Investigating muscle and health characteristics in older adults and elite athletes

An Observational Study of Aging Biomarkers in Older Elite Athletes Compared to Non-exercising Healthy Older Adults.

This study looks at how muscle and health traits differ between healthy older adults and elite athletes aged 65-80 to see how physical activity affects aging.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 65 Years to 80 Years
• Sex: All
• Sponsor: Buck Institute for Research on Aging (Academic / other)
• Locations: 1 site (Novato, California)
• Trial ID: NCT06540287 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the differences in muscle, blood, and urine characteristics between healthy older adults and older elite athletes aged 65-80. Participants will undergo a series of assessments including physical and cognitive function tests, body composition analysis, and bio-specimen collection over three visits within a 12-week period. The study will also include optional follow-up visits at 12 and 24 months to gather additional data. The goal is to better understand the impact of physical activity on aging and health biomarkers.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 65-80, including both sedentary individuals and those who are older elite athletes.

Not a fit: Patients who are not within the age range of 65-80 or those with significant health issues that prevent participation in physical assessments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into how exercise influences aging and health, potentially leading to improved health strategies for older adults.

How similar studies have performed: While there have been studies on aging and exercise, this specific approach focusing on elite older athletes compared to sedentary older adults is relatively novel.

Eligibility criteria

1. Willing and able to provide consent to take part in the MOVE-1 Main Study.
2. Willing and able to attend study visits and comply with all procedures of study data collection visits.
3. Able to read and speak English well enough to provide informed consent and understand instructions.
4. Healthy adults between the age of 65 - 80 y.
5. BMI \>19 to \< 35 kg/m2
6. No personal plans (i.e., vacations or medical procedures) during the expected study period (Screening, Test Visit 1, 2 and Sample Collection Visit).
7. Older Elite Athletes (OEA):

   • Evidence of current physical activity at an elite level for their age, as well as a consistent history of high activity level. This is assessed by interview, review of training data and/or competition results, and by review of the VO2 max data obtained during Testing Visit 1.
8. Healthy Older Adults (HOA):

   * Sedentary, defined as self-reporting no more than 1 day per week, lasting no more than 60 minutes, of regular (structured) endurance exercise \[e.g., brisk walking, jogging, running, cycling, elliptical, or swimming activity that results in feelings of increased heart rate, rapid breathing, and/or sweating\] or resistance exercise (resulting in muscular fatigue) in the past year.
   * Persons bicycling as a mode of transportation to and from work \>1 day/week etc. are not considered sedentary.
   * Leisure walkers are included unless they meet the heart rate, breathing, and sweating criteria noted above.
   * Does not have a physically active job, no history of physically active job (i.e., postal worker, fire officer
   * No history of consistent high activity level (meeting above criteria) in the last 25 y.

3.2.2. Main Study Exclusion Criteria

1. Subject requires assistance with any activity of daily living, excluding continence.
2. Subject lives in an institutional setting (skilled nursing facility or residential care facility for the elderly).
3. Abnormal bleeding or coagulopathy (self-report): History of a bleeding disorder, wound healing disorder or clotting abnormality.
4. Female participants must be post-menopause.
5. Musculoskeletal conditions that would prevent completion of any required exercise testing.
6. Elevated blood pressure readings (screening test): Resting Systolic Blood Pressure (SBP) ≥150 mmHg or resting Diastolic Blood Pressure (DBP) ≥90 mmHg
7. Diabetes (self-report and screening tests): Treatment with any hypoglycemic agents (self-report), fasting glucose \>125 mg/dL (screening test; may reassess once), use of hypoglycemic drugs for non-diabetic reasons (self-report).
8. Pulmonary (self-report): Clinical diagnosis of any chronic pulmonary disease that limits exercise capacity.
9. Cardiovascular (self-report, screening test, and clinician judgement): Congestive heart failure, coronary artery disease, significant valvular disease, congenital heart disease, serious arrhythmia, pulmonary embolism, stroke, or symptomatic peripheral artery disease (self-report, screening test). Specific criteria used to determine whether a volunteer can undergo the screening CPET follow the American Heart Association (AHA) Criteria \[6\]. Inability to complete the CPET. Reassessment of the CPET may be allowed under some circumstances (e.g., test was not a maximal effort)
10. Abnormal blood lipid profile (screening test): Fasting triglycerides \>500 mg/dL. Low-density lipoprotein cholesterol (LDL-C) \>190 mg/dL
11. Cancer (self-report): History of cancer treatment (other than non-melanoma skin cancer, or chronic lymphocytic leukemia) and not "cancer-free "for at least 2 years. Anti-hormonal therapy (e.g., for breast or prostate cancer) within the last 6 months.
12. Chronic active or latent infection (self-report): Active or latent infections requiring chronic antibiotic or anti-viral treatment, excluding herpes simplex virus. Chronic active infection whether on chronic antimicrobials or not. Human Immunodeficiency Virus. Active hepatitis B or C undergoing antiviral therapy. Individuals successfully treated for hepatitis C and virologically negative for at least 6 months are not excluded.
13. Liver enzyme tests (alanine transaminase, aspartate transaminase) (screening test): \>2 times the laboratory upper limit of normal. Reassessment during screening may be allowed under some conditions (e.g., recent use of acetaminophen). Individuals may be referred to their PCP for evaluation; any medication change must be stable for ≥3 months prior to retesting.
14. Chronic renal insufficiency (screening test): Estimated glomerular filtration rate \<60 mL/min/1.73 m2 from serum creatinine (mg/dL) by the Chronic Kidney Disease Epidemiology Collaboration equation. Subjects must be able to produce urine. Reassessment may be allowed under some conditions (e.g., questionable hydration status or other acute renal insult)
15. Hematocrit (screening test): Hematocrit \>3 points outside of the local normal laboratory ranges for women and men. Reassessment may be allowed under certain conditions. Individuals may be referred to their PCP for evaluation; any medication change must be stable for ≥3 months prior to retesting.
16. Blood donation (self-report): Whole blood donation in the last 3 months or plans for blood donation during the entire protocol period. Platelet or plasma donation in the last week or plans for platelet or plasma donation during the entire protocol period.
17. Autoimmune disorders (self-report): Individuals receiving any active systemic treatment (including immunosuppressants and/or monoclonal antibodies) within the last 6 months.
18. Alcohol consumption (self-report): Current consumption of more than 7 drinks per week for women More than 14 drinks per week for men. History of binge drinking in the past five years (≥5 drinks for males or ≥4 drinks for females in a 2-hour period more than once per month)
19. Tobacco (self-report): Current smokers: any tobacco or e-cigarette/e-nicotine products. Former smokers: Stopped smoking \<10 years at time of screening for those with a ≥20 pack-year smoking history. Stopped smoking \<5 years at time screening for those with a \<20 pack-year smoking history.
20. Recreational drug use (self-report): Self-reported use ≥3 days/week in any form
21. Shift workers (self-report): Night shift work in the last 6 months. Planning night shift work during the study period.
22. Cognitive status (screening): Unable to give consent to participate in and safely complete the protocol, as based on the judgement of the investigators.
23. Psychiatric illness (self-report and screening test): Hospitalization for any psychiatric condition within one year (self-report).
24. Weight change (self-report): Weight change (intentional or not) over the last 2 months of \>5% of body weight. Plan to lose or gain weight during the study
25. Lidocaine or other local anesthetic allergy (self-report): Known allergy to lidocaine or other local anesthetic
26. COVID-19 infection: Individuals who tested positive for COVID-19 but were not hospitalized must be symptom free, at least 14 days (without a negative antigen test) or symptom-free at least 7 days with a negative antigen test on the day of the study visit. A PCR test can be used if antigen tests are not available.
27. Other (clinician judgement): Genetic metabolic disorders that could affect metabolomic results (e.g., phenylketonuria). Any other cardiovascular, pulmonary, orthopedic, neurologic, psychiatric, metabolic, or other conditions that, in the opinion of the local clinician, would preclude participation and successful completion of the protocol. Any other illnesses that, in the opinion of the local clinician, would negatively impact or mitigate participation in and completion of the protocol.

Where this trial is running

Novato, California

• Buck Institute for Research on Aging — Novato, California, United States (Recruiting)

Study contacts

• Principal investigator: John C Newman, MD PhD — Buck Institute
• Study coordinator: Briannaa Stubbs, DPhil

Conditions Aging; Biomarkers; Healthy older adults; Older elite athletes