- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05415176
Taurine Supplementation Associated or Not With Exercise: Effect on Browning of White Adipose Tissue in Elderly Women With Sarcopenic Obesity
November 28, 2023 updated by: Ellen Cristini de Freitas, University of Sao Paulo
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gabriela U Ortiz, Bachelor
- Phone Number: +5516991461389
- Email: gabrielaueortiz@gmail.com
Study Locations
-
-
Sao Paulo
-
Ribeirao Preto, Sao Paulo, Brazil, 14040-907
- Escola de Educação Física e Esporte de Ribeirão Preto
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Taurine and Exercise (Tau+Exe)
Individuals who will receive 3g of taurine supplementation combined with physical training in the period of 16 weeks
|
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
|
Experimental: Taurine (Tau)
Individuals who will receive 3g of taurine supplementation
|
Participants will receive 3g of taurine to be supplemented in the morning in single-dose capsules.
The intervention will last 16 weeks.
|
Experimental: Exercise (Exe)
Individuals who will perform a physical training and receive a placebo supplementation in the period of 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
|
Placebo Comparator: Placebo (Cont)
Individuals who will receive a placebo supplementation in the period of 16 weeks
|
The participants will receive a supplementation capsule containing placebo in the morning in single-dose capsules.
The intervention will last 16 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Browning of white adipose tissue
Time Frame: 16 weeks
|
Changes in the gene and protein expression on the subcutaneous white adipose tissue
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Indirect calorimetry assessment
Time Frame: 16 weeks
|
Changes in resting metabolic rate (RMR) evaluated pre and post intervention by indirect calorimetry.
|
16 weeks
|
Changes in metabolic parameters - fasting blood glucose
Time Frame: 16 weeks
|
Changes in fasting blood glucose samples in pre and post intervention
|
16 weeks
|
Changes in metabolic parameters - lipid profile
Time Frame: 16 weeks
|
Changes in lipid profile (total cholesterol, HDL-c, LDL-c, triglycerides)samples in pre and post intervention
|
16 weeks
|
Changes in metabolic parameters - insulin sensitivity
Time Frame: 16 weeks
|
Changes in insulin sensitivity samples in pre and post intervention
|
16 weeks
|
Body composition changes
Time Frame: 16 weeks
|
Changes in fat-free mass and fat mass evaluated pre and post intervention by iDEXA
|
16 weeks
|
Improvement of physical performance
Time Frame: 16 weeks
|
Improvement of physical performance evaluated by the 6-minute walk test, elbow flexion, sit and stand test and hand grip test
|
16 weeks
|
Changes in inflamatory markers
Time Frame: 16 weeks
|
Evaluate the inflamatory markers PCR, IL-1β, IL-6, IL-10, IL-15, IFNy, MCP1, TNF-α, NFκβ, JNK1, PTP1B, iNOS
|
16 weeks
|
Changes in subcutaneous white adipose tissue (sWAT) morphology
Time Frame: 16 weeks
|
Evaluate the changes in the white adipose tissue morphology by the histological analysis
|
16 weeks
|
Changes in Lipidomic profile of sWAT
Time Frame: 16 weeks
|
Evaluate the fatty acids profile in the sWAT
|
16 weeks
|
Changes in plasma taurine
Time Frame: 16 weeks
|
Evaluate the changes in the plasma taurine pre and post intervention
|
16 weeks
|
Changes in plasma irisin
Time Frame: 16 weeks
|
Evaluate the changes in plasma irisin pre and post intervention
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 27, 2023
Primary Completion (Actual)
September 26, 2023
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
June 8, 2022
First Submitted That Met QC Criteria
June 8, 2022
First Posted (Actual)
June 10, 2022
Study Record Updates
Last Update Posted (Actual)
November 29, 2023
Last Update Submitted That Met QC Criteria
November 28, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Taurine_exercise_browning
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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