Physical Training of 16 weeks
BehavioralCombined physical Training during 16 weeks
NCT Number: NCT07711899
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.
Trial opening soon.
Get Notified60 year–75 year
Female
Interventional
Not applicable
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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:
Metabolically Unhealthy Obesity (MUO/OMNS): meets two or fewer of the above criteria.
Exclusion criteria
Clinical conditions
Previous or ongoing treatments
Lifestyle habits
For MHO Group:
Combined physical Training during 16 weeks
Time frame: 16 weeks
It will be analyzed by high-performance liquid chromatography.
Time frame: 16 weeks
Using sphygmomanometer
Time frame: 16 weeks
non-stretch anthropometric tape
Time frame: 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
Time frame: 16 weeks
Dual-energy X-ray Absorptiometry
Time frame: 16 weeks
Dual-energy X-ray Absorptiometry
Time frame: 16 weeks
Dual-energy X-ray Absorptiometry
Time frame: 16 weeks
Using body mass and height measurements
Time frame: 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).
Time frame: 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 (%)
Time frame: 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.
Time frame: 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-].
Time frame: 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).
Time frame: 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).
Time frame: 16 weeks
Application of Food Frequency Questionnaire, QFA-NOVA for each food group (g/group).
Time frame: 16 weeks
Strength test - leg press - maximum repetitions pre and post intervention
Time frame: 16 weeks
Strength test using bench press, pre and post intervention
Time frame: 16 weeks
Funtional capacity evaluation pre and post intervention
Time frame: 16 weeks
handgrip strength using manual dinamometer
Time frame: 16 weeks
funtional capacity: elbow flexion and extension using a dumpbell
Time frame: 16 weeks
6-minute walk test using an 30-meter course with markings every 3 meters.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 16 weeks
C-peptide pre and post intervention using Chemiluminescence (CLIA - Chemiluminescent Immunoassay)
Time frame: 16 weeks
Using RT-qPCR pre and post-intervention.
Time frame: 16 weeks
Using RT-qPCR pre and post intervention
Time frame: 16 weeks
Blood Zinc, selenium, and magnesium (mg/dL) using spectrophotometry pre and post intervention
Time frame: 16 weeks
Superoxide Dismutase (SOD) Assay Kit Pre and post intervention (U/mg)
Time frame: 16 weeks
Catalase Assay Kit Pre and post intervention (U/mg)
Time frame: 16 weeks
Glutathione Peroxidase Assay Kit Pre and post intervention
Time frame: 16 weeks
TBARS (Thiobarbituric Acid Reactive Substances) assay pre and post intervention
Time frame: 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.
Time frame: 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
Contact information is provided by the study sponsor or research team.
University of Sao Paulo
Other
Plasma Taurine Concentrations in Older Women With Obesity: The Influence of Metabolic Phenotype and Combined Exercise Training
Acronym: non applicable
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