Taurine Supplementation and Training Effects on Energy Metabolism, Inflammation and Oxidative Stress in Obese Women

NCT ID: NCT04279600

Last Updated: 2020-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-05-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blind placebo controlled study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Taurine

Intervention Type DIETARY_SUPPLEMENT

Taurine supplementation in capsules of 1 gram of taurine powder, total dosage: 3 grams/day

Exercise training

Intervention Type OTHER

4 weeks of combined exercise training (alternating strength and aerobic exercise), with a frequency of 3 times/week with 55 min/day.

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo supplementation in capsules of 1 gram of starch powder, total dosage: 3 grams/day

Exercise training

Intervention Type OTHER

4 weeks of combined exercise training (alternating strength and aerobic exercise), with a frequency of 3 times/week with 55 min/day.

Taurine supplementation

Taurine supplementation composed of capsules of taurine powder. Dosage: 3 grams/day Frequency: 1 time/day Duration: 8 weeks

Group Type EXPERIMENTAL

Taurine

Intervention Type DIETARY_SUPPLEMENT

Taurine supplementation in capsules of 1 gram of taurine powder, total dosage: 3 grams/day

Interventions

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Taurine

Taurine supplementation in capsules of 1 gram of taurine powder, total dosage: 3 grams/day

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo supplementation in capsules of 1 gram of starch powder, total dosage: 3 grams/day

Intervention Type DIETARY_SUPPLEMENT

Exercise training

4 weeks of combined exercise training (alternating strength and aerobic exercise), with a frequency of 3 times/week with 55 min/day.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Ellen Cristini de Freitas

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ellen C Freitas, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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School of Physical Education and Sport of Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 22237023 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22331997 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17244782 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20421291 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12514918 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12734789 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25833538 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14553911 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12456664 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16627576 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24276464 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15042451 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34255136 (View on PubMed)

Other Identifiers

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Taurine

Identifier Type: -

Identifier Source: org_study_id

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