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Active, Not Recruiting

NCT Number: NCT06734468

Personalized Approach to Promote Healthy Aging

The goal of this clinical trial study is to evaluate the impact of a personalized lifestyle intervention on improving healthspan. The primary questions of interest are whether the personalized intervention will result in improvements in muscle function, immune function, and cognitive function in adults aged 50-85 years. Participants will complete baseline assessments, receive an individualized intervention plan for approximately 3 months, and then complete post-intervention assessments. The intervention includes an exercise plan, nutrition recommendations, and general lifestyle goals that will be personalized to each participant.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Aging Aging, Healthy

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wexford Innovation Center

Phoenix, Arizona, 85004, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 50-85 years of age
  • Non-smoking
  • Ambulatory without the need of an assistive device (walker, cane, etc.) and able to perform exercise testing and exercise training
  • English speaking
  • Owns a smart phone

Exclusion criteria

  • Minors and adults younger than age 50 years and older than 85 years
  • Pregnant women
  • Adults who are unable to provide informed consent
  • Prisoners

Treatment and study plan

Lifestyle Management

Behavioral

Each subject will receive a personalized intervention plan, comprised of:

  • An individualized exercise plan guided by a mobile phone app.
  • Healthy diet and nutrition recommendations.
  • Theriome metabolomics testing and individualized recommendations that include dietary supplements.
  • Guidance on healthy sleep patterns, stress management, and maximizing social engagement, as appropriate.

Other names: Nutrition, Sleep habits, Stress management, Social engagement, Exercise

Primary outcomes

  1. VO2 max

    Time frame: From baseline to the end of the intervention at 3 months.

    A maximal treadmill exercise test with respiratory gas exchange analysis to assess cardiorespiratory fitness.

  2. Biodex

    Time frame: From baseline to the end of the intervention at 3 months.

    A Biodex will be used to assess leg muscle power and strength.

Secondary outcomes

  1. World Health Organization Quality of Life Survey

    Time frame: From baseline to the end of the intervention at 3 months.

    We will assess quality of life with the WHO_QoL. The WHO_QoL is scored from 0-100 with a higher score indicating a higher quality of life.

  2. Pittsburgh Sleep Quality Index

    Time frame: From baseline to the end of the intervention at 3 months.

    This questionnaire assesses sleep quality. The PSQI is scored on a scale from 0-21 with a higher score indicating higher sleep quality.

  3. Handgrip strength

    Time frame: From baseline to the end of the intervention at 3 months.

    A hand-held dynamometer will be used to measure handgrip strength.

  4. Dual Energy X-ray Absorptiometry (DXA)

    Time frame: From baseline to the end of the intervention at 3 months.

    A DXA scan will be used to assess body composition and bone mineral density.

  5. Waist circumference

    Time frame: From baseline to the end of the intervention at 3 months.

    Waist circumference will be measured at the superior border of the iliac crest.

  6. Hip circumference

    Time frame: From baseline to the end of the intervention at 3 months.

    Hip circumference will be measured at the maximal protrusion of the buttocks.

  7. Systolic blood pressure

    Time frame: From baseline to the end of the intervention at 3 months.

    Systolic blood pressure will be measured at rest.

  8. Diastolic blood pressure

    Time frame: From baseline to the end of the intervention at 3 months.

    Diastolic blood pressure will be measured at rest.

  9. Digit Symbol Substitution Test (DSST)

    Time frame: From baseline to the end of the intervention at 3 months.

    The DSST assesses cognition and cognitive impairment.

  10. Montreal Cognitive Assessment (MoCA)

    Time frame: From baseline to the end of the intervention at 3 months.

    The MoCA assesses cognition and cognitive impairment. The MoCA is scored out of 30 points and a higher score indicates better cognitive function.

  11. Short Physical Performance Battery

    Time frame: From baseline to the end of the intervention at 3 months.

    A performance test to assess balance and physical function.

  12. Low Density Lipoprotein Cholesterol

    Time frame: From baseline to the end of the intervention at 3 months.

    A test assessing calculated LDL cholesterol.

  13. Hemoglobin A1C Concentration

    Time frame: From baseline to the end of the intervention at 3 months.

    This will assess a participants HbA1C.

  14. Insulin Concentration

    Time frame: From baseline to the end of the intervention at 3 months.

    This test will assess a participants fasting insulin.

  15. Geriatric Depression Scale (GDS)

    Time frame: From baseline to the end of the intervention at 3 months.

    This survey assesses feelings of depression in older adults. The GDS is scored from 0-15, with a higher score indicating more feelings of depression.

  16. Generalized Anxiety Disorder (GAD)-7

    Time frame: From baseline to the end of the intervention at 3 months.

    This survey assess feelings of anxiety. The GAD-7 is scored from 0-21, with higher scores indicating higher feelings of anxiety.

  17. Perceived Stress Scale

    Time frame: From baseline to the end of the intervention at 3 months.

    This survey assesses perceived stress. This survey is scored from 0-40 with higher scores indicating higher stress.

  18. High Density Lipoprotein Cholesterol

    Time frame: From baseline to the end of the intervention at 3 months.

    A blood test measuring HDL cholesterol.

  19. Brief Resilience Scale

    Time frame: From baseline to the end of the intervention at 3 months.

    This survey assess a participants resilience. This survey is scored from 0-30 with higher scores indicating a higher level of resilience.

  20. Non-High Density Lipoprotein Cholesterol

    Time frame: From baseline to the end of the intervention at 3 months.

    A blood test measuring non-HDL cholesterol.

  21. Very Low Density Lipoprotein Cholesterol

    Time frame: From baseline to the end of the intervention at 3 months.

    A blood test measuring VLDL cholesterol.

  22. CD3 T cells

    Time frame: From baseline to the end of the intervention at 3 months.

    This test will measure how many CD3 Mature T Cells are in the blood. This will be reported as a percentage.

  23. CD4 T cells

    Time frame: From baseline to the end of the intervention at 3 months.

    This test will measure the CD4 T cells in the blood. This will be reported as a percentage.

  24. CD8 T cells

    Time frame: From baseline to the end of the intervention at 3 months.

    This test will measure the CD8 T cells in the blood. This will be reported as a percentage.

  25. Natural Killer cells

    Time frame: From baseline to the end of the intervention at 3 months.

    This test will measure the NK cells in the blood. This will be reported as a percentage.

  26. B cells

    Time frame: From baseline to the end of the intervention at 3 months.

    This test will measure the B cells in the blood. This will be reported as a percentage.

Other outcomes

  1. Resting metabolic rate

    Time frame: From baseline to the end of the intervention at 3 months.

    A test to assess how many calories the body burns at rest. RMR will be measured in the fasted state while the participant is supine.

  2. Red Blood Cells

    Time frame: From baseline to the end of the intervention at 3 months.

    This will assess the number of red blood cells.

  3. White blood cells

    Time frame: From baseline to the end of the intervention at 3 months.

    This will assess the number of white blood cells.

  4. Platelets

    Time frame: From baseline to the end of the intervention at 3 months.

    This will assess the number of platelets in the blood.

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2024
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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