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

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ClinicalTrials.gov Identifier: NCT04279600
Recruitment Status : Completed
First Posted : February 21, 2020
Last Update Posted : February 26, 2020
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Ellen Cristini de Freitas, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Taurine Dietary Supplement: Placebo Other: Exercise training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind placebo controlled study
Masking: Double (Participant, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Taurine Supplementation and Physical Training Effects on Adipose Tissue Mitochondrial Energy Metabolism, and Blood Inflammation and Oxidative Stress in Obese Women
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : September 1, 2017
Actual Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Taurine

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
Dietary Supplement: Taurine
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

Dietary Supplement: Taurine
Taurine supplementation in capsules of 1 gram of taurine 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.

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

Dietary Supplement: 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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04279600


Locations
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Brazil
School of Physical Education and Sport of Ribeirão Preto
Ribeirão Preto, Sao Paulo, Brazil, 14040-907
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Ellen C Freitas, PhD University of Sao Paulo
Publications:

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Responsible Party: Ellen Cristini de Freitas, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT04279600    
Other Study ID Numbers: Taurine
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes