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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04279600
Other study ID # Taurine
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date May 1, 2018

Study information

Verified date February 2020
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date May 1, 2018
Est. primary completion date September 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Taurine
Taurine supplementation in capsules of 1 gram of taurine powder, total dosage: 3 grams/day
Placebo
Placebo supplementation in capsules of 1 gram of starch powder, total dosage: 3 grams/day
Other:
Exercise training
4 weeks of combined exercise training (alternating strength and aerobic exercise), with a frequency of 3 times/week with 55 min/day.

Locations

Country Name City State
Brazil School of Physical Education and Sport of Ribeirão Preto Ribeirão Preto Sao Paulo

Sponsors (2)

Lead Sponsor Collaborator
University of Sao Paulo Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (12)

Boström P, Wu J, Jedrychowski MP, Korde A, Ye L, Lo JC, Rasbach KA, Boström EA, Choi JH, Long JZ, Kajimura S, Zingaretti MC, Vind BF, Tu H, Cinti S, Højlund K, Gygi SP, Spiegelman BM. A PGC1-a-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. — View Citation

de Almeida Martiniano AC, De Carvalho FG, Marchini JS, Garcia SB, Júnior 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. — View 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. — View 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. Epub 2007 Jan 23. — View Citation

Kraunsøe R, Boushel R, Hansen CN, Schjerling P, Qvortrup K, Støckel 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. — View Citation

Lourenço 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. Review. — View Citation

Marion-Latard F, Crampes F, Zakaroff-Girard A, De Glisezinski I, Harant I, Stich V, Thalamas C, Rivière 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. — View Citation

Schuller-Levis GB, Park E. Taurine: new implications for an old amino acid. FEMS Microbiol Lett. 2003 Sep 26;226(2):195-202. Review. — View 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. — View 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. Epub 2006 Apr 20. — View 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. — View 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. Epub 2003 May 9. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in white adipose tissue mitochondrial respiration at 8 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
Primary Change from baseline in indirect calorimetry at 8 weeks Change of energy expenditure and lipids oxidation were calculated at 8 weeks in comparision to the baseline. eight weeks
Primary Changes from baseline in interleukines levels at 8 weeks Change of inflammatory markers such as interleukines 6, 10 and 15 were calculated at 8 weeks in comparision to the baseline. eight weeks
Primary Changes from baseline in cytokine levels at 8 weeks Change of inflammatory markers such as adiponectin, resistin and adipsin were calculated at 8 weeks in comparision to the baseline. eight weeks
Primary Changes from baseline in glutathione peroxidase levels at 8 weeks Change of oxidative stress markers such as glutathione peroxidase were calculated at 8 weeks in comparision to the baseline. eight weeks
Primary Changes from baseline in superoxide dismutase levels at 8 weeks Change of oxidative stress markers such as superoxide dismutase were calculated at 8 weeks in comparision to the baseline. eight weeks
Primary Changes from baseline in macronutrient intake at 8 weeks Change of macronutrient intake were calculated at 8 weeks in comparision to the baseline. eight weeks
Primary Changes from baseline in total calorie intake at 8 weeks Change of total calorie intake were calculated at 8 weeks in comparision to the baseline. eight weeks
Primary Changes from baseline in body composition at 8 weeks Change of body composition through deuterium oxide method were calculated at 8 weeks in comparision to the baseline. eight weeks
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