Personalized Approach to Promote Healthy Aging

NCT06734468 | Active Not Recruiting

• 1 other identifier: STUDY00020392
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aging; Aging, Healthy

Keywords

Healthy aging; Aging; Healthspan

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (26)

• World Health Organization Quality of Life Survey

  From baseline to the end of the intervention at 3 months.

• Pittsburgh Sleep Quality Index

  From baseline to the end of the intervention at 3 months.

• Handgrip strength

  From baseline to the end of the intervention at 3 months.

• Dual Energy X-ray Absorptiometry (DXA)

  From baseline to the end of the intervention at 3 months.

• Waist circumference

  From baseline to the end of the intervention at 3 months.

Other Outcomes (4)

• Resting metabolic rate

  From baseline to the end of the intervention at 3 months.

• Red Blood Cells

  From baseline to the end of the intervention at 3 months.

• White blood cells

  From baseline to the end of the intervention at 3 months.

Study Arms (1)

Lifestyle Intervention

EXPERIMENTAL

All participants will receive an intervention.

Behavioral: Lifestyle Management

Interventions

Lifestyle Management BEHAVIORAL

Each subject will receive a personalized intervention plan, comprised of: 1. An individualized exercise plan guided by a mobile phone app. 2. Healthy diet and nutrition recommendations. 3. Theriome metabolomics testing and individualized recommendations that include dietary supplements. 4. Guidance on healthy sleep patterns, stress management, and maximizing social engagement, as appropriate.

Also known as: Nutrition, Sleep habits, Stress management, Social engagement, Exercise

Lifestyle Intervention

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Wexford Innovation Center

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Interventions

Nutritional Status; Sleep; Exercise

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A pre-post design will be used, with all participants receiving the intervention.

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 16, 2024
• Study Start: October 7, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.
• 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.

Locations

US (1)