Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2026-01-01 @ 2:05 AM
Study NCT ID:
NCT04279600
Status:
COMPLETED
Last Update Posted:
2020-02-26
First Post:
2019-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Taurine Supplementation and Training Effects on Energy Metabolism, Inflammation and Oxidative Stress in Obese Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013654', 'term': 'Taurine'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Supplement capsule packages were labeled as "Supplement A" and "Supplement B" and the nutrient (taurine or placebo- starch) was revealed after the end of the intervention.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-blind placebo controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-23', 'studyFirstSubmitDate': '2019-08-18', 'studyFirstSubmitQcDate': '2020-02-18', 'lastUpdatePostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in white adipose tissue mitochondrial respiration at 8 weeks', 'timeFrame': 'eight weeks', 'description': 'A subcutaneous adipose tissue sample collected for analysis of mitochondrial respiration (mitochondrial uncoupled state, phosphorylation state and electron transport system maximal capacity) were calculated at 8 weeks in comparison to the baseline.'}, {'measure': 'Change from baseline in indirect calorimetry at 8 weeks', 'timeFrame': 'eight weeks', 'description': 'Change of energy expenditure and lipids oxidation were calculated at 8 weeks in comparision to the baseline.'}, {'measure': 'Changes from baseline in interleukines levels at 8 weeks', 'timeFrame': 'eight weeks', 'description': 'Change of inflammatory markers such as interleukines 6, 10 and 15 were calculated at 8 weeks in comparision to the baseline.'}, {'measure': 'Changes from baseline in cytokine levels at 8 weeks', 'timeFrame': 'eight weeks', 'description': 'Change of inflammatory markers such as adiponectin, resistin and adipsin were calculated at 8 weeks in comparision to the baseline.'}, {'measure': 'Changes from baseline in glutathione peroxidase levels at 8 weeks', 'timeFrame': 'eight weeks', 'description': 'Change of oxidative stress markers such as glutathione peroxidase were calculated at 8 weeks in comparision to the baseline.'}, {'measure': 'Changes from baseline in superoxide dismutase levels at 8 weeks', 'timeFrame': 'eight weeks', 'description': 'Change of oxidative stress markers such as superoxide dismutase were calculated at 8 weeks in comparision to the baseline.'}, {'measure': 'Changes from baseline in macronutrient intake at 8 weeks', 'timeFrame': 'eight weeks', 'description': 'Change of macronutrient intake were calculated at 8 weeks in comparision to the baseline.'}, {'measure': 'Changes from baseline in total calorie intake at 8 weeks', 'timeFrame': 'eight weeks', 'description': 'Change of total calorie intake were calculated at 8 weeks in comparision to the baseline.'}, {'measure': 'Changes from baseline in body composition at 8 weeks', 'timeFrame': 'eight weeks', 'description': 'Change of body composition through deuterium oxide method were calculated at 8 weeks in comparision to the baseline.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '22237023', 'type': 'BACKGROUND', 'citation': 'Bostrom P, Wu J, Jedrychowski MP, Korde A, Ye L, Lo JC, Rasbach KA, Bostrom EA, Choi JH, Long JZ, Kajimura S, Zingaretti MC, Vind BF, Tu H, Cinti S, Hojlund K, Gygi SP, Spiegelman BM. A PGC1-alpha-dependent myokine that drives brown-fat-like development of white fat and thermogenesis. Nature. 2012 Jan 11;481(7382):463-8. doi: 10.1038/nature10777.'}, {'pmid': '22331997', 'type': 'BACKGROUND', 'citation': 'Ghandforoush-Sattari M, Mashayekhi S, Krishna CV, Thompson JP, Routledge PA. Pharmacokinetics of oral taurine in healthy volunteers. J Amino Acids. 2010;2010:346237. doi: 10.4061/2010/346237. Epub 2010 Jun 29.'}, {'pmid': '17244782', 'type': 'BACKGROUND', 'citation': 'Heilbronn LK, Gan SK, Turner N, Campbell LV, Chisholm DJ. Markers of mitochondrial biogenesis and metabolism are lower in overweight and obese insulin-resistant subjects. J Clin Endocrinol Metab. 2007 Apr;92(4):1467-73. doi: 10.1210/jc.2006-2210. Epub 2007 Jan 23.'}, {'pmid': '20421291', 'type': 'BACKGROUND', 'citation': 'Kraunsoe R, Boushel R, Hansen CN, Schjerling P, Qvortrup K, Stockel M, Mikines KJ, Dela F. Mitochondrial respiration in subcutaneous and visceral adipose tissue from patients with morbid obesity. J Physiol. 2010 Jun 15;588(Pt 12):2023-32. doi: 10.1113/jphysiol.2009.184754. Epub 2010 Apr 26.'}, {'pmid': '12514918', 'type': 'BACKGROUND', 'citation': 'Lourenco R, Camilo ME. Taurine: a conditionally essential amino acid in humans? An overview in health and disease. Nutr Hosp. 2002 Nov-Dec;17(6):262-70.'}, {'pmid': '12734789', 'type': 'BACKGROUND', 'citation': 'Marion-Latard F, Crampes F, Zakaroff-Girard A, De Glisezinski I, Harant I, Stich V, Thalamas C, Riviere D, Lafontan M, Berlan M. Post-exercise increase of lipid oxidation after a moderate exercise bout in untrained healthy obese men. Horm Metab Res. 2003 Feb;35(2):97-103. doi: 10.1055/s-2003-39051.'}, {'pmid': '25833538', 'type': 'BACKGROUND', 'citation': 'de Almeida Martiniano AC, De Carvalho FG, Marchini JS, Garcia SB, Junior JE, Mauad FM, da Silva AS, de Moraes C, de Freitas EC. Effects of taurine supplementation on adipose tissue of obese trained rats. Adv Exp Med Biol. 2015;803:707-14. doi: 10.1007/978-3-319-15126-7_56. No abstract available.'}, {'pmid': '14553911', 'type': 'BACKGROUND', 'citation': 'Schuller-Levis GB, Park E. Taurine: new implications for an old amino acid. FEMS Microbiol Lett. 2003 Sep 26;226(2):195-202. doi: 10.1016/S0378-1097(03)00611-6.'}, {'pmid': '12456664', 'type': 'BACKGROUND', 'citation': 'Suzuki T, Suzuki T, Wada T, Saigo K, Watanabe K. Taurine as a constituent of mitochondrial tRNAs: new insights into the functions of taurine and human mitochondrial diseases. EMBO J. 2002 Dec 2;21(23):6581-9. doi: 10.1093/emboj/cdf656.'}, {'pmid': '16627576', 'type': 'BACKGROUND', 'citation': 'Tsuboyama-Kasaoka N, Shozawa C, Sano K, Kamei Y, Kasaoka S, Hosokawa Y, Ezaki O. Taurine (2-aminoethanesulfonic acid) deficiency creates a vicious circle promoting obesity. Endocrinology. 2006 Jul;147(7):3276-84. doi: 10.1210/en.2005-1007. Epub 2006 Apr 20.'}, {'pmid': '24276464', 'type': 'BACKGROUND', 'citation': 'Yin X, Lanza IR, Swain JM, Sarr MG, Nair KS, Jensen MD. Adipocyte mitochondrial function is reduced in human obesity independent of fat cell size. J Clin Endocrinol Metab. 2014 Feb;99(2):E209-16. doi: 10.1210/jc.2013-3042. Epub 2013 Nov 25.'}, {'pmid': '15042451', 'type': 'BACKGROUND', 'citation': 'Zhang M, Izumi I, Kagamimori S, Sokejima S, Yamagami T, Liu Z, Qi B. Role of taurine supplementation to prevent exercise-induced oxidative stress in healthy young men. Amino Acids. 2004 Mar;26(2):203-7. doi: 10.1007/s00726-003-0002-3. Epub 2003 May 9.'}, {'pmid': '34255136', 'type': 'DERIVED', 'citation': 'De Carvalho FG, Brandao CFC, Munoz VR, Batitucci G, Tavares MEA, Teixeira GR, Pauli JR, De Moura LP, Ropelle ER, Cintra DE, da Silva ASR, Junqueira-Franco MVM, Marchini JS, De Freitas EC. Taurine supplementation in conjunction with exercise modulated cytokines and improved subcutaneous white adipose tissue plasticity in obese women. Amino Acids. 2021 Sep;53(9):1391-1403. doi: 10.1007/s00726-021-03041-4. Epub 2021 Jul 13.'}]}, 'descriptionModule': {'briefSummary': 'Taurine supplementation researches have increased due to its antioxidant and anti-inflammatory actions, and its ability to modulate lipid metabolism by stimulating the expression of proteins that regulates mitochondrial biogenesis and increases respiratory function (PGC-1α and PPAR) and irisin release when associated to exercise. Since obesity can induce metabolic disorders including abnormal production of adipokines and activation of pro-inflammatory signaling pathways also mitochondrial metabolism dysfunction in the adipose tissue, the use of taurine would be a new strategy for obesity prevention and treatment. Moreover, the association of taurine and exercise could improve exercise effects, promote higher energy expenditure and increase mitochondrial respiration, consequently resulting in weight loss. Therefore, the present investigation aims to evaluate the effects of the association of taurine supplementation and a combined exercise training protocol (aerobic and strength) on resting energy expenditure, weight, body composition, blood markers of inflammation and oxidative stress, telomeres length, and mitochondrial function and the expression of genes that regulates energy metabolism and lipid oxidation in the white adipose tissue in obese women.', 'detailedDescription': 'A double-blind placebo-controlled study was conducted with 24 obese women (32.9±6.3 years). Capsules of taurine (3 grams) (GTau) or placebo (GP) were daily supplemented 2 hours before training. The training program was composed of aerobic and strength exercises during one hour, 3 times a week, for an 8-week period (intensity of 80% heart rate). The taurine supplemented group received only taurine capsules (3g/day) during 8 weeks. Measurement of weight, hip and waist circumference, and body composition (by Deuterium oxide) were performed before and after the intervention. Resting energy expenditure and nutrients oxidation were assessed by calorimetry.\n\nIn order to check the effects of the intervention, abdominal tissue biopsy will be performed for white adipose tissue analysis, evaluation of mitochondrial function and quantification of the expression of genes related to energy metabolism and lipid oxidation and taurine pathway; blood collection will be done for quantification of taurine levels, inflammatory (IL-10, IL-15, IL-6, IL-1, TNF-α, and CRP), adipokines (adiponectin, adipsin, resistin, fetuin and leptin) and oxidative stress (GPx, SOD and MDA) markers. Also, evaluation of telomere length was performed. Body composition was evaluated by deuterium oxide method, weight, waist and hip circumference were accessed. All the measurements were performed before and after the intervention period.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index of 30 to 40 kg / m²\n* Sedentary\n* No associated co morbidity\n\nExclusion Criteria:\n\n* Women who have a medical impediment to the practice of physical exercise\n* Women that have undergone bariatric surgery\n* Menopause, cancer or any metabolic disease\n* Smokers\n* Alcoholics\n* Insulin-dependent diabetes'}, 'identificationModule': {'nctId': 'NCT04279600', 'acronym': 'Taurine', 'briefTitle': 'Taurine Supplementation and Training Effects on Energy Metabolism, Inflammation and Oxidative Stress in Obese Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Taurine Supplementation and Physical Training Effects on Adipose Tissue Mitochondrial Energy Metabolism, and Blood Inflammation and Oxidative Stress in Obese Women', 'orgStudyIdInfo': {'id': 'Taurine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Taurine supplementation', 'description': 'Taurine supplementation composed of capsules of taurine powder. Dosage: 3 grams/day Frequency: 1 time/day Duration: 8 weeks', 'interventionNames': ['Dietary Supplement: Taurine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Taurine supplementation associated to exercise training', 'description': 'Taurine supplementation composed of capsules of taurine powder. Dosage: 3 grams/day Frequency: 1 time/day Duration: 8 weeks\n\nExercise training Exercise Protocol: a combination of strength and aerobic exercises Duration: 2 weeks of adaptation and 8 weeks of physical training. Frequency: 3 times/week Duration: 55 minutes/session Intensity: 75 to 90% of maximum heart rate', 'interventionNames': ['Dietary Supplement: Taurine', 'Other: Exercise training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo supplementation associated to exercise training', 'description': 'Placebo supplementation composed of capsules of starch powder. Dosage: 3 grams/day Frequency: 1 time/day Duration: 8 weeks\n\nExercise training Exercise Protocol: a combination of strength and aerobic exercises Duration: 2 weeks of adaptation and 8 weeks of physical training. Frequency: 3 times/week Duration: 55 minutes/session Intensity: 75 to 90% of maximum heart rate', 'interventionNames': ['Dietary Supplement: Placebo', 'Other: Exercise training']}], 'interventions': [{'name': 'Taurine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Taurine supplementation in capsules of 1 gram of taurine powder, total dosage: 3 grams/day', 'armGroupLabels': ['Taurine supplementation', 'Taurine supplementation associated to exercise training']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo supplementation in capsules of 1 gram of starch powder, total dosage: 3 grams/day', 'armGroupLabels': ['Placebo supplementation associated to exercise training']}, {'name': 'Exercise training', 'type': 'OTHER', 'description': '4 weeks of combined exercise training (alternating strength and aerobic exercise), with a frequency of 3 times/week with 55 min/day.', 'armGroupLabels': ['Placebo supplementation associated to exercise training', 'Taurine supplementation associated to exercise training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14040-907', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'School of Physical Education and Sport of Ribeirão Preto', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}], 'overallOfficials': [{'name': 'Ellen C Freitas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ellen Cristini de Freitas', 'investigatorAffiliation': 'University of Sao Paulo'}}}}