Plasma Taurine in Older Women With Obesity: Impact of Metabolic Phenotype and Combined Exercise (non applicable)
16 lipca 2026 zaktualizowane przez: Ellen Cristini de Freitas, University of Sao Paulo
Plasma Taurine Concentrations in Older Women With Obesity: The Influence of Metabolic Phenotype and Combined Exercise Training
Population aging has been accompanied by a rise in obesity and other chronic diseases, increasing cardiovascular risk particularly among women, who exhibit a higher prevalence in older age groups compared to men.
Aging and obesity share pathophysiological mechanisms, such as chronic inflammation and oxidative stress.
However, distinct obesity phenotypes exist, such as metabolically healthy obesity (MHO) and metabolically unhealthy obesity (MUO).
Consequently, therapeutic interventions involving nutritional strategies and physical training are highly relevant, especially for older women.
Taurine, a sulfur-containing amino acid, plays a role in modulating oxidative stress, inflammation, osmoregulation, and mitochondrial function.
Rationale: Plasma taurine concentrations are lower in women with obesity compared to healthy individuals.
However, studies investigating these concentrations across different phenotypes-particularly in older women, a group susceptible to functional and metabolic changes-remain limited.
Understanding these variations could clarify taurine's role in the pathophysiology of obesity and aging and inform personalized therapeutic strategies.
Combined physical training stands out as an effective strategy for modulating inflammatory, oxidative, and metabolic pathways, in addition to improving psychosocial aspects.
Given that taurine levels can be influenced by these pathways, investigating the taurine response to physical training across different metabolic phenotypes may contribute to developing low-cost interventions aimed at improving the quality of life for older women with obesity.
Przegląd badań
Status
Jeszcze nie rekrutacja
Interwencja / Leczenie
Szczegółowy opis
This study aims to investigate differences in plasma taurine concentrations between older women with MHO and MUO, and to evaluate the response of taurine-as well as metabolic, inflammatory, oxidative, and cellular markers-to a 16-week combined physical training intervention.
The study will involve 36 older women with obesity, classified as having either MHO or MUO.
In Stage 1, nutritional and anthropometric assessments will be conducted, along with the collection of biological samples for biochemical and molecular analyses.
In Stage 2, participants will undergo a combined physical exercise intervention for 16 weeks; nutritional, anthropometric, physical performance, and functional assessments will be performed, as well as the collection of biological samples for pre- and post-intervention biochemical and molecular analyses.
Stage 3 will consist of integrated data analysis to identify variables predicting plasma taurine concentrations at baseline and post-intervention.
Data analysis method: Data will be analyzed using Student's t-tests or Mann-Whitney tests (Stage 1), ANOVA or Kruskal-Wallis tests (Stage 2), Pearson or Spearman correlations (Stages 1 and 2), and linear regression models (Stage 3), using SPSS software (α=5%).
Expected results: It is expected that older women with OMS will exhibit higher baseline taurine concentrations and that combined physical training will increase these concentrations in both groups-with a more pronounced effect in the OMS phenotype-in addition to promoting cardiometabolic, functional, inflammatory, oxidative, and psychosocial benefits.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
36
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Ellen Cristini de Freitas, Dr
- Numer telefonu: +551633150345
- E-mail: ellenfreitas@usp.br
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Tak
Opis
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).
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Inny: 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
|
|
Inny: 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
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Plasma taurine concentrations (µmol/L).
Ramy czasowe: 16 weeks
|
It will be analyzed by high-performance liquid chromatography.
|
16 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Systolic and diastolic blood pressure (mmHg)
Ramy czasowe: 16 weeks
|
Using sphygmomanometer
|
16 weeks
|
|
Waist and hip circumferences (cm)
Ramy czasowe: 16 weeks
|
non-stretch anthropometric tape
|
16 weeks
|
|
Appendicular lean soft tissue (kg).
Ramy czasowe: 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 (%)
Ramy czasowe: 16 weeks
|
Dual-energy X-ray Absorptiometry
|
16 weeks
|
|
Visceral fat (kg)
Ramy czasowe: 16 weeks
|
Dual-energy X-ray Absorptiometry
|
16 weeks
|
|
Body mass (kg)
Ramy czasowe: 16 weeks
|
Dual-energy X-ray Absorptiometry
|
16 weeks
|
|
Body mass index, BMI (kg/m²).
Ramy czasowe: 16 weeks
|
Using body mass and height measurements
|
16 weeks
|
|
Inflammatory and antiinflamatory profile
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 16 weeks
|
Application of Food Frequency Questionnaire, QFA-NOVA for each food group (g/group).
|
16 weeks
|
|
Strength test - leg press
Ramy czasowe: 16 weeks
|
Strength test - leg press - maximum repetitions pre and post intervention
|
16 weeks
|
|
Strength test - bench press
Ramy czasowe: 16 weeks
|
Strength test using bench press, pre and post intervention
|
16 weeks
|
|
Funtional capacity: chair sit-to-stand
Ramy czasowe: 16 weeks
|
Funtional capacity evaluation pre and post intervention
|
16 weeks
|
|
handgrip strength
Ramy czasowe: 16 weeks
|
handgrip strength using manual dinamometer
|
16 weeks
|
|
funtional capacity: elbow flexion and extension
Ramy czasowe: 16 weeks
|
funtional capacity: elbow flexion and extension using a dumpbell
|
16 weeks
|
|
Funtional capacity: 6-minute walk test
Ramy czasowe: 16 weeks
|
6-minute walk test using an 30-meter course with markings every 3 meters.
|
16 weeks
|
|
Glycemic profile
Ramy czasowe: 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
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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.
Ramy czasowe: 16 weeks
|
Using RT-qPCR pre and post intervention
|
16 weeks
|
|
Micronutrients (mg/dL)
Ramy czasowe: 16 weeks
|
Blood Zinc, selenium, and magnesium (mg/dL) using spectrophotometry pre and post intervention
|
16 weeks
|
|
Antioxidant enzymes - Superoxide dismutase
Ramy czasowe: 16 weeks
|
Superoxide Dismutase (SOD) Assay Kit Pre and post intervention (U/mg)
|
16 weeks
|
|
Antioxidants enzymes - Catalase (CAT)
Ramy czasowe: 16 weeks
|
Catalase Assay Kit Pre and post intervention (U/mg)
|
16 weeks
|
|
Antioxidants enzymes: Glutationa-peroxidase GPx (U/mg)
Ramy czasowe: 16 weeks
|
Glutathione Peroxidase Assay Kit Pre and post intervention
|
16 weeks
|
|
Oxidative stress markers - Malondialdehyde (nmol/mL).
Ramy czasowe: 16 weeks
|
TBARS (Thiobarbituric Acid Reactive Substances) assay pre and post intervention
|
16 weeks
|
|
Relative telomere length
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 października 2026
Zakończenie podstawowe (Szacowany)
1 grudnia 2027
Ukończenie studiów (Szacowany)
1 marca 2030
Daty rejestracji na studia
Pierwszy przesłany
13 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
13 lipca 2026
Pierwszy wysłany (Rzeczywisty)
17 lipca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
20 lipca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
16 lipca 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Taurine_Obesity_Phenotypes
- 2025/17801-3 (Inny identyfikator: São Paulo Research Foundation (FAPESP))
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .