Taurine Supplementation Associated or Not With Exercise: Effect on Browning of White Adipose Tissue in Elderly Women With Sarcopenic Obesity

Study Overview
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Brief Summary
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The aging process is followed by metabolic and body composition changes, increasing the risk of obesity and sarcopenia. The coexistence of these conditions acts synergistically on each other and is known as sarcopenic obesity. Beige adipose tissue is a tissue type that emerges from subcutaneous white adipose tissue (WAT), altering its phenotype to resemble the thermogenic functions of brown adipose tissue (BAT) in response to beta-adrenergic stimuli. Some in vitro and animal studies suggest that taurine supplementation and physical exercise are effective interventions in stimulating the aforementioned tissue, promoting what is known as WAT darkening, improving energy metabolism and showing benefits on the maintenance of muscle mass via stimulation of the coactivating protein PGC1α. These investigations are scarce in humans and could help health professionals in the adjuvant treatment of sarcopenic obesity. Therefore, the aim of the present study is to analyze the effects of taurine supplementation associated or not with physical exercise on the darkening of the WAT in sarcopenic obese elderly women.

Detailed Description
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The aging process is followed by metabolic and body composition changes, increasing the risk of obesity and sarcopenia. The coexistence of these conditions acts synergistically on each other and is known as sarcopenic obesity. Beige adipose tissue is a tissue type that emerges from subcutaneous white adipose tissue (WAT), altering its phenotype to resemble the thermogenic functions of brown adipose tissue (BAT) in response to beta-adrenergic stimuli. Some in vitro and animal studies suggest that taurine supplementation and physical exercise are effective interventions in stimulating the aforementioned tissue, promoting what is known as WAT darkening, improving energy metabolism and showing benefits on the maintenance of muscle mass via stimulation of the coactivating protein PGC1α. These investigations are scarce in humans and could help health professionals in the adjuvant treatment of sarcopenic obesity. Therefore, the aim of the present study is to analyze the effects of taurine supplementation associated or not with physical exercise on the darkening of the WAT in sarcopenic obese elderly women. Volunteers with low appendicular lean mass (<15 kg) and body mass index (BMI) between 30 and 40 kg/m² will be recruited. These will be subdivided into 4 groups: control group (Cont), taurine (Tau), exercise (Exe) and exercise and taurine (Exe +Tau) and the duration of the intervention for all groups will be 16 weeks. Data related to anthropometry, body composition, biochemical tests, and food intake will be collected. To evaluate the effects on the darkening, a biopsy of the abdominal subcutaneous white adipose tissue will be performed to analyze protein, lipidomic and genetic parameters of this tissue pre and post intervention. Data will be analyzed by Analysis of Variance (ANOVA) or Kruskal-Wallis test depending on the normality of the data that will be tested by Shapiro-Wilk. A significance level for p <0.05 will be admitted. All analyzes will be performed in SPSS version 20 software.

Official Title
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Taurine Supplementation Associated or Not With Exercise: Effect on Browning of White Adipose Tissue in Elderly Women With Sarcopenic Obesity

Conditions
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Browning of Subcutaneous White Adipose Tissue Post Intervention, Metabolic and Inflammatory Variables Post Intervention

Intervention / Treatment
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* Dietary Supplement: Taurine supplementation
* Other: Pshysical exercise
* Other: Placebo control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI between 30 and 40kg/m²; Appendicular lean mass below 15 kg; Dynamometry below the cutoff point adjusted for sex and BMI (less than or equal to 21kg); Sit and stand test below the cut-off point adjusted for the age group, considering the number of repetitions in 30 seconds; Present medical certificate to perform physical exercise Exclusion Criteria: alcoholics smokers diseases that prevents the practice of physical activity medical impediment to the practice of physical exercise throughout the study infectious diseases coronary diseases chronic kidney diseases undergoing nutritional monitoring or weight loss treatment score ≤13 for cognitive screening on the Mini-Mental State Examination (MMSE)

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Taurine and Exercise (Tau+Exe)<br>Individuals who will receive 3g of taurine supplementation combined with physical training in the period of 16 weeks | Dietary Supplement: Taurine supplementation<br>* Participants will receive 3g of taurine to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks.<br>Other: Pshysical exercise<br>* Participants will perform a multicomponent type workout that explores strength, aerobic and balance capacities with load progression every 15 days. The sessions will last 60 minutes each, being held three times a week with a day of rest in between. The intervention will last 16 weeks<br>|
| Experimental: Taurine (Tau)<br>Individuals who will receive 3g of taurine supplementation | Dietary Supplement: Taurine supplementation<br>* Participants will receive 3g of taurine to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks.<br>|
| Experimental: Exercise (Exe)<br>Individuals who will perform a physical training and receive a placebo supplementation in the period of 16 weeks | Other: Pshysical exercise<br>* Participants will perform a multicomponent type workout that explores strength, aerobic and balance capacities with load progression every 15 days. The sessions will last 60 minutes each, being held three times a week with a day of rest in between. The intervention will last 16 weeks<br>|
| Placebo Comparator: Placebo (Cont)<br>Individuals who will receive a placebo supplementation in the period of 16 weeks | Other: Placebo control<br>* The participants will receive a supplementation capsule containing placebo in the morning in single-dose capsules. The intervention will last 16 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Browning of white adipose tissue | Changes in the gene and protein expression on the subcutaneous white adipose tissue | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in metabolic parameters - fasting blood glucose | Changes in fasting blood glucose samples in pre and post intervention | 16 weeks | 
| Changes in metabolic parameters - lipid profile | Changes in lipid profile (total cholesterol, HDL-c, LDL-c, triglycerides)samples in pre and post intervention | 16 weeks | 
| Changes in metabolic parameters - insulin sensitivity | Changes in insulin sensitivity samples in pre and post intervention | 16 weeks | 
| Body composition changes | Changes in fat-free mass and fat mass evaluated pre and post intervention by iDEXA | 16 weeks | 
| Improvement of physical performance | Improvement of physical performance evaluated by the 6-minute walk test, elbow flexion, sit and stand test and hand grip test | 16 weeks | 
| Indirect calorimetry assessment | Changes in resting metabolic rate (RMR) evaluated pre and post intervention by indirect calorimetry. | 16 weeks | 
| Changes in inflamatory markers | Evaluate the inflamatory markers PCR, IL-1β, IL-6, IL-10, IL-15, IFNy, MCP1, TNF-α, NFκβ, JNK1, PTP1B, iNOS | 16 weeks | 
| Changes in subcutaneous white adipose tissue (sWAT) morphology | Evaluate the changes in the white adipose tissue morphology by the histological analysis | 16 weeks | 
| Changes in Lipidomic profile of sWAT | Evaluate the fatty acids profile in the sWAT | 16 weeks | 
| Changes in plasma taurine | Evaluate the changes in the plasma taurine pre and post intervention | 16 weeks | 
| Changes in plasma irisin | Evaluate the changes in plasma irisin pre and post intervention | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Sarcopenia, Brite adipose tissue, Taurine, Exercise