Browning of Subcutaneous White Adipose Tissue Post InterventionNCT05415176
Taurine Supplementation Associated or Not With Exercise: Effect on Browning of White Adipose Tissue in Elderly Women With Sarcopenic Obesity
A study testing Taurine supplementation and Pshysical exercise in people with Browning of Subcutaneous White Adipose Tissue Post Intervention and Metabolic and Inflammatory Variables Post Intervention, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women only
- Conditions the study is for
- Browning of Subcutaneous White Adipose Tissue Post Intervention, Metabolic and Inflammatory Variables Post Intervention
- What is being tested?
- Taurine supplementation and Pshysical exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Feb 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- chronic kidney diseases
- undergoing nutritional monitoring or weight loss treatment
- score ≤13 for cognitive screening on the Mini-Mental State Examination (MMSE)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Escola de Educação Física e Esporte de Ribeirão Preto
Ribeirão Preto, São Paulo, 14040-907
About this study
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.
Read the 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.
- Conditions
- Browning of Subcutaneous White Adipose Tissue Post Intervention, Metabolic and Inflammatory Variables Post Intervention
- Being tested
- Taurine supplementation, Pshysical exercise, Placebo control
- Keywords
- Obesity, Sarcopenia, Brite adipose tissue, Taurine, Exercise
- Medical subject headings
- Obesity, Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taurine supplementationDietary supplement
Participants will receive 3g of taurine to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks.
Pshysical exerciseOther
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 controlOther
The participants will receive a supplementation capsule containing placebo in the morning in single-dose capsules. The intervention will last 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Taurine and Exercise (Tau+Exe) | Experimental | Individuals who will receive 3g of taurine supplementation combined with physical training in the period of 16 weeks Receives: Dietary Supplement: Taurine supplementation; Other: Pshysical exercise |
| Taurine (Tau) | Experimental | Individuals who will receive 3g of taurine supplementation Receives: Dietary Supplement: Taurine supplementation |
| Exercise (Exe) | Experimental | Individuals who will perform a physical training and receive a placebo supplementation in the period of 16 weeks Receives: Other: Pshysical exercise |
| Placebo (Cont) | Placebo comparator | Individuals who will receive a placebo supplementation in the period of 16 weeks Receives: Other: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Browning of white adipose tissue
Changes in the gene and protein expression on the subcutaneous white adipose tissue
Measured: 16 weeks
Secondary outcomes (11)
Changes in metabolic parameters - fasting blood glucose
Changes in fasting blood glucose samples in pre and post intervention
Measured: 16 weeks
Changes in metabolic parameters - lipid profile
Changes in lipid profile (total cholesterol, HDL-c, LDL-c, triglycerides)samples in pre and post intervention
Measured: 16 weeks
Changes in metabolic parameters - insulin sensitivity
Changes in insulin sensitivity samples in pre and post intervention
Measured: 16 weeks
Body composition changes
Changes in fat-free mass and fat mass evaluated pre and post intervention by iDEXA
Measured: 16 weeks
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
Measured: 16 weeks
Indirect calorimetry assessment
Changes in resting metabolic rate (RMR) evaluated pre and post intervention by indirect calorimetry.
Measured: 16 weeks
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
Measured: 16 weeks
Changes in subcutaneous white adipose tissue (sWAT) morphology
Evaluate the changes in the white adipose tissue morphology by the histological analysis
Measured: 16 weeks
Changes in Lipidomic profile of sWAT
Evaluate the fatty acids profile in the sWAT
Measured: 16 weeks
Changes in plasma taurine
Evaluate the changes in the plasma taurine pre and post intervention
Measured: 16 weeks
Changes in plasma irisin
Evaluate the changes in plasma irisin pre and post intervention
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start27 Feb 2023
- Primary completion26 Sep 2023
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Browning of Subcutaneous White Adipose Tissue Post InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen Cristini de Freitas, University of Sao Paulo
- Investigators
- Ellen C de Freitas, PhD, Principal investigator, University of São Paulo, School of Physical Education and Sports of Ribeirão Preto Ph.D. +55 16 3602-0345 ellenfreitas@usp.br
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415176
- Sponsor's protocol ID
- Taurine_exercise_browning
- Status last verified
- Nov 2023
- First submitted
- 8 Jun 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taurine Supplementation Associated or Not With Exercise: Effect on Browning of White Adipose Tissue in Elderly Women With Sarcopenic Obesity
- ClinicalTrials.gov ID
- NCT05415176
- Acronym / sponsor ID
- Taurine_exercise_browning
- Conditions
- Browning of Subcutaneous White Adipose Tissue Post Intervention, Metabolic and Inflammatory Variables Post Intervention
- Keywords
- Obesity, Sarcopenia, Brite adipose tissue, Taurine, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 10 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Taurine and Exercise (Tau+Exe) | Experimental | Dietary Supplement: Taurine supplementation, Other: Pshysical exerciseIndividuals who will receive 3g of taurine supplementation combined with physical training in the period of 16 weeks |
| Taurine (Tau) | Experimental | Dietary Supplement: Taurine supplementationIndividuals who will receive 3g of taurine supplementation |
| Exercise (Exe) | Experimental | Other: Pshysical exerciseIndividuals who will perform a physical training and receive a placebo supplementation in the period of 16 weeks |
| Placebo (Cont) | Placebo comparator | Other: Placebo controlIndividuals who will receive a placebo supplementation in the period of 16 weeks |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- alcoholics
- smokers
- diseases that prevents the practice of physical activity
- medical impediment to the practice of physical exercise throughout the study
- infectious diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taurine supplementationParticipants will receive 3g of taurine to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks. | Dietary supplement | Taurine (Tau), Taurine and Exercise (Tau+Exe) |
| Pshysical exerciseParticipants 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 | Other | Exercise (Exe), Taurine and Exercise (Tau+Exe) |
| Placebo controlThe participants will receive a supplementation capsule containing placebo in the morning in single-dose capsules. The intervention will last 16 weeks. | Other | Placebo (Cont) |
Primary outcome
Browning of white adipose tissue
Time frame: 16 weeks
Changes in the gene and protein expression on the subcutaneous white adipose tissue
11 secondary outcomes
Changes in metabolic parameters - fasting blood glucose
Time frame: 16 weeks
Changes in metabolic parameters - lipid profile
Time frame: 16 weeks
Changes in metabolic parameters - insulin sensitivity
Time frame: 16 weeks
Body composition changes
Time frame: 16 weeks
Improvement of physical performance
Time frame: 16 weeks
Indirect calorimetry assessment
Time frame: 16 weeks
Changes in inflamatory markers
Time frame: 16 weeks
Changes in subcutaneous white adipose tissue (sWAT) morphology
Time frame: 16 weeks
Changes in Lipidomic profile of sWAT
Time frame: 16 weeks
Changes in plasma taurine
Time frame: 16 weeks
Changes in plasma irisin
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen C de Freitas, PhD principal investigator
University of São Paulo, School of Physical Education and Sports of Ribeirão Preto Ph.D. +55 16 3602-0345 ellenfreitas@usp.br
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taurine supplementation and Pshysical exercise in people with Browning of Subcutaneous White Adipose Tissue Post Intervention and Metabolic and Inflammatory Variables Post Intervention, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Browning of white adipose tissue (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.