Plasma Taurine in Older Women With Obesity: Impact of Metabolic Phenotype and Combined Exercise (non applicable)
16. července 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Intervence / Léčba
Detailní popis
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 studie
Intervenční
Zápis (Odhadovaný)
36
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Ellen Cristini de Freitas, Dr
- Telefonní číslo: +551633150345
- E-mail: ellenfreitas@usp.br
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
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).
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: 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
|
|
Jiný: 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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Plasma taurine concentrations (µmol/L).
Časové okno: 16 weeks
|
It will be analyzed by high-performance liquid chromatography.
|
16 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Systolic and diastolic blood pressure (mmHg)
Časové okno: 16 weeks
|
Using sphygmomanometer
|
16 weeks
|
|
Waist and hip circumferences (cm)
Časové okno: 16 weeks
|
non-stretch anthropometric tape
|
16 weeks
|
|
Appendicular lean soft tissue (kg).
Časové okno: 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 (%)
Časové okno: 16 weeks
|
Dual-energy X-ray Absorptiometry
|
16 weeks
|
|
Visceral fat (kg)
Časové okno: 16 weeks
|
Dual-energy X-ray Absorptiometry
|
16 weeks
|
|
Body mass (kg)
Časové okno: 16 weeks
|
Dual-energy X-ray Absorptiometry
|
16 weeks
|
|
Body mass index, BMI (kg/m²).
Časové okno: 16 weeks
|
Using body mass and height measurements
|
16 weeks
|
|
Inflammatory and antiinflamatory profile
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 16 weeks
|
Application of Food Frequency Questionnaire, QFA-NOVA for each food group (g/group).
|
16 weeks
|
|
Strength test - leg press
Časové okno: 16 weeks
|
Strength test - leg press - maximum repetitions pre and post intervention
|
16 weeks
|
|
Strength test - bench press
Časové okno: 16 weeks
|
Strength test using bench press, pre and post intervention
|
16 weeks
|
|
Funtional capacity: chair sit-to-stand
Časové okno: 16 weeks
|
Funtional capacity evaluation pre and post intervention
|
16 weeks
|
|
handgrip strength
Časové okno: 16 weeks
|
handgrip strength using manual dinamometer
|
16 weeks
|
|
funtional capacity: elbow flexion and extension
Časové okno: 16 weeks
|
funtional capacity: elbow flexion and extension using a dumpbell
|
16 weeks
|
|
Funtional capacity: 6-minute walk test
Časové okno: 16 weeks
|
6-minute walk test using an 30-meter course with markings every 3 meters.
|
16 weeks
|
|
Glycemic profile
Časové okno: 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
Časové okno: 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).
Časové okno: 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).
Časové okno: 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
Časové okno: 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)
Časové okno: 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.
Časové okno: 16 weeks
|
Using RT-qPCR pre and post intervention
|
16 weeks
|
|
Micronutrients (mg/dL)
Časové okno: 16 weeks
|
Blood Zinc, selenium, and magnesium (mg/dL) using spectrophotometry pre and post intervention
|
16 weeks
|
|
Antioxidant enzymes - Superoxide dismutase
Časové okno: 16 weeks
|
Superoxide Dismutase (SOD) Assay Kit Pre and post intervention (U/mg)
|
16 weeks
|
|
Antioxidants enzymes - Catalase (CAT)
Časové okno: 16 weeks
|
Catalase Assay Kit Pre and post intervention (U/mg)
|
16 weeks
|
|
Antioxidants enzymes: Glutationa-peroxidase GPx (U/mg)
Časové okno: 16 weeks
|
Glutathione Peroxidase Assay Kit Pre and post intervention
|
16 weeks
|
|
Oxidative stress markers - Malondialdehyde (nmol/mL).
Časové okno: 16 weeks
|
TBARS (Thiobarbituric Acid Reactive Substances) assay pre and post intervention
|
16 weeks
|
|
Relative telomere length
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. října 2026
Primární dokončení (Odhadovaný)
1. prosince 2027
Dokončení studie (Odhadovaný)
1. března 2030
Termíny zápisu do studia
První předloženo
13. července 2026
První předloženo, které splnilo kritéria kontroly kvality
13. července 2026
První zveřejněno (Aktuální)
17. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
20. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
16. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Taurine_Obesity_Phenotypes
- 2025/17801-3 (Jiný identifikátor: São Paulo Research Foundation (FAPESP))
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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