de Ciudad Juarez', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}