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临床试验/NCT07479940
NCT07479940进行中(未招募)不适用

Obesity and Aging: Impacts of Nutritional Counseling and Physical Exercise on Telomeres and Senescence Parameters

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
1
主要终点
Telomere length in peripheral blood mononuclear cells (PBMCs) measured by quantitative PCR

研究概览

简要总结

The study will involve 80 elderly women, 40 eutrophic and 40 obese, divided into four groups, each with n=20. 1) Eutrophic Group (EG) undergoing only nutritional counseling (NC), 2) Eutrophic Group with NC and combined training (CT), 3) Obese Group (OG) undergoing only NC, and 4) Obese Group with NC and CT. The study will be divided into two main phases: an initial 9-week phase dedicated to NC, followed by a 20-week CT phase.

详细描述

The study will involve 80 elderly women, 40 eutrophic and 40 obese, divided into four groups, each with n=20. 1) Eutrophic Group (EG) undergoing only nutritional counseling (NC), 2) Eutrophic Group with NC and combined training (CT), 3) Obese Group (OG) undergoing only NC, and 4) Obese Group with NC and CT. The study will be divided into two main phases: an initial 9-week phase dedicated to NC, followed by a 20-week CT phase. During the intervention period, dietary recalls will be collected before and after NC, as well as midway and at the end of the CT period. Additionally, baseline assessments, midway assessments, and post-CT assessments will be conducted to evaluate functional capacity, conduct anthropometric measurements, and collect 24-hour urine and blood samples for genetic and metabolic evaluations, providing a comprehensive view of the effects of the proposed interventions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
60 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • being female;
  • between 60 and 75 years old;
  • a BMI between 22 and 40 kg/m²;
  • being sedentary (not exercising for at least 3 months).

排除标准

  • a history of cancer, autoimmune or neurodegenerative diseases;
  • excessive alcohol consumption;
  • score ≤13 on the Mini-Mental State Examination (MMSE).

研究组 & 干预措施

Eutrophic Group (ECG)

Active Comparator

20 eutrophic women will receive only the 9 week nutritional counseling

干预措施: Nutritional Counseling (Other)

Eutrophic Exercise Group (EEG)

Experimental

20 eutrophic women will receive 20 weeks of combined training after the 9 week nutritional counseling

干预措施: Combined Training (Other)

Eutrophic Exercise Group (EEG)

Experimental

20 eutrophic women will receive 20 weeks of combined training after the 9 week nutritional counseling

干预措施: Nutritional Counseling (Other)

Obesity Group (OCG)

Active Comparator

20 obese women will receive only the 9 week nutritional counseling

干预措施: Nutritional Counseling (Other)

Obesity Exercise Group (OEG)

Experimental

20 obese women will receive 20 weeks of combined training after the 9 week nutritional counseling

干预措施: Combined Training (Other)

Obesity Exercise Group (OEG)

Experimental

20 obese women will receive 20 weeks of combined training after the 9 week nutritional counseling

干预措施: Nutritional Counseling (Other)

结局指标

主要结局

Telomere length in peripheral blood mononuclear cells (PBMCs) measured by quantitative PCR

时间窗: 9 and 29 weeks

To evaluate the effect of obesity, nutritional counseling, and combined physical training on leukocyte telomere length in elderly women. Telomere length will be measured in peripheral blood mononuclear cells (PBMCs) using quantitative real-time PCR (qPCR), expressed as the telomere-to-single copy gene (T/S) ratio according to the Cawthon method.

Expression of cellular senescence-related genes in PBMCs measured by quantitative RT-PCR

时间窗: 9 and 29 weeks

To assess the effect of obesity, nutritional counseling, and combined physical training on the expression of genes related to cellular senescence in peripheral blood mononuclear cells (PBMCs). Gene expression will be quantified by reverse transcription quantitative polymerase chain reaction (RT-qPCR) and normalized to a housekeeping gene.

Adequacy of protein intake assessed by dietary intake analysis

时间窗: 0, 9 and 29 weeks

To evaluate the effect of nutritional counseling on protein intake adequacy in elderly women. Dietary intake will be assessed using 24-hour dietary recalls, and protein intake will be calculated using nutritional analysis software. Adequacy will be determined by comparing individual protein intake with recommended intake values for older adults.

Percentage of ultra-processed food consumption assessed by NOVA food classification

时间窗: 0, 9 and 29 weeks

To evaluate the effect of nutritional counseling on the consumption of ultra-processed foods in elderly women. Dietary intake will be assessed using 24-hour dietary recalls. Foods will be classified according to the NOVA food classification system, and the proportion of total energy intake derived from ultra-processed foods will be calculated.

Diet quality assessed by proportion of ultra-processed food consumption according to the NOVA classification

时间窗: 0, 9 and 29 weeks

To assess the effect of nutritional counseling on diet quality in elderly women based on the degree of food processing. Dietary intake will be evaluated using 24-hour dietary recalls, and foods will be classified according to the NOVA classification system. Diet quality will be determined by calculating the proportion of total energy intake derived from ultra-processed foods, with higher values indicating poorer diet quality

次要结局

  • Body mass index calculated from measured weight and height(9 and 29 weeks)
  • Determination of nitrogen balance(9 and 29 weeks)
  • Expression of telomere-related genes measured by RT-qPCR(9 and 29 weeks)
  • Expression of cellular senescence-associated genes in peripheral blood mononuclear cells measured by RT-qPCR(9 and 29 weeks)
  • Redox state analysis;(9 and 29 weeks)
  • Analysis of mitochondrial function(9 and 29 weeks)
  • Cardiorespiratory capacity assessed by incremental cycling test with blood lactate measurement(9 and 29 weeks)
  • Lower limb muscle strength assessed by isokinetic dynamometry(9 and 29 weeks)
  • Upper body functional strength assessed by the arm curl test(9 and 29 weeks)
  • Functional mobility assessed by the Timed Up and Go test(9 and 29 weeks)
  • Handgrip strength measured using a hand dynamometer(9 and 29 weeks)
  • Body composition assessed by dual-energy X-ray absorptiometry (DXA)(9 and 29 weeks)
  • Waist-to-hip ratio calculated from anthropometric measurements(9 and 29 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ellen Cristini de Freitas

Study Director

University of Sao Paulo

研究点 (1)

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