AgingNCT07479940
Obesity and Aging: Impacts of Nutritional Counseling and Physical Exercise on Telomeres and Senescence Parameters
A study testing Combined Training and Nutritional Counseling in people with Aging and Obesity, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women onlyHealthy volunteers can take part
- What is being tested?
- Combined Training and Nutritional Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2026to 20 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- a history of cancer, autoimmune or neurodegenerative diseases;
- excessive alcohol consumption;
- smoking
- score ≤13 on the Mini-Mental State Examination (MMSE).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade de São Paulo - Escola de Educação Fisica e Esporte
Ribeirão Preto, São Paulo, 14040-907
About this study
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.
Read the 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.
- Conditions
- Aging, Obesity, Nutrition, Exercise, Telomere Shortening, Inflammation
- Being tested
- Combined Training, Nutritional Counseling
- Keywords
- aging, obesity, nutrition, nutrition counseling, exercise, combined exercise, telomere, senescence
- Medical subject headings
- Obesity, Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined TrainingOther
20 weeks of 60-minute combined training sessions (30 minutes of aerobic training and 30 minutes of strength training) three times per week
Nutritional CounselingOther
9 weeks of nutritional counseling with the purpose of teaching about essential macronutrients and their functions, encouraging adequate protein and fresh food consumption
| Study group | Role | What they receive |
|---|---|---|
| Eutrophic Group (ECG) | Active comparator | 20 eutrophic women will receive only the 9 week nutritional counseling Receives: Other: Nutritional Counseling |
| Eutrophic Exercise Group (EEG) | Experimental | 20 eutrophic women will receive 20 weeks of combined training after the 9 week nutritional counseling Receives: Other: Combined Training; Other: Nutritional Counseling |
| Obesity Group (OCG) | Active comparator | 20 obese women will receive only the 9 week nutritional counseling Receives: Other: Nutritional Counseling |
| Obesity Exercise Group (OEG) | Experimental | 20 obese women will receive 20 weeks of combined training after the 9 week nutritional counseling Receives: Other: Combined Training; Other: Nutritional Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 0, 9 and 29 weeks
Secondary outcomes (13)
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.
Measured: 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.
Measured: 9 and 29 weeks
Redox state analysis;
Assessment of redox status, DNA damage, and activity of enzymes associated with the redox system
Measured: 9 and 29 weeks
Analysis of mitochondrial function
Analysis of the expression of genes associated with mitochondrial functionality and biogenesis
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 9 and 29 weeks
Handgrip strength measured using a hand dynamometer
To evaluate maximal isometric handgrip strength using a calibrated hand dynamometer
Measured: 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.
Measured: 9 and 29 weeks
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.
Measured: 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.
Measured: 9 and 29 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Mar 2026
- Primary completion20 Oct 2026 (estimated)
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen Cristini de Freitas, University of Sao Paulo
- Investigators
- Ellen C de Freitas, PhD, Study director, Professor and researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479940
- Sponsor's protocol ID
- Elderly_nutrition_exercise
- Status last verified
- Mar 2026
- First submitted
- 17 Jun 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There will be no sharing of individual participant dara, only general data after publications in periodics or presentation in congresses
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity and Aging: Impacts of Nutritional Counseling and Physical Exercise on Telomeres and Senescence Parameters
- ClinicalTrials.gov ID
- NCT07479940
- Acronym / sponsor ID
- Elderly_nutrition_exercise
- Conditions
- Aging, Obesity, Nutrition, Exercise, Telomere Shortening, Inflammation
- Keywords
- aging, obesity, nutrition, nutrition counseling, exercise, combined exercise, telomere, senescence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 20 Oct 2026 (estimated)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Eutrophic Group (ECG) | Active comparator | Other: Nutritional Counseling20 eutrophic women will receive only the 9 week nutritional counseling |
| Eutrophic Exercise Group (EEG) | Experimental | Other: Combined Training, Other: Nutritional Counseling20 eutrophic women will receive 20 weeks of combined training after the 9 week nutritional counseling |
| Obesity Group (OCG) | Active comparator | Other: Nutritional Counseling20 obese women will receive only the 9 week nutritional counseling |
| Obesity Exercise Group (OEG) | Experimental | Other: Combined Training, Other: Nutritional Counseling20 obese women will receive 20 weeks of combined training after the 9 week nutritional counseling |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- a history of cancer, autoimmune or neurodegenerative diseases;
- excessive alcohol consumption;
- smoking
- score ≤13 on the Mini-Mental State Examination (MMSE).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Training20 weeks of 60-minute combined training sessions (30 minutes of aerobic training and 30 minutes of strength training) three times per week | Other | Eutrophic Exercise Group (EEG), Obesity Exercise Group (OEG) |
| Nutritional Counseling9 weeks of nutritional counseling with the purpose of teaching about essential macronutrients and their functions, encouraging adequate protein and fresh food consumption | Other | Eutrophic Exercise Group (EEG), Eutrophic Group (ECG), Obesity Exercise Group (OEG), Obesity Group (OCG) |
Primary outcome
Telomere length in peripheral blood mononuclear cells (PBMCs) measured by quantitative PCR
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
13 secondary outcomes
Expression of telomere-related genes measured by RT-qPCR
Time frame: 9 and 29 weeks
Expression of cellular senescence-associated genes in peripheral blood mononuclear cells measured by RT-qPCR
Time frame: 9 and 29 weeks
Redox state analysis;
Time frame: 9 and 29 weeks
Analysis of mitochondrial function
Time frame: 9 and 29 weeks
Determination of nitrogen balance
Time frame: 9 and 29 weeks
Cardiorespiratory capacity assessed by incremental cycling test with blood lactate measurement
Time frame: 9 and 29 weeks
Lower limb muscle strength assessed by isokinetic dynamometry
Time frame: 9 and 29 weeks
Upper body functional strength assessed by the arm curl test
Time frame: 9 and 29 weeks
Functional mobility assessed by the Timed Up and Go test
Time frame: 9 and 29 weeks
Handgrip strength measured using a hand dynamometer
Time frame: 9 and 29 weeks
Body composition assessed by dual-energy X-ray absorptiometry (DXA)
Time frame: 9 and 29 weeks
Body mass index calculated from measured weight and height
Time frame: 9 and 29 weeks
Waist-to-hip ratio calculated from anthropometric measurements
Time frame: 9 and 29 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No. There will be no sharing of individual participant dara, only general data after publications in periodics or presentation in congresses
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen C de Freitas, PhD study director
Professor and researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Training and Nutritional Counseling in people with Aging and Obesity, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telomere length in peripheral blood mononuclear cells (PBMCs) measured by quantitative PCR (time frame: 9 and 29 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.