Metabolic and Molecular Responses Under the Effect of Taurine Supplementation With and Without Multicomponent Training

Study Overview
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Brief Summary
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Sarcopenic obesity is characterized by a progressive decline in muscle mass and an increase in body fat, a condition especially present in the elderly. A significant improvement in metabolic parameters has been observed with the completion of taurine supplementation and also with the practice of physical exercise, but there are no studies associating the interventions mentioned above with the aim of analyzing the metabolic profile of elderly people with sarcopenic obesity. The metabolomics approach allows the study of a whole set of metabolites involved in a biological system. It is believed that taurine supplementation associated with physical exercise is capable of promoting positive contributions to the metabolic profile, investigated through a metabolomics approach. Therefore, the present study seeks to investigate whether taurine supplementation associated with exercise is able to promote contributions to the metabolic profile, through a metabolomics approach, in elderly women with sarcopenic obesity.

Detailed Description
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Sarcopenic obesity is characterized by a progressive decline in muscle mass and an increase in body fat, a condition especially present in the elderly. A significant improvement in metabolic parameters has been observed with the completion of taurine supplementation and also with the practice of physical exercise, but there are no studies associating the interventions mentioned above with the aim of analyzing the metabolic profile of elderly people with sarcopenic obesity. The metabolomics approach allows the study of a whole set of metabolites involved in a biological system. It is believed that taurine supplementation associated with physical exercise is capable of promoting positive contributions to the metabolic profile, investigated through a metabolomics approach. The study will involve 60 elderly women with sarcopenic obesity who will be randomly distributed into 4 groups: 1) GPL, submitted to placebo supplementation (n=15); 2) GTAU, submitted to taurine supplementation (n=15); 3) GPL+EX, submitted to placebo supplementation associated with physical exercise (n=15) and 4) GTAU+EX, submitted to taurine supplementation associated with physical exercise (n=15). The interventions will take place for 16 weeks, collections and evaluations will be carried out pre and post-intervention of functional capacity testing, anthropometry, resting energy expenditure, biopsy of white adipose tissue for analysis of gene expression and blood collection for analysis of the plasma concentration of taurine and of the metabolomic profile. Body composition, and food consumption will be evaluated pre, during and post-intervention. The synergistic effects of the proposed intervention are expected to improve the metabolic parameters, regarding the profile anti-inflammatory, antioxidant, lipid metabolism, body composition, and functional physical capacity in elderly women with sarcopenic obesity.

Official Title
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Metabolic and Molecular Responses Under the Effect of Taurine Supplementation With and Without Multicomponent Training in Elderly Women With Sarcopenic Obesity Using the Metabolomics Approach

Conditions
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Sarcopenic Obesity

Intervention / Treatment
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* Dietary Supplement: Taurine and Exercise (Tau+Ex)
* Other: Placebo and Exercise (PL+Ex)
* Dietary Supplement: Taurine (Tau)
* Other: Placebo (PL)


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; with any disease 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), suggested by Bertolucci et al. (1994).

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, double-blind clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Taurine and Exercise (Tau+Ex)<br>Participants who will receive 3g of taurine supplementation associated with physical training in the period of 16 weeks. | Dietary Supplement: Taurine and Exercise (Tau+Ex)<br>* Participants will receive 3g of taurine to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks. Pshysical exercise 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: Placebo and Exercise (PL+Ex)<br>Participants who will receive 3g of placebo supplementation associated with physical training in the period of 16 weeks. | Other: Placebo and Exercise (PL+Ex)<br>* Participants will receive 3g of placebo to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks. Pshysical exercise 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>Participants who will receive 3g of taurine supplementation in the period of 16 weeks. | Dietary Supplement: Taurine (Tau)<br>* Participants will receive 3g of taurine to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks.<br>|
| Placebo Comparator: Placebo (PL)<br>Participants who will receive 3g of placebo supplementation in the period of 16 weeks. | Other: Placebo (PL)<br>* Participants will receive 3g of placebo to be supplemented 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 |
| --- | --- | --- |
| Metabolomic Profile | Changes in metabolites and lipids of the biological sample investigated through the metabolomics approach. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene expressions in the subcutaneous white adipose tissue (scWAT). RNA (mRNA) levels of infammatory gene markers. | Changes in the expression of genes related to the inflammatory process that will be analyzed: C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-10 (IL-10), interleukin-15 (IL-15), necrosis factor tumor-α (TNF-α), nuclear factor-κβ (NFκβ) and adiponectin (ADIPOQ). | 16 weeks | 
| Gene expressions in the subcutaneous white adipose tissue (scWAT). RNA (mRNA) levels of oxidative stress genes markers. | Changes in the expression of genes related to oxidative stress that will be analyzed: superoxide dismutase (SOD1), glutathione peroxidase (GPx1) and catalase (CAT). | 16 weeks | 
| Gene expressions in the subcutaneous white adipose tissue (scWAT). RNA (mRNA) levels of lipid oxidation genes markers. | Changes expression of genes related to the lipid oxidation process that will be analyzed: sirtuin-1 (SIRT-1), forkhead O 1 (FOXO1), peroxisome proliferator 1 alpha (PGC-1α), peroxisomal proliferator alpha type (PPARα). | 16 weeks | 
| Functional ability tests: Six-minute walk test (minutes) | Changes in functional capacity assessed by: six-minute walk test. | 16 weeks | 
| Functional ability tests: forearm flexion test (seconds) | Changes in functional capacity assessed by: forearm flexion test. | 16 weeks | 
| Functional ability tests: muscle strength (dynamometer) - highest peak force (KGF) | Changes in functional capacity assessed by: muscle strength (dynamometer). | 16 weeks | 
| Functional ability tests: chair sit-up test. (seconds) | Changes in functional capacity assessed by: chair sit-up test. | 16 weeks | 
| Indirect calorimetry assessment | Changes in resting metabolic rate (RMR) evaluated pre and post intervention by indirect calorimetry. | 16 weeks | 
| Body composition changes (%) | Changes in % fat-free mass and fat mass evaluated pre, during and post intervention by iDEXA. | 16 weeks | 
| Anthropometric measurements (Body weight) | Changes in body weight (kilograms - Kg) pre and post intervention. | 16 weeks | 
| Anthropometric - height assessment (meters) | Height measured in meters | 16 weeks | 
| Anthropometric measurements (Circumferences) | Changes in waist, abdominal, and hip circumferences (centimeters) evaluated pre and post intervention. | 16 weeks | 
| Others changes in metabolic parameters | Changes in total cholesterol, triglycerides, HDL-cholesterol and LDL-c, fasting glucose and insulin sensitivity evaluated pre and post intervention. | 16 weeks | 
| Food Intake changes | Changes in food consumption. It will be evaluated through 24-hour food records. The professional software Dietbox will be used to evaluate the total consumption of energy and macronutrients. Evaluated pre, during and post intervention. | 16 weeks | 
| Changes in Plasma Taurine Concentration | Changes in Plasma Taurine Concentration. Plasma taurine will be determined by high performance liquid chromatography (HPLC). | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcopenic Obesity, Aging, Taurine, Multicomponent Training, Metabolomics