Taurine Supplementation Associated or Not With Exercise: Effect on Browning of White Adipose Tissue in Elderly Women With Sarcopenic Obesity
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2022
CompletedFirst Posted
Study publicly available on registry
June 10, 2022
CompletedStudy Start
First participant enrolled
February 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedNovember 29, 2023
November 1, 2023
7 months
June 8, 2022
November 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Browning of white adipose tissue
Changes in the gene and protein expression on the subcutaneous white adipose tissue
16 weeks
Secondary Outcomes (11)
Changes in metabolic parameters - fasting blood glucose
16 weeks
Changes in metabolic parameters - lipid profile
16 weeks
Changes in metabolic parameters - insulin sensitivity
16 weeks
Body composition changes
16 weeks
Improvement of physical performance
16 weeks
- +6 more secondary outcomes
Study Arms (4)
Taurine and Exercise (Tau+Exe)
EXPERIMENTALIndividuals who will receive 3g of taurine supplementation combined with physical training in the period of 16 weeks
Taurine (Tau)
EXPERIMENTALIndividuals who will receive 3g of taurine supplementation
Exercise (Exe)
EXPERIMENTALIndividuals who will perform a physical training and receive a placebo supplementation in the period of 16 weeks
Placebo (Cont)
PLACEBO COMPARATORIndividuals who will receive a placebo supplementation in the period of 16 weeks
Interventions
Participants will receive 3g of taurine to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks.
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
The participants will receive a supplementation capsule containing placebo in the morning in single-dose capsules. The intervention will last 16 weeks.
Eligibility Criteria
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
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Escola de Educação Física e Esporte de Ribeirão Preto
Ribeirão Preto, São Paulo, 14040-907, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ellen C de Freitas, PhD
University of São Paulo, School of Physical Education and Sports of Ribeirão Preto Ph.D. +55 16 3602-0345 ellenfreitas@usp.br
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 8, 2022
First Posted
June 10, 2022
Study Start
February 27, 2023
Primary Completion
September 26, 2023
Study Completion
June 1, 2024
Last Updated
November 29, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share