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Plasma Taurine in Older Women With Obesity: Impact of Metabolic Phenotype and Combined Exercise (non applicable)

16 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

36

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Ellen Cristini de Freitas, Dr
  • Telefoonnummer: +551633150345
  • E-mail: ellenfreitas@usp.br

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: 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.
Gedragsmatig: Physical Training of 16 weeks
Combined physical Training during 16 weeks
Ander: 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.
Gedragsmatig: Physical Training of 16 weeks
Combined physical Training during 16 weeks

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Plasma taurine concentrations (µmol/L).
Tijdsspanne: 16 weeks
It will be analyzed by high-performance liquid chromatography.
16 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Systolic and diastolic blood pressure (mmHg)
Tijdsspanne: 16 weeks
Using sphygmomanometer
16 weeks
Waist and hip circumferences (cm)
Tijdsspanne: 16 weeks
non-stretch anthropometric tape
16 weeks
Appendicular lean soft tissue (kg).
Tijdsspanne: 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 (%)
Tijdsspanne: 16 weeks
Dual-energy X-ray Absorptiometry
16 weeks
Visceral fat (kg)
Tijdsspanne: 16 weeks
Dual-energy X-ray Absorptiometry
16 weeks
Body mass (kg)
Tijdsspanne: 16 weeks
Dual-energy X-ray Absorptiometry
16 weeks
Body mass index, BMI (kg/m²).
Tijdsspanne: 16 weeks
Using body mass and height measurements
16 weeks
Inflammatory and antiinflamatory profile
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 16 weeks
Application of Food Frequency Questionnaire, QFA-NOVA for each food group (g/group).
16 weeks
Strength test - leg press
Tijdsspanne: 16 weeks
Strength test - leg press - maximum repetitions pre and post intervention
16 weeks
Strength test - bench press
Tijdsspanne: 16 weeks
Strength test using bench press, pre and post intervention
16 weeks
Funtional capacity: chair sit-to-stand
Tijdsspanne: 16 weeks
Funtional capacity evaluation pre and post intervention
16 weeks
handgrip strength
Tijdsspanne: 16 weeks
handgrip strength using manual dinamometer
16 weeks
funtional capacity: elbow flexion and extension
Tijdsspanne: 16 weeks
funtional capacity: elbow flexion and extension using a dumpbell
16 weeks
Funtional capacity: 6-minute walk test
Tijdsspanne: 16 weeks
6-minute walk test using an 30-meter course with markings every 3 meters.
16 weeks
Glycemic profile
Tijdsspanne: 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
Tijdsspanne: 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).
Tijdsspanne: 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).
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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.
Tijdsspanne: 16 weeks
Using RT-qPCR pre and post intervention
16 weeks
Micronutrients (mg/dL)
Tijdsspanne: 16 weeks
Blood Zinc, selenium, and magnesium (mg/dL) using spectrophotometry pre and post intervention
16 weeks
Antioxidant enzymes - Superoxide dismutase
Tijdsspanne: 16 weeks
Superoxide Dismutase (SOD) Assay Kit Pre and post intervention (U/mg)
16 weeks
Antioxidants enzymes - Catalase (CAT)
Tijdsspanne: 16 weeks
Catalase Assay Kit Pre and post intervention (U/mg)
16 weeks
Antioxidants enzymes: Glutationa-peroxidase GPx (U/mg)
Tijdsspanne: 16 weeks
Glutathione Peroxidase Assay Kit Pre and post intervention
16 weeks
Oxidative stress markers - Malondialdehyde (nmol/mL).
Tijdsspanne: 16 weeks
TBARS (Thiobarbituric Acid Reactive Substances) assay pre and post intervention
16 weeks
Relative telomere length
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Sao Paulo

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 december 2027

Studie voltooiing (Geschat)

1 maart 2030

Studieregistratiedata

Eerst ingediend

13 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

13 juli 2026

Eerst geplaatst (Werkelijk)

17 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

16 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Taurine_Obesity_Phenotypes
  • 2025/17801-3 (Andere identificatie: São Paulo Research Foundation (FAPESP))

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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