Plasma Taurine in Older Women With Obesity: Impact of Metabolic Phenotype and Combined Exercise (non applicable)
16 июля 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
36
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Ellen Cristini de Freitas, Dr
- Номер телефона: +551633150345
- Электронная почта: ellenfreitas@usp.br
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Да
Описание
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).
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Другой: 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
|
|
Другой: 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
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Plasma taurine concentrations (µmol/L).
Временное ограничение: 16 weeks
|
It will be analyzed by high-performance liquid chromatography.
|
16 weeks
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Systolic and diastolic blood pressure (mmHg)
Временное ограничение: 16 weeks
|
Using sphygmomanometer
|
16 weeks
|
|
Waist and hip circumferences (cm)
Временное ограничение: 16 weeks
|
non-stretch anthropometric tape
|
16 weeks
|
|
Appendicular lean soft tissue (kg).
Временное ограничение: 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 (%)
Временное ограничение: 16 weeks
|
Dual-energy X-ray Absorptiometry
|
16 weeks
|
|
Visceral fat (kg)
Временное ограничение: 16 weeks
|
Dual-energy X-ray Absorptiometry
|
16 weeks
|
|
Body mass (kg)
Временное ограничение: 16 weeks
|
Dual-energy X-ray Absorptiometry
|
16 weeks
|
|
Body mass index, BMI (kg/m²).
Временное ограничение: 16 weeks
|
Using body mass and height measurements
|
16 weeks
|
|
Inflammatory and antiinflamatory profile
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 16 weeks
|
Application of Food Frequency Questionnaire, QFA-NOVA for each food group (g/group).
|
16 weeks
|
|
Strength test - leg press
Временное ограничение: 16 weeks
|
Strength test - leg press - maximum repetitions pre and post intervention
|
16 weeks
|
|
Strength test - bench press
Временное ограничение: 16 weeks
|
Strength test using bench press, pre and post intervention
|
16 weeks
|
|
Funtional capacity: chair sit-to-stand
Временное ограничение: 16 weeks
|
Funtional capacity evaluation pre and post intervention
|
16 weeks
|
|
handgrip strength
Временное ограничение: 16 weeks
|
handgrip strength using manual dinamometer
|
16 weeks
|
|
funtional capacity: elbow flexion and extension
Временное ограничение: 16 weeks
|
funtional capacity: elbow flexion and extension using a dumpbell
|
16 weeks
|
|
Funtional capacity: 6-minute walk test
Временное ограничение: 16 weeks
|
6-minute walk test using an 30-meter course with markings every 3 meters.
|
16 weeks
|
|
Glycemic profile
Временное ограничение: 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
Временное ограничение: 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).
Временное ограничение: 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).
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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.
Временное ограничение: 16 weeks
|
Using RT-qPCR pre and post intervention
|
16 weeks
|
|
Micronutrients (mg/dL)
Временное ограничение: 16 weeks
|
Blood Zinc, selenium, and magnesium (mg/dL) using spectrophotometry pre and post intervention
|
16 weeks
|
|
Antioxidant enzymes - Superoxide dismutase
Временное ограничение: 16 weeks
|
Superoxide Dismutase (SOD) Assay Kit Pre and post intervention (U/mg)
|
16 weeks
|
|
Antioxidants enzymes - Catalase (CAT)
Временное ограничение: 16 weeks
|
Catalase Assay Kit Pre and post intervention (U/mg)
|
16 weeks
|
|
Antioxidants enzymes: Glutationa-peroxidase GPx (U/mg)
Временное ограничение: 16 weeks
|
Glutathione Peroxidase Assay Kit Pre and post intervention
|
16 weeks
|
|
Oxidative stress markers - Malondialdehyde (nmol/mL).
Временное ограничение: 16 weeks
|
TBARS (Thiobarbituric Acid Reactive Substances) assay pre and post intervention
|
16 weeks
|
|
Relative telomere length
Временное ограничение: 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
Временное ограничение: 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
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 октября 2026 г.
Первичное завершение (Оцененный)
1 декабря 2027 г.
Завершение исследования (Оцененный)
1 марта 2030 г.
Даты регистрации исследования
Первый отправленный
13 июля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
13 июля 2026 г.
Первый опубликованный (Действительный)
17 июля 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
20 июля 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
16 июля 2026 г.
Последняя проверка
1 июля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- Taurine_Obesity_Phenotypes
- 2025/17801-3 (Другой идентификатор: São Paulo Research Foundation (FAPESP))
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .