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

NCT07479940 | Active Not Recruiting

• 1 other identifier: Elderly_nutrition_exercise
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aging; Obesity; Nutrition; Exercise; Telomere Shortening; Inflammation; Oxidative Stress; Oxidative DNA Damage

Keywords

aging; obesity; nutrition; nutrition counseling; exercise; combined exercise; telomere; senescence

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (13)

• 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

• Determination of nitrogen balance

  9 and 29 weeks

Study Arms (4)

Eutrophic Group (ECG)

ACTIVE COMPARATOR

20 eutrophic women will receive only the 9 week nutritional counseling

Other: Nutritional Counseling

Eutrophic Exercise Group (EEG)

EXPERIMENTAL

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

Other: Combined Training; Other: Nutritional Counseling

Obesity Group (OCG)

ACTIVE COMPARATOR

20 obese women will receive only the 9 week nutritional counseling

Other: Nutritional Counseling

Obesity Exercise Group (OEG)

EXPERIMENTAL

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

Other: Combined Training; Other: Nutritional Counseling

Interventions

Combined Training OTHER

20 weeks of 60-minute combined training sessions (30 minutes of aerobic training and 30 minutes of strength training) three times per week

Eutrophic Exercise Group (EEG); Obesity Exercise Group (OEG)

Nutritional Counseling OTHER

9 weeks of nutritional counseling with the purpose of teaching about essential macronutrients and their functions, encouraging adequate protein and fresh food consumption

Eutrophic Exercise Group (EEG); Eutrophic Group (ECG); Obesity Exercise Group (OEG); Obesity Group (OCG)

Eligibility Criteria

• Age: 60 Years - 75 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Universidade de São Paulo - Escola de Educação Fisica e Esporte

Ribeirão Preto, São Paulo, 14040-907, Brazil

Location

MeSH Terms

Conditions

Obesity; Motor Activity; Inflammation

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Pathologic Processes

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Ellen C de Freitas, PhD

  Professor and researcher

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Model Details: This clinical trial employs a randomized controlled design to investigate the efficacy of nutritional counseling and combined exercise on elderly women who are eutrophic or obese. The study will include 80 participants recruited from Ribeirão Preto, SP, Brazil. Eutrophic participants will be randomly assigned to two groups: one receiving 20 weeks of combined exercise following nutritional counseling, and a control group receiving only nutritional counseling. Similarly, obese participants will be randomized into these same two groups. Thus, there will be four groups in total: two comprising obese women (one intervention and one control), and two comprising eutrophic women (one intervention and one control).

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: March 18, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): October 20, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)