- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04279600
Taurine Supplementation and Training Effects on Energy Metabolism, Inflammation and Oxidative Stress in Obese Women (Taurine)
Taurine Supplementation and Physical Training Effects on Adipose Tissue Mitochondrial Energy Metabolism, and Blood Inflammation and Oxidative Stress in Obese Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
In 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sao Paulo
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Ribeirão Preto, Sao Paulo, Brazil, 14040-907
- School of Physical Education and Sport of Ribeirão Preto
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Body Mass Index of 30 to 40 kg / m²
- Sedentary
- No associated co morbidity
Exclusion Criteria:
- Women who have a medical impediment to the practice of physical exercise
- Women that have undergone bariatric surgery
- Menopause, cancer or any metabolic disease
- Smokers
- Alcoholics
- Insulin-dependent diabetes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Taurine supplementation
Taurine supplementation composed of capsules of taurine powder.
Dosage: 3 grams/day Frequency: 1 time/day Duration: 8 weeks
|
Taurine supplementation in capsules of 1 gram of taurine powder, total dosage: 3 grams/day
|
Active Comparator: Taurine supplementation associated to exercise training
Taurine supplementation composed of capsules of taurine powder. Dosage: 3 grams/day Frequency: 1 time/day Duration: 8 weeks Exercise 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 |
Taurine supplementation in capsules of 1 gram of taurine powder, total dosage: 3 grams/day
4 weeks of combined exercise training (alternating strength and aerobic exercise), with a frequency of 3 times/week with 55 min/day.
|
Placebo Comparator: Placebo supplementation associated to exercise training
Placebo supplementation composed of capsules of starch powder. Dosage: 3 grams/day Frequency: 1 time/day Duration: 8 weeks Exercise 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 |
4 weeks of combined exercise training (alternating strength and aerobic exercise), with a frequency of 3 times/week with 55 min/day.
Placebo supplementation in capsules of 1 gram of starch powder, total dosage: 3 grams/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in white adipose tissue mitochondrial respiration at 8 weeks
Time Frame: eight weeks
|
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.
|
eight weeks
|
Change from baseline in indirect calorimetry at 8 weeks
Time Frame: eight weeks
|
Change of energy expenditure and lipids oxidation were calculated at 8 weeks in comparision to the baseline.
|
eight weeks
|
Changes from baseline in interleukines levels at 8 weeks
Time Frame: eight weeks
|
Change of inflammatory markers such as interleukines 6, 10 and 15 were calculated at 8 weeks in comparision to the baseline.
|
eight weeks
|
Changes from baseline in cytokine levels at 8 weeks
Time Frame: eight weeks
|
Change of inflammatory markers such as adiponectin, resistin and adipsin were calculated at 8 weeks in comparision to the baseline.
|
eight weeks
|
Changes from baseline in glutathione peroxidase levels at 8 weeks
Time Frame: eight weeks
|
Change of oxidative stress markers such as glutathione peroxidase were calculated at 8 weeks in comparision to the baseline.
|
eight weeks
|
Changes from baseline in superoxide dismutase levels at 8 weeks
Time Frame: eight weeks
|
Change of oxidative stress markers such as superoxide dismutase were calculated at 8 weeks in comparision to the baseline.
|
eight weeks
|
Changes from baseline in macronutrient intake at 8 weeks
Time Frame: eight weeks
|
Change of macronutrient intake were calculated at 8 weeks in comparision to the baseline.
|
eight weeks
|
Changes from baseline in total calorie intake at 8 weeks
Time Frame: eight weeks
|
Change of total calorie intake were calculated at 8 weeks in comparision to the baseline.
|
eight weeks
|
Changes from baseline in body composition at 8 weeks
Time Frame: eight weeks
|
Change of body composition through deuterium oxide method were calculated at 8 weeks in comparision to the baseline.
|
eight weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: J Physiol. 2010 Oct 15; 588(Pt 20):4055.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Taurine
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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