- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07711899
Plasma Taurine in Older Women With Obesity: Impact of Metabolic Phenotype and Combined Exercise (non applicable)
Plasma Taurine Concentrations in Older Women With Obesity: The Influence of Metabolic Phenotype and Combined Exercise Training
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Ellen Cristini de Freitas, Dr
- Número de telefone: +551633150345
- E-mail: ellenfreitas@usp.br
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria
- Women aged 60 to 75 years.
- Residents of the city or region of Ribeirão Preto, São Paulo, Brazil.
- Physically inactive for at least 3 months.
- Body mass index (BMI) ≥ 30 kg/m² (PAHO, 2002).
- Body fat percentage ≥ 35%, according to obesity diagnostic criteria (Batsis et al., 2016; Rubino et al., 2025).
Classified into one of two obesity phenotypes based on Zembic et al. (2021):
Metabolically Healthy Obesity (MHO/OMS): all of the following criteria must be met:
- Systolic blood pressure (SBP) < 130 mmHg;
- Waist-to-hip ratio < 0.95;
- Fasting blood glucose < 126 mg/dL.
Metabolically Unhealthy Obesity (MUO/OMNS): meets two or fewer of the above criteria.
Exclusion Criteria
Clinical conditions
- Contraindication to physical exercise.
Current or previous diagnosis of:
- Neoplasms;
- Autoimmune diseases;
- Hepatic diseases;
- Coronary diseases;
- Renal diseases;
- Neurodegenerative diseases;
- Infectious diseases.
Previous or ongoing treatments
- Use of medication for thyroid disorders.
- Participation in exercise training programs, nutritional counseling, or weight loss treatment within the 3 months preceding the intervention.
Lifestyle habits
- Current smoking.
- Alcohol consumption.
For MHO Group:
Medication use
- Hypoglycemic agents
- Insulin (Bell, Kivimäki, & Hamer, 2014).
- Protocol adherence *Attendance at less than 80% of the training sessions (De Carvalho et al., 2021).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: Metabolically Healthy Obesity (MHO)
Women with metabolically healthy obesity who participate in regular exercise.
Participants will undergo the study assessments for comparison with the other obesity phenotype.
|
Combined physical Training during 16 weeks
|
|
Outro: Metabolically Unhealthy Obesity (MUO)
Women with metabolically unhealthy obesity who participate in regular exercise.
Participants will undergo the study assessments for comparison with the other obesity phenotype.
|
Combined physical Training during 16 weeks
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Plasma taurine concentrations (µmol/L).
Prazo: 16 weeks
|
It will be analyzed by high-performance liquid chromatography.
|
16 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Systolic and diastolic blood pressure (mmHg)
Prazo: 16 weeks
|
Using sphygmomanometer
|
16 weeks
|
|
Waist and hip circumferences (cm)
Prazo: 16 weeks
|
non-stretch anthropometric tape
|
16 weeks
|
|
Appendicular lean soft tissue (kg).
Prazo: 16 Weeks
|
Using Dual-energy X-ray Absorptiometry (DXA), often referred to as iDXA, is a low-dose X-ray technology that measures bone mineral density (BMD) and body composition
|
16 Weeks
|
|
Total and regional body fat percentage (%)
Prazo: 16 weeks
|
Dual-energy X-ray Absorptiometry
|
16 weeks
|
|
Visceral fat (kg)
Prazo: 16 weeks
|
Dual-energy X-ray Absorptiometry
|
16 weeks
|
|
Body mass (kg)
Prazo: 16 weeks
|
Dual-energy X-ray Absorptiometry
|
16 weeks
|
|
Body mass index, BMI (kg/m²).
Prazo: 16 weeks
|
Using body mass and height measurements
|
16 weeks
|
|
Inflammatory and antiinflamatory profile
Prazo: 16 weeks
|
Changes in serum levels of cytokines will be evaluated with MILLIPLEX® Kit.
Pro- inflammatory citokines: IL-1β, MCP-1,TNF-α, IL-6, IL-13 (pg/mL), leptina e PCR-us (mg/dL), IL-10 (pg/mL) e adiponectina (mg/dL).
|
16 weeks
|
|
Food Intake
Prazo: 16 weeks
|
A food record of three non-consecutive days: two days of the week and one day in the weekend. This evaluation will last 16 weeks. Will be evaluated with Dietwin® software (São Paulo, Brazil): The macronutrients, micronutrients and fiber in quilocalories and percentage (%) |
16 weeks
|
|
Aerobic performance - VO2
Prazo: 16 weeks
|
Physical tests performed pre and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer.
The test aim to evaluate VO2peak in ml.kg-1.min-1.
|
16 weeks
|
|
Aerobic performance - LacAnTh
Prazo: 16 weeks
|
Physical tests performed pre and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer. The test aim to evaluate: Anaerobic threshold (AT) using lactate concentration [lac-]. |
16 weeks
|
|
Aerobic performance - IAnTh
Prazo: 16 weeks
|
Physical tests performed pre and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer. The test aim to evaluate: Anaerobic threshold (AT) using intensity in Watts (W). |
16 weeks
|
|
Aerobic performance - HRAnTh
Prazo: 16 weeks
|
Physical tests performed pre and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer. The test aim to evaluate: Anaerobic threshold (AT) using heart rate (HR). |
16 weeks
|
|
Food intake - frequency
Prazo: 16 weeks
|
Application of Food Frequency Questionnaire, QFA-NOVA for each food group (g/group).
|
16 weeks
|
|
Strength test - leg press
Prazo: 16 weeks
|
Strength test - leg press - maximum repetitions pre and post intervention
|
16 weeks
|
|
Strength test - bench press
Prazo: 16 weeks
|
Strength test using bench press, pre and post intervention
|
16 weeks
|
|
Funtional capacity: chair sit-to-stand
Prazo: 16 weeks
|
Funtional capacity evaluation pre and post intervention
|
16 weeks
|
|
handgrip strength
Prazo: 16 weeks
|
handgrip strength using manual dinamometer
|
16 weeks
|
|
funtional capacity: elbow flexion and extension
Prazo: 16 weeks
|
funtional capacity: elbow flexion and extension using a dumpbell
|
16 weeks
|
|
Funtional capacity: 6-minute walk test
Prazo: 16 weeks
|
6-minute walk test using an 30-meter course with markings every 3 meters.
|
16 weeks
|
|
Glycemic profile
Prazo: 16 weeks
|
Quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer: Changes in blood glucose (mg/dL). |
16 weeks
|
|
Lipid profile - Total cholesterol
Prazo: 16 weeks
|
Quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer: Changes in total cholesterol (mg/dL). |
16 weeks
|
|
Lipid profile: HDL-cholesterol and LDL-cholesterol (mg/dL).
Prazo: 16 weeks
|
Quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer: Changes in HDL-cholesterol and LDL-cholesterol (mg/dL). |
16 weeks
|
|
Lipid profile: triglycerides (mg/dL).
Prazo: 16 weeks
|
Quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer: Changes in triglycerides (mg/dL). |
16 weeks
|
|
Glycemic profile - C-peptide
Prazo: 16 weeks
|
C-peptide pre and post intervention using Chemiluminescence (CLIA - Chemiluminescent Immunoassay)
|
16 weeks
|
|
Expression of inflammatory and anti-inflammatory genes in peripheral blood mononuclear cells (PBMCs)
Prazo: 16 weeks
|
Using RT-qPCR pre and post-intervention.
|
16 weeks
|
|
Expression of genes related to telomere length: TRF1, TRF2, RAP1, TPP1, POT1, TIN2, and hTERT.
Prazo: 16 weeks
|
Using RT-qPCR pre and post intervention
|
16 weeks
|
|
Micronutrients (mg/dL)
Prazo: 16 weeks
|
Blood Zinc, selenium, and magnesium (mg/dL) using spectrophotometry pre and post intervention
|
16 weeks
|
|
Antioxidant enzymes - Superoxide dismutase
Prazo: 16 weeks
|
Superoxide Dismutase (SOD) Assay Kit Pre and post intervention (U/mg)
|
16 weeks
|
|
Antioxidants enzymes - Catalase (CAT)
Prazo: 16 weeks
|
Catalase Assay Kit Pre and post intervention (U/mg)
|
16 weeks
|
|
Antioxidants enzymes: Glutationa-peroxidase GPx (U/mg)
Prazo: 16 weeks
|
Glutathione Peroxidase Assay Kit Pre and post intervention
|
16 weeks
|
|
Oxidative stress markers - Malondialdehyde (nmol/mL).
Prazo: 16 weeks
|
TBARS (Thiobarbituric Acid Reactive Substances) assay pre and post intervention
|
16 weeks
|
|
Relative telomere length
Prazo: 16 weeks
|
The assay will be based on quantifying the ratio between the amplification of telomeric sequences (T) and a single-copy gene (S), enabling the estimation of relative telomere length in the biological samples.
|
16 weeks
|
|
Nitrogen balance
Prazo: 16 weeks
|
Urinary nitrogen excretion (g) will be determined using the Labtest Diagnóstica kit (UREA CE), estimating urinary nitrogen excretion based on urea levels.
Daily protein intake will also be used, pre and post intervention
|
16 weeks
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Taurine_Obesity_Phenotypes
- 2025/17801-3 (Outro identificador: São Paulo Research Foundation (FAPESP))
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