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

NCT ID: NCT05437952

Last Updated: 2022-06-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-31
• Study Completion Date: 2022-12-31

Brief 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.

Detailed 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.

Conditions

Sarcopenic Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Taurine and Exercise (Tau+Ex)

Participants who will receive 3g of taurine supplementation associated with physical training in the period of 16 weeks.

Group Type: EXPERIMENTAL

Taurine and Exercise (Tau+Ex)

Intervention Type: 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

Placebo and Exercise (PL+Ex)

Participants who will receive 3g of placebo supplementation associated with physical training in the period of 16 weeks.

Group Type: EXPERIMENTAL

Placebo and Exercise (PL+Ex)

Intervention Type: 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)

Participants who will receive 3g of taurine supplementation in the period of 16 weeks.

Group Type: EXPERIMENTAL

Taurine (Tau)

Intervention Type: 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)

Participants who will receive 3g of placebo supplementation in the period of 16 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo (PL)

Intervention Type: OTHER

Participants will receive 3g of placebo to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks.

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

Taurine (Tau)

Participants will receive 3g of taurine to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Placebo (PL)

Participants will receive 3g of placebo to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role: collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Ellen Cristini de Freitas

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ellen C de Freitas, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of São Paulo, School of Physical Education and Sports of Ribeirão Preto

Central Contacts

Gabriela F Abud, M.Sc.

Role: CONTACT

gabriela.abud@usp.br

+5516997940181

Other Identifiers

taurine_training_metabolomics

Identifier Type: -

Identifier Source: org_study_id