Sarcopenic ObesityNCT05437952
Metabolic and Molecular Responses Under the Effect of Taurine Supplementation With and Without Multicomponent Training
A study testing Taurine and Exercise (Tau+Ex) and Taurine (Tau) in people with Sarcopenic Obesity, run by University of Sao Paulo.
Trial summary
Sarcopenic obesity is characterized by a progressive decline in muscle mass and an increase in body fat, a condition especially present in the elderly. A significant improvement in metabolic parameters has been observed with the completion of taurine supplementation and also with the practice of physical exercise, but… Read more about this study
- Who is it for?
- Ages 60 to 75 years, women only
- Conditions the study is for
- Sarcopenic Obesity
- What is being tested?
- Taurine and Exercise (Tau+Ex) and Taurine (Tau)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Dec 2022
- 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;
- with any disease that prevents the practice of physical activity;
- medical impediment to the practice of physical exercise throughout the study;
- infectious diseases;
- coronary diseases;
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- chronic kidney diseases;
- undergoing nutritional monitoring or weight loss treatment;
- score ≤13 for cognitive screening on the Mini-Mental State Examination (MMSE), suggested by Bertolucci et al. (1994).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Metabolic and Molecular Responses Under the Effect of Taurine Supplementation With and Without Multicomponent Training in Elderly Women With Sarcopenic Obesity Using the Metabolomics Approach
Sarcopenic obesity is characterized by a progressive decline in muscle mass and an increase in body fat, a condition especially present in the elderly. A significant improvement in metabolic parameters has been observed with the completion of taurine supplementation and also with the practice of physical exercise, but there are no studies associating the interventions mentioned above with the aim of analyzing the metabolic profile of elderly people with sarcopenic obesity. The metabolomics approach allows the study of a whole set of metabolites involved in a biological system. It is believed that taurine supplementation associated with physical exercise is capable of promoting positive contributions to the metabolic profile, investigated through a metabolomics approach. Therefore, the present study seeks to investigate whether taurine supplementation associated with exercise is able to promote contributions to the metabolic profile, through a metabolomics approach, in elderly women with sarcopenic obesity.
Read the detailed description
Sarcopenic obesity is characterized by a progressive decline in muscle mass and an increase in body fat, a condition especially present in the elderly. A significant improvement in metabolic parameters has been observed with the completion of taurine supplementation and also with the practice of physical exercise, but there are no studies associating the interventions mentioned above with the aim of analyzing the metabolic profile of elderly people with sarcopenic obesity. The metabolomics approach allows the study of a whole set of metabolites involved in a biological system. It is believed that taurine supplementation associated with physical exercise is capable of promoting positive contributions to the metabolic profile, investigated through a metabolomics approach. The study will involve 60 elderly women with sarcopenic obesity who will be randomly distributed into 4 groups: 1) GPL, submitted to placebo supplementation (n=15); 2) GTAU, submitted to taurine supplementation (n=15); 3) GPL+EX, submitted to placebo supplementation associated with physical exercise (n=15) and 4) GTAU+EX, submitted to taurine supplementation associated with physical exercise (n=15). The interventions will take place for 16 weeks, collections and evaluations will be carried out pre and post-intervention of functional capacity testing, anthropometry, resting energy expenditure, biopsy of white adipose tissue for analysis of gene expression and blood collection for analysis of the plasma concentration of taurine and of the metabolomic profile. Body composition, and food consumption will be evaluated pre, during and post-intervention. The synergistic effects of the proposed intervention are expected to improve the metabolic parameters, regarding the profile anti-inflammatory, antioxidant, lipid metabolism, body composition, and functional physical capacity in elderly women with sarcopenic obesity.
- Conditions
- Sarcopenic Obesity
- Being tested
- Taurine and Exercise (Tau+Ex), Placebo and Exercise (PL+Ex), Taurine (Tau), Placebo (PL)
- Keywords
- Sarcopenic Obesity, Aging, Taurine, Multicomponent Training, Metabolomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taurine and Exercise (Tau+Ex)Dietary supplement
Participants will receive 3g of taurine to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks.
Pshysical exercise
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 and Exercise (PL+Ex)Other
Participants will receive 3g of placebo to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks.
Pshysical exercise
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.
Taurine (Tau)Dietary supplement
Participants will receive 3g of taurine to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks.
Placebo (PL)Other
Participants will receive 3g of placebo to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Taurine and Exercise (Tau+Ex) | Experimental | Participants who will receive 3g of taurine supplementation associated with physical training in the period of 16 weeks. Receives: Dietary Supplement: Taurine and Exercise (Tau+Ex) |
| Placebo and Exercise (PL+Ex) | Experimental | Participants who will receive 3g of placebo supplementation associated with physical training in the period of 16 weeks. Receives: Other: Placebo and Exercise (PL+Ex) |
| Taurine (Tau) | Experimental | Participants who will receive 3g of taurine supplementation in the period of 16 weeks. Receives: Dietary Supplement: Taurine (Tau) |
| Placebo (PL) | Placebo comparator | Participants who will receive 3g of placebo supplementation in the period of 16 weeks. Receives: Other: Placebo (PL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolomic Profile
Changes in metabolites and lipids of the biological sample investigated through the metabolomics approach.
Measured: 16 weeks
Secondary outcomes (15)
Gene expressions in the subcutaneous white adipose tissue (scWAT). RNA (mRNA) levels of infammatory gene markers.
Changes in the expression of genes related to the inflammatory process that will be analyzed: C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-10 (IL-10), interleukin-15 (IL-15), necrosis factor tumor-α (TNF-α), nuclear factor-κβ (NFκβ) and adiponectin (ADIPOQ).
Measured: 16 weeks
Gene expressions in the subcutaneous white adipose tissue (scWAT). RNA (mRNA) levels of oxidative stress genes markers.
Changes in the expression of genes related to oxidative stress that will be analyzed: superoxide dismutase (SOD1), glutathione peroxidase (GPx1) and catalase (CAT).
Measured: 16 weeks
Gene expressions in the subcutaneous white adipose tissue (scWAT). RNA (mRNA) levels of lipid oxidation genes markers.
Changes expression of genes related to the lipid oxidation process that will be analyzed: sirtuin-1 (SIRT-1), forkhead O 1 (FOXO1), peroxisome proliferator 1 alpha (PGC-1α), peroxisomal proliferator alpha type (PPARα).
Measured: 16 weeks
Functional ability tests: Six-minute walk test (minutes)
Changes in functional capacity assessed by: six-minute walk test.
Measured: 16 weeks
Functional ability tests: forearm flexion test (seconds)
Changes in functional capacity assessed by: forearm flexion test.
Measured: 16 weeks
Functional ability tests: muscle strength (dynamometer) - highest peak force (KGF)
Changes in functional capacity assessed by: muscle strength (dynamometer).
Measured: 16 weeks
Functional ability tests: chair sit-up test. (seconds)
Changes in functional capacity assessed by: chair sit-up test.
Measured: 16 weeks
Indirect calorimetry assessment
Changes in resting metabolic rate (RMR) evaluated pre and post intervention by indirect calorimetry.
Measured: 16 weeks
Body composition changes (%)
Changes in % fat-free mass and fat mass evaluated pre, during and post intervention by iDEXA.
Measured: 16 weeks
Anthropometric measurements (Body weight)
Changes in body weight (kilograms - Kg) pre and post intervention.
Measured: 16 weeks
Anthropometric - height assessment (meters)
Height measured in meters
Measured: 16 weeks
Anthropometric measurements (Circumferences)
Changes in waist, abdominal, and hip circumferences (centimeters) evaluated pre and post intervention.
Measured: 16 weeks
Others changes in metabolic parameters
Changes in total cholesterol, triglycerides, HDL-cholesterol and LDL-c, fasting glucose and insulin sensitivity evaluated pre and post intervention.
Measured: 16 weeks
Food Intake changes
Changes in food consumption. It will be evaluated through 24-hour food records. The professional software Dietbox will be used to evaluate the total consumption of energy and macronutrients. Evaluated pre, during and post intervention.
Measured: 16 weeks
Changes in Plasma Taurine Concentration
Changes in Plasma Taurine Concentration. Plasma taurine will be determined by high performance liquid chromatography (HPLC).
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 posted29 Jun 2022
- Study startJul 2022 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenic ObesityStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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, double-blind clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Ellen Cristini de Freitas, University of Sao Paulo
- Investigators
- Ellen C de Freitas, Ph.D., Principal investigator, University of São Paulo, School of Physical Education and Sports of Ribeirão Preto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437952
- Sponsor's protocol ID
- taurine_training_metabolomics
- Status last verified
- Jun 2022
- First submitted
- 16 Jun 2022
- Last updated
- 29 Jun 2022
- 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 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic and Molecular Responses Under the Effect of Taurine Supplementation With and Without Multicomponent Training in Elderly Women With Sarcopenic Obesity Using the Metabolomics Approach
- ClinicalTrials.gov ID
- NCT05437952
- Acronym / sponsor ID
- taurine_training_metabolomics
- Conditions
- Sarcopenic Obesity
- Keywords
- Sarcopenic Obesity, Aging, Taurine, Multicomponent Training, Metabolomics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jul 2022 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 29 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.
Sarcopenic obesity is characterized by a progressive decline in muscle mass and an increase in body fat, a condition especially present in the elderly. A significant improvement in metabolic parameters has been observed with the completion of taurine supplementation and also with the practice of physical exercise, but there are no studies associating the interventions mentioned above with the aim of analyzing the metabolic profile of elderly people with sarcopenic obesity. The metabolomics approach allows the study of a whole set of metabolites involved in a biological system. It is believed that taurine supplementation associated with physical exercise is capable of promoting positive contributions to the metabolic profile, investigated through a metabolomics approach. Therefore, the present study seeks to investigate whether taurine supplementation associated with exercise is able to promote contributions to the metabolic profile, through a metabolomics approach, in elderly women with sarcopenic obesity.
Detailed description
Sarcopenic obesity is characterized by a progressive decline in muscle mass and an increase in body fat, a condition especially present in the elderly. A significant improvement in metabolic parameters has been observed with the completion of taurine supplementation and also with the practice of physical exercise, but there are no studies associating the interventions mentioned above with the aim of analyzing the metabolic profile of elderly people with sarcopenic obesity. The metabolomics approach allows the study of a whole set of metabolites involved in a biological system. It is believed that taurine supplementation associated with physical exercise is capable of promoting positive contributions to the metabolic profile, investigated through a metabolomics approach. The study will involve 60 elderly women with sarcopenic obesity who will be randomly distributed into 4 groups: 1) GPL, submitted to placebo supplementation (n=15); 2) GTAU, submitted to taurine supplementation (n=15); 3) GPL+EX, submitted to placebo supplementation associated with physical exercise (n=15) and 4) GTAU+EX, submitted to taurine supplementation associated with physical exercise (n=15). The interventions will take place for 16 weeks, collections and evaluations will be carried out pre and post-intervention of functional capacity testing, anthropometry, resting energy expenditure, biopsy of white adipose tissue for analysis of gene expression and blood collection for analysis of the plasma concentration of taurine and of the metabolomic profile. Body composition, and food consumption will be evaluated pre, during and post-intervention. The synergistic effects of the proposed intervention are expected to improve the metabolic parameters, regarding the profile anti-inflammatory, antioxidant, lipid metabolism, body composition, and functional physical capacity in elderly women with sarcopenic obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Randomized, double-blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| Taurine and Exercise (Tau+Ex) | Experimental | Dietary Supplement: Taurine and Exercise (Tau+Ex)Participants who will receive 3g of taurine supplementation associated with physical training in the period of 16 weeks. |
| Placebo and Exercise (PL+Ex) | Experimental | Other: Placebo and Exercise (PL+Ex)Participants who will receive 3g of placebo supplementation associated with physical training in the period of 16 weeks. |
| Taurine (Tau) | Experimental | Dietary Supplement: Taurine (Tau)Participants who will receive 3g of taurine supplementation in the period of 16 weeks. |
| Placebo (PL) | Placebo comparator | Other: Placebo (PL)Participants who will receive 3g of 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;
- with any disease 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 and Exercise (Tau+Ex)Participants will receive 3g of taurine to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks. Pshysical exercise 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 | Dietary supplement | Taurine and Exercise (Tau+Ex) |
| Placebo and Exercise (PL+Ex)Participants will receive 3g of placebo to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks. Pshysical exercise 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. | Other | Placebo and Exercise (PL+Ex) |
| Taurine (Tau)Participants 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) |
| Placebo (PL)Participants will receive 3g of placebo to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks. | Other | Placebo (PL) |
Primary outcome
Metabolomic Profile
Time frame: 16 weeks
Changes in metabolites and lipids of the biological sample investigated through the metabolomics approach.
15 secondary outcomes
Gene expressions in the subcutaneous white adipose tissue (scWAT). RNA (mRNA) levels of infammatory gene markers.
Time frame: 16 weeks
Gene expressions in the subcutaneous white adipose tissue (scWAT). RNA (mRNA) levels of oxidative stress genes markers.
Time frame: 16 weeks
Gene expressions in the subcutaneous white adipose tissue (scWAT). RNA (mRNA) levels of lipid oxidation genes markers.
Time frame: 16 weeks
Functional ability tests: Six-minute walk test (minutes)
Time frame: 16 weeks
Functional ability tests: forearm flexion test (seconds)
Time frame: 16 weeks
Functional ability tests: muscle strength (dynamometer) - highest peak force (KGF)
Time frame: 16 weeks
Functional ability tests: chair sit-up test. (seconds)
Time frame: 16 weeks
Indirect calorimetry assessment
Time frame: 16 weeks
Body composition changes (%)
Time frame: 16 weeks
Anthropometric measurements (Body weight)
Time frame: 16 weeks
Anthropometric - height assessment (meters)
Time frame: 16 weeks
Anthropometric measurements (Circumferences)
Time frame: 16 weeks
Others changes in metabolic parameters
Time frame: 16 weeks
Food Intake changes
Time frame: 16 weeks
Changes in Plasma Taurine Concentration
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 Jun 2022.
- Individual participant dataSharing planned: No
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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, Ph.D. principal investigator
University of São Paulo, School of Physical Education and Sports of Ribeirão Preto
Questions about this trial
What is this clinical trial studying?
A study testing Taurine and Exercise (Tau+Ex) and Taurine (Tau) in people with Sarcopenic Obesity, run by University of Sao Paulo.
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 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Gabriela F Abud, M.Sc. (+5516997940181, gabriela.abud@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolomic Profile (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 Jun 2022.