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| Name | Class |
|---|---|
| Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. | OTHER_GOV |
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Taurine and Exercise (Tau+Ex) | Experimental | Participants who will receive 3g of taurine supplementation associated with physical training in the period of 16 weeks. |
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| Placebo and Exercise (PL+Ex) | Experimental | Participants who will receive 3g of placebo supplementation associated with physical training in the period of 16 weeks. |
|
| Taurine (Tau) | Experimental | Participants who will receive 3g of taurine supplementation in the period of 16 weeks. |
|
| Placebo (PL) | Placebo Comparator | Participants who will receive 3g of placebo supplementation in the period of 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taurine and Exercise (Tau+Ex) | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolomic Profile | Changes in metabolites and lipids of the biological sample investigated through the metabolomics approach. | 16 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriela F Abud, M.Sc. | Contact | +5516997940181 | gabriela.abud@usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Ellen C de Freitas, Ph.D. | University of São Paulo, School of Physical Education and Sports of Ribeirão Preto | Principal Investigator |
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Randomized, double-blind clinical trial
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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).
|
| Placebo and Exercise (PL+Ex) | Other | 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. |
|
| Taurine (Tau) | Dietary Supplement | Participants will receive 3g of taurine to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks. |
|
| Placebo (PL) | Other | Participants will receive 3g of placebo to be supplemented in the morning in single-dose capsules. The intervention will last 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 |
| ID | Term |
|---|---|
| D013654 | Taurine |
| D015444 | Exercise |
| D016875 | tau Proteins |
| ID | Term |
|---|---|
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D008869 | Microtubule-Associated Proteins |
| D008868 | Microtubule Proteins |
| D003598 | Cytoskeletal Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
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