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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aging; Aging, Healthy
• Intervention / Treatment: Behavioral: Lifestyle Management

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Wexford Innovation Center

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Lifestyle Intervention; All participants will receive an intervention.

Behavioral: Lifestyle Management; 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: Exercise; Nutrition; Stress management; Sleep habits; Social engagement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2 max	A maximal treadmill exercise test with respiratory gas exchange analysis to assess cardiorespiratory fitness.	From baseline to the end of the intervention at 3 months.
Biodex	A Biodex will be used to assess leg muscle power and strength.	From baseline to the end of the intervention at 3 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
World Health Organization Quality of Life Survey	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.	From baseline to the end of the intervention at 3 months.
Pittsburgh Sleep Quality Index	This questionnaire assesses sleep quality. The PSQI is scored on a scale from 0-21 with a higher score indicating higher sleep quality.	From baseline to the end of the intervention at 3 months.
Handgrip strength	A hand-held dynamometer will be used to measure handgrip strength.	From baseline to the end of the intervention at 3 months.
Dual Energy X-ray Absorptiometry (DXA)	A DXA scan will be used to assess body composition and bone mineral density.	From baseline to the end of the intervention at 3 months.
Waist circumference	Waist circumference will be measured at the superior border of the iliac crest.	From baseline to the end of the intervention at 3 months.
Hip circumference	Hip circumference will be measured at the maximal protrusion of the buttocks.	From baseline to the end of the intervention at 3 months.
Systolic blood pressure	Systolic blood pressure will be measured at rest.	From baseline to the end of the intervention at 3 months.
Diastolic blood pressure	Diastolic blood pressure will be measured at rest.	From baseline to the end of the intervention at 3 months.
Digit Symbol Substitution Test (DSST)	The DSST assesses cognition and cognitive impairment.	From baseline to the end of the intervention at 3 months.
Montreal Cognitive Assessment (MoCA)	The MoCA assesses cognition and cognitive impairment. The MoCA is scored out of 30 points and a higher score indicates better cognitive function.	From baseline to the end of the intervention at 3 months.
Short Physical Performance Battery	A performance test to assess balance and physical function.	From baseline to the end of the intervention at 3 months.
Low Density Lipoprotein Cholesterol	A test assessing calculated LDL cholesterol.	From baseline to the end of the intervention at 3 months.
Hemoglobin A1C Concentration	This will assess a participants HbA1C.	From baseline to the end of the intervention at 3 months.
Insulin Concentration	This test will assess a participants fasting insulin.	From baseline to the end of the intervention at 3 months.
Geriatric Depression Scale (GDS)	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.	From baseline to the end of the intervention at 3 months.
Generalized Anxiety Disorder (GAD)-7	This survey assess feelings of anxiety. The GAD-7 is scored from 0-21, with higher scores indicating higher feelings of anxiety.	From baseline to the end of the intervention at 3 months.
Perceived Stress Scale	This survey assesses perceived stress. This survey is scored from 0-40 with higher scores indicating higher stress.	From baseline to the end of the intervention at 3 months.
High Density Lipoprotein Cholesterol	A blood test measuring HDL cholesterol.	From baseline to the end of the intervention at 3 months.
Brief Resilience Scale	This survey assess a participants resilience. This survey is scored from 0-30 with higher scores indicating a higher level of resilience.	From baseline to the end of the intervention at 3 months.
Non-High Density Lipoprotein Cholesterol	A blood test measuring non-HDL cholesterol.	From baseline to the end of the intervention at 3 months.
Very Low Density Lipoprotein Cholesterol	A blood test measuring VLDL cholesterol.	From baseline to the end of the intervention at 3 months.
CD3 T cells	This test will measure how many CD3 Mature T Cells are in the blood. This will be reported as a percentage.	From baseline to the end of the intervention at 3 months.
CD4 T cells	This test will measure the CD4 T cells in the blood. This will be reported as a percentage.	From baseline to the end of the intervention at 3 months.
CD8 T cells	This test will measure the CD8 T cells in the blood. This will be reported as a percentage.	From baseline to the end of the intervention at 3 months.
Natural Killer cells	This test will measure the NK cells in the blood. This will be reported as a percentage.	From baseline to the end of the intervention at 3 months.
B cells	This test will measure the B cells in the blood. This will be reported as a percentage.	From baseline to the end of the intervention at 3 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting metabolic rate	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.	From baseline to the end of the intervention at 3 months.
Red Blood Cells	This will assess the number of red blood cells.	From baseline to the end of the intervention at 3 months.
White blood cells	This will assess the number of white blood cells.	From baseline to the end of the intervention at 3 months.
Platelets	This will assess the number of platelets in the blood.	From baseline to the end of the intervention at 3 months.

Collaborators and Investigators

• Sponsor: Arizona State University

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 8, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): December 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Aging; Healthy aging; Healthspan
• Additional Relevant MeSH Terms: Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Population Characteristics; Health Status; Demography; Nervous System Physiological Phenomena; Exercise; Nutritional Status; Sleep
• Other Study ID Numbers: STUDY00020392

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Primary and secondary outcomes will be shared.
• IPD Sharing Time Frame: Data will be made available after all data have been collected, entered into the REDCap database, data cleaning procedures have been completed, and the primary articles have been published. Data will be available on or before 1/1/2028 and will remain available for a minimum of 3 years.
• IPD Sharing Access Criteria: The Arizona State University Research Data Repository can be accessed freely by investigators. This data repository has supporting information about the protocol and contact information for the investigative team.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No