Clinical trial NCT05437952: Metabolic and Molecular Responses Under the Effect of Taurine Supplementation With and Without Multicomponent Training
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenic Obesity
Keywords: Sarcopenic Obesity
Aging
Taurine
Multicomponent Training
Metabolomics
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2022-06-29
Enrollment: 60
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind clinical trial
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Metabolomic Profile
timeFrame: 16 weeks
Secondary outcomes:
measure: Gene expressions in the subcutaneous white adipose tissue (scWAT). RNA (mRNA) levels of infammatory gene markers.
timeFrame: 16 weeks
measure: Gene expressions in the subcutaneous white adipose tissue (scWAT). RNA (mRNA) levels of oxidative stress genes markers.
timeFrame: 16 weeks
measure: Gene expressions in the subcutaneous white adipose tissue (scWAT). RNA (mRNA) levels of lipid oxidation genes markers.
timeFrame: 16 weeks
measure: Functional ability tests: Six-minute walk test (minutes)
timeFrame: 16 weeks
measure: Functional ability tests: forearm flexion test (seconds)
timeFrame: 16 weeks
measure: Functional ability tests: muscle strength (dynamometer) - highest peak force (KGF)
timeFrame: 16 weeks
measure: Functional ability tests: chair sit-up test. (seconds)
timeFrame: 16 weeks
measure: Indirect calorimetry assessment
timeFrame: 16 weeks
measure: Body composition changes (%)
timeFrame: 16 weeks
measure: Anthropometric measurements (Body weight)
timeFrame: 16 weeks
measure: Anthropometric - height assessment (meters)
timeFrame: 16 weeks
measure: Anthropometric measurements (Circumferences)
timeFrame: 16 weeks
measure: Others changes in metabolic parameters
timeFrame: 16 weeks
measure: Food Intake changes
timeFrame: 16 weeks
measure: Changes in Plasma Taurine Concentration
timeFrame: 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of São Paulo, School of Physical Education and Sports of Ribeirão Preto
name: Ellen C de Freitas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: