Plasma Taurine in Older Women With Obesity: Impact of Metabolic Phenotype and Combined Exercise (non applicable)
2026年7月16日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
36
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Ellen Cristini de Freitas, Dr
- 電話番号：+551633150345
- メール：ellenfreitas@usp.br
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：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
|
|
他の：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Plasma taurine concentrations (µmol/L).
時間枠：16 weeks
|
It will be analyzed by high-performance liquid chromatography.
|
16 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Systolic and diastolic blood pressure (mmHg)
時間枠：16 weeks
|
Using sphygmomanometer
|
16 weeks
|
|
Waist and hip circumferences (cm)
時間枠：16 weeks
|
non-stretch anthropometric tape
|
16 weeks
|
|
Appendicular lean soft tissue (kg).
時間枠：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 (%)
時間枠：16 weeks
|
Dual-energy X-ray Absorptiometry
|
16 weeks
|
|
Visceral fat (kg)
時間枠：16 weeks
|
Dual-energy X-ray Absorptiometry
|
16 weeks
|
|
Body mass (kg)
時間枠：16 weeks
|
Dual-energy X-ray Absorptiometry
|
16 weeks
|
|
Body mass index, BMI (kg/m²).
時間枠：16 weeks
|
Using body mass and height measurements
|
16 weeks
|
|
Inflammatory and antiinflamatory profile
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：16 weeks
|
Application of Food Frequency Questionnaire, QFA-NOVA for each food group (g/group).
|
16 weeks
|
|
Strength test - leg press
時間枠：16 weeks
|
Strength test - leg press - maximum repetitions pre and post intervention
|
16 weeks
|
|
Strength test - bench press
時間枠：16 weeks
|
Strength test using bench press, pre and post intervention
|
16 weeks
|
|
Funtional capacity: chair sit-to-stand
時間枠：16 weeks
|
Funtional capacity evaluation pre and post intervention
|
16 weeks
|
|
handgrip strength
時間枠：16 weeks
|
handgrip strength using manual dinamometer
|
16 weeks
|
|
funtional capacity: elbow flexion and extension
時間枠：16 weeks
|
funtional capacity: elbow flexion and extension using a dumpbell
|
16 weeks
|
|
Funtional capacity: 6-minute walk test
時間枠：16 weeks
|
6-minute walk test using an 30-meter course with markings every 3 meters.
|
16 weeks
|
|
Glycemic profile
時間枠：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
時間枠：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).
時間枠：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).
時間枠：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
時間枠：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)
時間枠：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.
時間枠：16 weeks
|
Using RT-qPCR pre and post intervention
|
16 weeks
|
|
Micronutrients (mg/dL)
時間枠：16 weeks
|
Blood Zinc, selenium, and magnesium (mg/dL) using spectrophotometry pre and post intervention
|
16 weeks
|
|
Antioxidant enzymes - Superoxide dismutase
時間枠：16 weeks
|
Superoxide Dismutase (SOD) Assay Kit Pre and post intervention (U/mg)
|
16 weeks
|
|
Antioxidants enzymes - Catalase (CAT)
時間枠：16 weeks
|
Catalase Assay Kit Pre and post intervention (U/mg)
|
16 weeks
|
|
Antioxidants enzymes: Glutationa-peroxidase GPx (U/mg)
時間枠：16 weeks
|
Glutathione Peroxidase Assay Kit Pre and post intervention
|
16 weeks
|
|
Oxidative stress markers - Malondialdehyde (nmol/mL).
時間枠：16 weeks
|
TBARS (Thiobarbituric Acid Reactive Substances) assay pre and post intervention
|
16 weeks
|
|
Relative telomere length
時間枠：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
時間枠：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
|
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月1日
一次修了 (推定)
2027年12月1日
研究の完了 (推定)
2030年3月1日
試験登録日
最初に提出
2026年7月13日
QC基準を満たした最初の提出物
2026年7月13日
最初の投稿 (実際)
2026年7月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月20日
QC基準を満たした最後の更新が送信されました
2026年7月16日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- Taurine_Obesity_Phenotypes
- 2025/17801-3 (その他の識別子：São Paulo Research Foundation (FAPESP))
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