Taurine Supplementation Associated or Not With Exercise: Effect on Browning of White Adipose Tissue in Elderly Women With Sarcopenic Obesity
Primary Purpose
Browning of Subcutaneous White Adipose Tissue Post Intervention, Metabolic and Inflammatory Variables Post Intervention
Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Taurine supplementation
Pshysical exercise
Placebo control
Sponsored by
About this trial
This is an interventional treatment trial for Browning of Subcutaneous White Adipose Tissue Post Intervention focused on measuring Obesity, Sarcopenia, Brite adipose tissue, Taurine, Exercise
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)
Sites / Locations
- Escola de Educação Física e Esporte de Ribeirão Preto
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Taurine and Exercise (Tau+Exe)
Taurine (Tau)
Exercise (Exe)
Placebo (Cont)
Arm Description
Individuals who will receive 3g of taurine supplementation combined with physical training in the period of 16 weeks
Individuals who will receive 3g of taurine supplementation
Individuals who will perform a physical training and receive a placebo supplementation in the period of 16 weeks
Individuals who will receive a placebo supplementation in the period of 16 weeks
Outcomes
Primary Outcome Measures
Browning of white adipose tissue
Changes in the gene and protein expression on the subcutaneous white adipose tissue
Secondary Outcome Measures
Changes in metabolic parameters - fasting blood glucose
Changes in fasting blood glucose samples in pre and post intervention
Changes in metabolic parameters - lipid profile
Changes in lipid profile (total cholesterol, HDL-c, LDL-c, triglycerides)samples in pre and post intervention
Changes in metabolic parameters - insulin sensitivity
Changes in insulin sensitivity samples in pre and post intervention
Body composition changes
Changes in fat-free mass and fat mass evaluated pre and post intervention by iDEXA
Improvement of physical performance
Improvement of physical performance evaluated by the 6-minute walk test, elbow flexion, sit and stand test and hand grip test
Indirect calorimetry assessment
Changes in resting metabolic rate (RMR) evaluated pre and post intervention by indirect calorimetry.
Changes in inflamatory markers
Evaluate the inflamatory markers PCR, IL-1β, IL-6, IL-10, IL-15, IFNy, MCP1, TNF-α, NFκβ, JNK1, PTP1B, iNOS
Changes in subcutaneous white adipose tissue (sWAT) morphology
Evaluate the changes in the white adipose tissue morphology by the histological analysis
Changes in Lipidomic profile of sWAT
Evaluate the fatty acids profile in the sWAT
Changes in plasma taurine
Evaluate the changes in the plasma taurine pre and post intervention
Changes in plasma irisin
Evaluate the changes in plasma irisin pre and post intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05415176
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 27, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Browning of Subcutaneous White Adipose Tissue Post Intervention, Metabolic and Inflammatory Variables Post Intervention
Keywords
Obesity, Sarcopenia, Brite adipose tissue, Taurine, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Taurine and Exercise (Tau+Exe)
Arm Type
Experimental
Arm Description
Individuals who will receive 3g of taurine supplementation combined with physical training in the period of 16 weeks
Arm Title
Taurine (Tau)
Arm Type
Experimental
Arm Description
Individuals who will receive 3g of taurine supplementation
Arm Title
Exercise (Exe)
Arm Type
Experimental
Arm Description
Individuals who will perform a physical training and receive a placebo supplementation in the period of 16 weeks
Arm Title
Placebo (Cont)
Arm Type
Placebo Comparator
Arm Description
Individuals who will receive a placebo supplementation in the period of 16 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Taurine supplementation
Intervention Description
Participants will receive 3g of taurine to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks.
Intervention Type
Other
Intervention Name(s)
Pshysical exercise
Intervention Description
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
Intervention Name(s)
Placebo control
Intervention Description
The participants will receive a supplementation capsule containing placebo in the morning in single-dose capsules. The intervention will last 16 weeks.
Primary Outcome Measure Information:
Title
Browning of white adipose tissue
Description
Changes in the gene and protein expression on the subcutaneous white adipose tissue
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Changes in metabolic parameters - fasting blood glucose
Description
Changes in fasting blood glucose samples in pre and post intervention
Time Frame
16 weeks
Title
Changes in metabolic parameters - lipid profile
Description
Changes in lipid profile (total cholesterol, HDL-c, LDL-c, triglycerides)samples in pre and post intervention
Time Frame
16 weeks
Title
Changes in metabolic parameters - insulin sensitivity
Description
Changes in insulin sensitivity samples in pre and post intervention
Time Frame
16 weeks
Title
Body composition changes
Description
Changes in fat-free mass and fat mass evaluated pre and post intervention by iDEXA
Time Frame
16 weeks
Title
Improvement of physical performance
Description
Improvement of physical performance evaluated by the 6-minute walk test, elbow flexion, sit and stand test and hand grip test
Time Frame
16 weeks
Title
Indirect calorimetry assessment
Description
Changes in resting metabolic rate (RMR) evaluated pre and post intervention by indirect calorimetry.
Time Frame
16 weeks
Title
Changes in inflamatory markers
Description
Evaluate the inflamatory markers PCR, IL-1β, IL-6, IL-10, IL-15, IFNy, MCP1, TNF-α, NFκβ, JNK1, PTP1B, iNOS
Time Frame
16 weeks
Title
Changes in subcutaneous white adipose tissue (sWAT) morphology
Description
Evaluate the changes in the white adipose tissue morphology by the histological analysis
Time Frame
16 weeks
Title
Changes in Lipidomic profile of sWAT
Description
Evaluate the fatty acids profile in the sWAT
Time Frame
16 weeks
Title
Changes in plasma taurine
Description
Evaluate the changes in the plasma taurine pre and post intervention
Time Frame
16 weeks
Title
Changes in plasma irisin
Description
Evaluate the changes in plasma irisin pre and post intervention
Time Frame
16 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen C de Freitas, PhD
Organizational Affiliation
University of São Paulo, School of Physical Education and Sports of Ribeirão Preto Ph.D. +55 16 3602-0345 ellenfreitas@usp.br
Official's Role
Principal Investigator
Facility Information:
Facility Name
Escola de Educação Física e Esporte de Ribeirão Preto
City
Ribeirao Preto
State/Province
Sao Paulo
ZIP/Postal Code
14040-907
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Taurine Supplementation Associated or Not With Exercise: Effect on Browning of White Adipose Tissue in Elderly Women With Sarcopenic Obesity
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