AgingNCT06734468
Personalized Approach to Promote Healthy Aging
A study testing Lifestyle Management in people with Aging and Aging, Healthy, run by Arizona State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Aging, Healthy
- What is being tested?
- Lifestyle Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2024to Dec 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Minors and adults younger than age 50 years and older than 85 years
- Pregnant women
- Adults who are unable to provide informed consent
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Lifestyle Management
- Keywords
- Healthy aging, Aging, Healthspan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle ManagementBehavioural
Also called Nutrition, Sleep habits, Stress management, Social engagement
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.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Intervention | Experimental | All participants will receive an intervention. Receives: Behavioral: Lifestyle Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 max
A maximal treadmill exercise test with respiratory gas exchange analysis to assess cardiorespiratory fitness.
Measured: From baseline to the end of the intervention at 3 months.
Biodex
A Biodex will be used to assess leg muscle power and strength.
Measured: From baseline to the end of the intervention at 3 months.
Secondary outcomes (26)
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.
Measured: 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.
Measured: From baseline to the end of the intervention at 3 months.
Handgrip strength
A hand-held dynamometer will be used to measure handgrip strength.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to the end of the intervention at 3 months.
Systolic blood pressure
Systolic blood pressure will be measured at rest.
Measured: From baseline to the end of the intervention at 3 months.
Diastolic blood pressure
Diastolic blood pressure will be measured at rest.
Measured: From baseline to the end of the intervention at 3 months.
Digit Symbol Substitution Test (DSST)
The DSST assesses cognition and cognitive impairment.
Measured: 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.
Measured: From baseline to the end of the intervention at 3 months.
Short Physical Performance Battery
A performance test to assess balance and physical function.
Measured: From baseline to the end of the intervention at 3 months.
Low Density Lipoprotein Cholesterol
A test assessing calculated LDL cholesterol.
Measured: From baseline to the end of the intervention at 3 months.
Hemoglobin A1C Concentration
This will assess a participants HbA1C.
Measured: From baseline to the end of the intervention at 3 months.
Insulin Concentration
This test will assess a participants fasting insulin.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to the end of the intervention at 3 months.
High Density Lipoprotein Cholesterol
A blood test measuring HDL cholesterol.
Measured: 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.
Measured: From baseline to the end of the intervention at 3 months.
Non-High Density Lipoprotein Cholesterol
A blood test measuring non-HDL cholesterol.
Measured: From baseline to the end of the intervention at 3 months.
Very Low Density Lipoprotein Cholesterol
A blood test measuring VLDL cholesterol.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to the end of the intervention at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start7 Oct 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 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 Arizona State UniversityThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A pre-post design will be used, with all participants receiving the intervention.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Racette, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734468
- Sponsor's protocol ID
- STUDY00020392
- Status last verified
- Apr 2026
- First submitted
- 8 Dec 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Primary and secondary outcomes will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Approach to Promote Healthy Aging
- ClinicalTrials.gov ID
- NCT06734468
- Acronym / sponsor ID
- STUDY00020392
- Conditions
- Aging, Aging, Healthy
- Keywords
- Healthy aging, Aging, Healthspan
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Dec 2024 (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 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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A pre-post design will be used, with all participants receiving the intervention.
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Intervention | Experimental | Behavioral: Lifestyle ManagementAll participants will receive an intervention. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Minors and adults younger than age 50 years and older than 85 years
- Pregnant women
- Adults who are unable to provide informed consent
- Prisoners
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 |
|---|---|---|
| Lifestyle ManagementAlso: Nutrition, Sleep habits, Stress management, Social engagementEach 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. | Behavioural | Lifestyle Intervention |
Primary outcome
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.
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.
26 secondary outcomes
World Health Organization Quality of Life Survey
Time frame: From baseline to the end of the intervention at 3 months.
Pittsburgh Sleep Quality Index
Time frame: From baseline to the end of the intervention at 3 months.
Handgrip strength
Time frame: From baseline to the end of the intervention at 3 months.
Dual Energy X-ray Absorptiometry (DXA)
Time frame: From baseline to the end of the intervention at 3 months.
Waist circumference
Time frame: From baseline to the end of the intervention at 3 months.
Hip circumference
Time frame: From baseline to the end of the intervention at 3 months.
Systolic blood pressure
Time frame: From baseline to the end of the intervention at 3 months.
Diastolic blood pressure
Time frame: From baseline to the end of the intervention at 3 months.
Digit Symbol Substitution Test (DSST)
Time frame: From baseline to the end of the intervention at 3 months.
Montreal Cognitive Assessment (MoCA)
Time frame: From baseline to the end of the intervention at 3 months.
Short Physical Performance Battery
Time frame: From baseline to the end of the intervention at 3 months.
Low Density Lipoprotein Cholesterol
Time frame: From baseline to the end of the intervention at 3 months.
Hemoglobin A1C Concentration
Time frame: From baseline to the end of the intervention at 3 months.
Insulin Concentration
Time frame: From baseline to the end of the intervention at 3 months.
Geriatric Depression Scale (GDS)
Time frame: From baseline to the end of the intervention at 3 months.
Generalized Anxiety Disorder (GAD)-7
Time frame: From baseline to the end of the intervention at 3 months.
Perceived Stress Scale
Time frame: From baseline to the end of the intervention at 3 months.
High Density Lipoprotein Cholesterol
Time frame: From baseline to the end of the intervention at 3 months.
Brief Resilience Scale
Time frame: From baseline to the end of the intervention at 3 months.
Non-High Density Lipoprotein Cholesterol
Time frame: From baseline to the end of the intervention at 3 months.
Very Low Density Lipoprotein Cholesterol
Time frame: From baseline to the end of the intervention at 3 months.
CD3 T cells
Time frame: From baseline to the end of the intervention at 3 months.
CD4 T cells
Time frame: From baseline to the end of the intervention at 3 months.
CD8 T cells
Time frame: From baseline to the end of the intervention at 3 months.
Natural Killer cells
Time frame: From baseline to the end of the intervention at 3 months.
B cells
Time frame: From baseline to the end of the intervention at 3 months.
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 28 Apr 2026.
- Individual participant dataSharing planned: Yes. Primary and secondary outcomes will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Management in people with Aging and Aging, Healthy, run by Arizona State University at 1 site in United States.
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 5 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 28 Apr 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 United States. 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?
VO2 max (time frame: From baseline to the end of the intervention at 3 months.). The study lists 2 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 28 Apr 2026.