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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Inflammation; Obesity; Exercise; Aging; Oxidative Stress; Nutrition; Telomere Shortening; Oxidative DNA Damage
• Intervention / Treatment: Other: Nutritional Counseling; Other: Combined Training

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14040-907
      • Universidade de São Paulo - Escola de Educação Fisica e Esporte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

• 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).

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Eutrophic Group (ECG); 20 eutrophic women will receive only the 9 week nutritional counseling	Other: Nutritional Counseling; 9 weeks of nutritional counseling with the purpose of teaching about essential macronutrients and their functions, encouraging adequate protein and fresh food consumption
Experimental: Eutrophic Exercise Group (EEG); 20 eutrophic women will receive 20 weeks of combined training after the 9 week nutritional counseling	Other: Nutritional Counseling; 9 weeks of nutritional counseling with the purpose of teaching about essential macronutrients and their functions, encouraging adequate protein and fresh food consumption; Other: Combined Training; 20 weeks of 60-minute combined training sessions (30 minutes of aerobic training and 30 minutes of strength training) three times per week
Active Comparator: Obesity Group (OCG); 20 obese women will receive only the 9 week nutritional counseling	Other: Nutritional Counseling; 9 weeks of nutritional counseling with the purpose of teaching about essential macronutrients and their functions, encouraging adequate protein and fresh food consumption
Experimental: Obesity Exercise Group (OEG); 20 obese women will receive 20 weeks of combined training after the 9 week nutritional counseling	Other: Nutritional Counseling; 9 weeks of nutritional counseling with the purpose of teaching about essential macronutrients and their functions, encouraging adequate protein and fresh food consumption; Other: Combined Training; 20 weeks of 60-minute combined training sessions (30 minutes of aerobic training and 30 minutes of strength training) three times per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Telomere length in peripheral blood mononuclear cells (PBMCs) measured by quantitative PCR	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.	9 and 29 weeks
Expression of cellular senescence-related genes in PBMCs measured by quantitative RT-PCR	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.	9 and 29 weeks
Adequacy of protein intake assessed by dietary intake analysis	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.	0, 9 and 29 weeks
Percentage of ultra-processed food consumption assessed by NOVA food classification	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.	0, 9 and 29 weeks
Diet quality assessed by proportion of ultra-processed food consumption according to the NOVA classification	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	0, 9 and 29 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index calculated from measured weight and height	To assess body mass index (BMI) in elderly women. Body weight will be measured using a calibrated digital scale and height will be measured using a stadiometer following standardized anthropometric procedures. BMI will be calculated as body weight in kilograms divided by the square of height in meters.	9 and 29 weeks
Expression of telomere-related genes measured by RT-qPCR	To evaluate the expression of genes associated with telomere regulation in peripheral blood mononuclear cells (PBMCs). Gene expression will be quantified using reverse transcription quantitative polymerase chain reaction (RT-qPCR) and normalized to a housekeeping gene.	9 and 29 weeks
Expression of cellular senescence-associated genes in peripheral blood mononuclear cells measured by RT-qPCR	To evaluate the expression of genes associated with cellular senescence in peripheral blood mononuclear cells (PBMCs) collected from elderly women participating in the study. Gene expression will be quantified using reverse transcription quantitative polymerase chain reaction (RT-qPCR) and normalized to a housekeeping gene. The analyzed genes include markers involved in cellular senescence pathways such as cell cycle regulation, inflammatory response, growth signaling, and tissue remodeling.	9 and 29 weeks
Redox state analysis;	Assessment of redox status, DNA damage, and activity of enzymes associated with the redox system	9 and 29 weeks
Analysis of mitochondrial function	Analysis of the expression of genes associated with mitochondrial functionality and biogenesis	9 and 29 weeks
Determination of nitrogen balance	Determination of nitrogen balance through estimation of protein intake through 24-hour dietary recall and nitrogen excretion obtained through 24-hour urine samples	9 and 29 weeks
Cardiorespiratory capacity assessed by incremental cycling test with blood lactate measurement	To evaluate cardiorespiratory capacity using an incremental exercise test performed on a cycle ergometer. Capillary blood samples will be collected during the test to determine blood lactate concentration and identify the lactate threshold.	9 and 29 weeks
Lower limb muscle strength assessed by isokinetic dynamometry	To evaluate lower limb muscle strength using an isokinetic dynamometer. Maximal voluntary torque of the knee extensors and flexors will be measured under standardized testing conditions.	9 and 29 weeks
Upper body functional strength assessed by the arm curl test	To evaluate upper body functional strength using the arm curl test, which measures the number of arm curls performed within 30 seconds using a standardized weight.	9 and 29 weeks
Functional mobility assessed by the Timed Up and Go test	To assess functional mobility using the Timed Up and Go (TUG) test, which measures the time required for a participant to stand up from a chair, walk three meters, turn, return to the chair, and sit down.	9 and 29 weeks
Handgrip strength measured using a hand dynamometer	To evaluate maximal isometric handgrip strength using a calibrated hand dynamometer	9 and 29 weeks
Body composition assessed by dual-energy X-ray absorptiometry (DXA)	To evaluate body composition in elderly women using dual-energy X-ray absorptiometry (DXA) with an iDXA scanner. Body composition parameters including total body fat mass and lean mass will be obtained from the DXA analysis.	9 and 29 weeks
Waist-to-hip ratio calculated from anthropometric measurements	To assess body fat distribution using the waist-to-hip ratio (WHR). Waist and hip circumferences will be measured using a non-elastic flexible measuring tape according to standardized anthropometric procedures. The waist-to-hip ratio will be calculated by dividing waist circumference by hip circumference.	9 and 29 weeks

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Study Director: Ellen C de Freitas, PhD, Professor and researcher

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): October 20, 2026

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: exercise; obesity; nutrition; aging; telomere; nutrition counseling; combined exercise; senescence
• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Inflammation; Motor Activity; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Epidemiologic Measurements; Nutrition Assessment
• Other Study ID Numbers: Elderly_nutrition_exercise

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There will be no sharing of individual participant dara, only general data after publications in periodics or presentation in congresses

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No