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

NCT05437952 | Unknown

• 1 other identifier: taurine_training_metabolomics
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sarcopenic Obesity

Keywords

Sarcopenic Obesity; Aging; Taurine; Multicomponent Training; Metabolomics

Outcome Measures

Primary Outcomes (1)

• Metabolomic Profile

  Changes in metabolites and lipids of the biological sample investigated through the metabolomics approach.

  16 weeks

Secondary Outcomes (15)

• Gene expressions in the subcutaneous white adipose tissue (scWAT). RNA (mRNA) levels of infammatory gene markers.

  16 weeks

• Gene expressions in the subcutaneous white adipose tissue (scWAT). RNA (mRNA) levels of oxidative stress genes markers.

  16 weeks

• Gene expressions in the subcutaneous white adipose tissue (scWAT). RNA (mRNA) levels of lipid oxidation genes markers.

  16 weeks

• Functional ability tests: Six-minute walk test (minutes)

  16 weeks

• Functional ability tests: forearm flexion test (seconds)

  16 weeks

Study Arms (4)

Taurine and Exercise (Tau+Ex)

EXPERIMENTAL

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)

Placebo and Exercise (PL+Ex)

EXPERIMENTAL

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

Other: Placebo and Exercise (PL+Ex)

Taurine (Tau)

EXPERIMENTAL

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

Dietary Supplement: Taurine (Tau)

Placebo (PL)

PLACEBO COMPARATOR

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

Other: Placebo (PL)

Interventions

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

Taurine and Exercise (Tau+Ex)

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.

Placebo and Exercise (PL+Ex)

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.

Taurine (Tau)

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.

Placebo (PL)

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Sao Paulo: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

MeSH Terms

Interventions

Taurine; Exercise; tau Proteins

Intervention Hierarchy (Ancestors)

Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Microtubule-Associated Proteins; Microtubule Proteins; Cytoskeletal Proteins; Proteins; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins

Study Officials

• Ellen C de Freitas, Ph.D.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriela F Abud, M.Sc.

CONTACT

+5516997940181; gabriela.abud@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, double-blind clinical trial

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 29, 2022
• Study Start: July 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 29, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share