NCT04279600

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2019

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

4 months

First QC Date

August 18, 2019

Last Update Submit

February 23, 2020

Conditions

Outcome Measures

Primary Outcomes (9)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (3)

Taurine supplementation

EXPERIMENTAL

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

Dietary Supplement: Taurine

Taurine supplementation associated to exercise training

ACTIVE COMPARATOR

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

Dietary Supplement: TaurineOther: Exercise training

Placebo supplementation associated to exercise training

PLACEBO COMPARATOR

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

Dietary Supplement: PlaceboOther: Exercise training

Interventions

TaurineDIETARY_SUPPLEMENT

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

Taurine supplementationTaurine supplementation associated to exercise training
PlaceboDIETARY_SUPPLEMENT

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

Placebo supplementation associated to exercise training

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 trainingTaurine supplementation associated to exercise training

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body Mass Index of 30 to 40 kg / m²
  • Sedentary
  • No associated co morbidity

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Physical Education and Sport of Ribeirão Preto

Ribeirão Preto, São Paulo, 14040-907, Brazil

Location

Related Publications (13)

  • 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: 22237023BACKGROUND
  • 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: 22331997BACKGROUND
  • 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: 17244782BACKGROUND
  • 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: 20421291BACKGROUND
  • 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: 12514918BACKGROUND
  • 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: 12734789BACKGROUND
  • 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: 25833538BACKGROUND
  • 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: 14553911BACKGROUND
  • 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: 12456664BACKGROUND
  • 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: 16627576BACKGROUND
  • 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: 24276464BACKGROUND
  • 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: 15042451BACKGROUND
  • 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.

MeSH Terms

Conditions

Obesity

Interventions

TaurineExercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsSulfonic AcidsSulfur AcidsSulfur CompoundsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ellen C Freitas, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double-blind placebo controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 18, 2019

First Posted

February 21, 2020

Study Start

May 1, 2017

Primary Completion

September 1, 2017

Study Completion

May 1, 2018

Last Updated

February 26, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations