Clinical trial NCT05415176: Taurine Supplementation Associated or Not With Exercise: Effect on Browning of White Adipose Tissue in Elderly Women With Sarcopenic Obesity
Official title: Taurine Supplementation Associated or Not With Exercise: Effect on Browning of White Adipose Tissue in Elderly Women With Sarcopenic Obesity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Browning of Subcutaneous White Adipose Tissue Post Intervention
Metabolic and Inflammatory Variables Post Intervention
Keywords: Obesity
Sarcopenia
Brite adipose tissue
Taurine
Exercise
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 40
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 clinical trial.
Primary purpose: TREATMENT

Brief summary: The aging process is followed by metabolic and body composition changes, increasing the risk of obesity and sarcopenia. The coexistence of these conditions acts synergistically on each other and is known as sarcopenic obesity. Beige adipose tissue is a tissue type that emerges from subcutaneous white adipose tissue (WAT), altering its phenotype to resemble the thermogenic functions of brown adipose tissue (BAT) in response to beta-adrenergic stimuli. Some in vitro and animal studies suggest that taurine supplementation and physical exercise are effective interventions in stimulating the aforementioned tissue, promoting what is known as WAT darkening, improving energy metabolism and showing benefits on the maintenance of muscle mass via stimulation of the coactivating protein PGC1α. These investigations are scarce in humans and could help health professionals in the adjuvant treatment of sarcopenic obesity. Therefore, the aim of the present study is to analyze the effects of taurine supplementation associated or not with physical exercise on the darkening of the WAT in sarcopenic obese elderly women.

Detailed description: The aging process is followed by metabolic and body composition changes, increasing the risk of obesity and sarcopenia. The coexistence of these conditions acts synergistically on each other and is known as sarcopenic obesity. Beige adipose tissue is a tissue type that emerges from subcutaneous white adipose tissue (WAT), altering its phenotype to resemble the thermogenic functions of brown adipose tissue (BAT) in response to beta-adrenergic stimuli. Some in vitro and animal studies suggest that taurine supplementation and physical exercise are effective interventions in stimulating the aforementioned tissue, promoting what is known as WAT darkening, improving energy metabolism and showing benefits on the maintenance of muscle mass via stimulation of the coactivating protein PGC1α. These investigations are scarce in humans and could help health professionals in the adjuvant treatment of sarcopenic obesity. Therefore, the aim of the present study is to analyze the effects of taurine supplementation associated or not with physical exercise on the darkening of the WAT in sarcopenic obese elderly women. Volunteers with low appendicular lean mass (\<15 kg) and body mass index (BMI) between 30 and 40 kg/m² will be recruited. These will be subdivided into 4 groups: control group (Cont), taurine (Tau), exercise (Exe) and exercise and taurine (Exe +Tau) and the duration of the intervention for all groups will be 16 weeks. Data related to anthropometry, body composition, biochemical tests, and food intake will be collected. To evaluate the effects on the darkening, a biopsy of the abdominal subcutaneous white adipose tissue will be performed to analyze protein, lipidomic and genetic parameters of this tissue pre and post intervention. Data will be analyzed by Analysis of Variance (ANOVA) or Kruskal-Wallis test depending on the normality of the data that will be tested by Shapiro-Wilk. A significance level for p \<0.05 will be admitted. All analyzes will be performed in SPSS version 20 software.

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
* diseases 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)

Primary outcomes:
measure: Browning of white adipose tissue
timeFrame: 16 weeks
Secondary outcomes:
measure: Changes in metabolic parameters - fasting blood glucose
timeFrame: 16 weeks
measure: Changes in metabolic parameters - lipid profile
timeFrame: 16 weeks
measure: Changes in metabolic parameters - insulin sensitivity
timeFrame: 16 weeks
measure: Body composition changes
timeFrame: 16 weeks
measure: Improvement of physical performance
timeFrame: 16 weeks
measure: Indirect calorimetry assessment
timeFrame: 16 weeks
measure: Changes in inflamatory markers
timeFrame: 16 weeks
measure: Changes in subcutaneous white adipose tissue (sWAT) morphology
timeFrame: 16 weeks
measure: Changes in Lipidomic profile of sWAT
timeFrame: 16 weeks
measure: Changes in plasma taurine
timeFrame: 16 weeks
measure: Changes in plasma irisin
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: Escola de Educação Física e Esporte de Ribeirão Preto
state: Sao Paulo
Study officials:
affiliation: University of São Paulo, School of Physical Education and Sports of Ribeirão Preto Ph.D. +55 16 3602-0345 ellenfreitas@usp.br
name: Ellen C de Freitas, PhD
role: PRINCIPAL_INVESTIGATOR
References: