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

Sarcopenic Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05437952
• Other study ID #: taurine_training_metabolomics
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2022
• Est. completion date: December 2022

Study information

• Verified date: June 2022
• Source: University of Sao Paulo
• Contact: Gabriela F Abud, M.Sc.
• Phone: +5516997940181
• Email: gabriela.abud[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Obesity
• Sarcopenic Obesity

Intervention

Dietary Supplement:
• Taurine and Exercise (Tau+Ex)
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

Other:
• Placebo and Exercise (PL+Ex)
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.

Dietary Supplement:
• Taurine (Tau)
Participants will receive 3g of taurine to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks.

Other:
• Placebo (PL)
Participants will receive 3g of placebo to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do Estado de São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolomic Profile	Changes in metabolites and lipids of the biological sample investigated through the metabolomics approach.	16 weeks
Secondary	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-a (TNF-a), nuclear factor-?ß (NF?ß) and adiponectin (ADIPOQ).	16 weeks
Secondary	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
Secondary	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-1a), peroxisomal proliferator alpha type (PPARa).	16 weeks
Secondary	Functional ability tests: Six-minute walk test (minutes)	Changes in functional capacity assessed by: six-minute walk test.	16 weeks
Secondary	Functional ability tests: forearm flexion test (seconds)	Changes in functional capacity assessed by: forearm flexion test.	16 weeks
Secondary	Functional ability tests: muscle strength (dynamometer) - highest peak force (KGF)	Changes in functional capacity assessed by: muscle strength (dynamometer).	16 weeks
Secondary	Functional ability tests: chair sit-up test. (seconds)	Changes in functional capacity assessed by: chair sit-up test.	16 weeks
Secondary	Indirect calorimetry assessment	Changes in resting metabolic rate (RMR) evaluated pre and post intervention by indirect calorimetry.	16 weeks
Secondary	Body composition changes (%)	Changes in % fat-free mass and fat mass evaluated pre, during and post intervention by iDEXA.	16 weeks
Secondary	Anthropometric measurements (Body weight)	Changes in body weight (kilograms - Kg) pre and post intervention.	16 weeks
Secondary	Anthropometric - height assessment (meters)	Height measured in meters	16 weeks
Secondary	Anthropometric measurements (Circumferences)	Changes in waist, abdominal, and hip circumferences (centimeters) evaluated pre and post intervention.	16 weeks
Secondary	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
Secondary	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
Secondary	Changes in Plasma Taurine Concentration	Changes in Plasma Taurine Concentration. Plasma taurine will be determined by high performance liquid chromatography (HPLC).	16 weeks