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Healthy AgingNCT06516146

Impact 360 for Healthy Agers

A study testing Exercise, Meditation and Diet in people with Healthy Aging, run by University of British Columbia at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The Impact 360 study will evaluate the effects of a combined intervention of exercise, mindfulness, and nutrition on 8 key indicators of health and the mechanisms that drive these changes. 60 subjects aged 50 to 75 without a current diagnosis of a brain disorder will be recruited. Read more about this study

Who is it for?
Ages 50 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Aging
What is being tested?
Exercise, Meditation and Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteCanada
Study dates
24 Jan 2024to 5 Jan 2028
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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participants who are able to complete questionnaires and follow directions for interventions
  • Have access to a smartphone that can support the Fitbit app

Who cannot join

  • Any neurological disease/disorder diagnosis (Ex: Parkinson's Disease, Multiple Sclerosis, Traumatic Brain Injury, Brain lesion, Stroke, etc)
  • Any chronic medical condition which would affect ability to participate in exercise
  • Any contraindication for exercise based on the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) and medical clearance form
  • Participants who were told by a medical doctor that they need to be medically supervised for exercise
  • Montreal Cognitive Assessment (MoCA) scores <21/30
  • Significant cognitive impairment, depression, or eating disorder
Show all 31Show fewer
  • Any contraindication to MRI scanning; such as implanted metal clips or wires (see list below)
  • Participants currently doing 180 minutes or more of moderate-vigorous intensity exercise per week AND either of the following:
  • Completion of an Mindfulness-Based Stress Reduction course OR; Score >8/15 in the Mediterranean-Dietary Approaches to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND) Diet Questionnaire
  • Significant or unstable cardiovascular or respiratory disease
  • Severe/multiple head trauma(s)
  • Subjects who are pregnant or breastfeeding
  • Subjects with a history or major episodes of drug or alcohol abuse
  • Chronic/acute bacterial/viral infection
  • GI cancer
  • Inflammatory bowel disease
  • Individuals weighing > 400 lbs (limit of MRI machine)
  • Artificial heart valve
  • Brain aneurysm clip
  • Electrical stimulator for nerves or bones
  • Ear or eye implant
  • Implanted drug infusion pump
  • Coil, catheter, or filter in any blood vessel
  • Orthopedic hardware (artificial joint, plate, screws)
  • Other metallic prostheses
  • Shrapnel, bullets, or other metal fragments
  • Surgery or tattoos (including tattooed eyeliner) in the last six weeks
  • Brain surgery
  • Have a cardiac pacemaker, wires or defibrillator
  • Have had an injury where a piece of metal lodged in the eye or orbit
  • Have a ferromagnetic aneurysm clip

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jeffrey Kelly, MSc contact

6048274230

jeffrey.kelly@ubc.ca

Canada1 site, 1 recruiting
  • University of British Colombia

    Vancouver, British Columbia, V6T 1Z3

    Madeleine Powell, (604) 822-8691, madeleine.powell@ubc.ca

    Annie Kuan, (604) 827-0576, annie.kuan@ubc.ca

    Recruiting

Other trials in Canada

About this study

Official title: Impact 360 Study for Healthy Agers

The Impact 360 study will evaluate the effects of a combined intervention of exercise, mindfulness, and nutrition on 8 key indicators of health and the mechanisms that drive these changes. 60 subjects aged 50 to 75 without a current diagnosis of a brain disorder will be recruited. This study will follow a partial crossover design. All participants will receive the intervention. Participants randomized into the intervention group after their baseline screening will receive the 6-month intervention. Those randomized into the waitlist group will complete another assessment at the end of the 6-month care as usual phase before receiving the intervention.

Read the detailed description

Current research suggests that exercise, meditation, and nutrition have neuroprotective effects although there is still a lack of pharmacological therapies to prevent or slow down disease progression. The benefits of these individual interventions have been shown, but emerging evidence suggests that combined interventions are more powerful than isolated ones. The crucial next step is to study the impact of a multimodal program on brain health and to comprehensively examine underlying mechanisms.

The comprehensive assessment ("360 degree approach") will focus on 8 key areas of health: cognition, inflammation, microbiome diversity, sleep quality, neurological imaging markers, physical fitness, cardiovascular health, and social and mental well-being. This comprehensive assessment in this healthy aging cohort will serve two purposes: 1) Help us to understand the mechanisms behind the benefits of this multimodal intervention and how the interactive effects influence one's overall health and 2) to serve as a normative dataset for replication of this study in clinical populations (e.g. Parkinson's disease, Alzheimer's disease, stroke)

The objective of this study is to explore the effects of this combined intervention on overall health. The investigators aim to discover the mechanisms of action behind the benefits of this multimodal intervention. The investigators will assess the impact of the intervention on overall health using the following 8 key indicators of overall health: cognition, inflammation and biomarkers, gut microbiome diversity, sleep quality, Magnetic Resonance Imaging (MRI) neurological markers, cardiorespiratory fitness and physical health, cardiovascular disease risk factors, and emotional well-being.

Conditions
Healthy Aging
Being tested
Exercise, Meditation, Diet
Keywords
Exercise, Mindfulness, Microbiome, Well-Being
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

    The intervention will involve online (via University of British Colombia (UBC) Zoom videoconferencing) 1-hour moderate to high intensity exercise classes 3 times a week for 6 months

  • MeditationBehavioural

    The intervention will involve 15 minute guided mediation following exercise classes as well as mindfulness classes.

    Mindfulness classes will consist of 1.5 hour Mindfulness Based Stress Reduction (MBSR) classes for the first 2 months, followed by 1 month of 1 hour bi-weekly discussions and practice, then MBSR 2.0 for months 4 and 5, and 1 hour bi-weekly discussions and practice for the remaining month of the intervention.

  • DietBehavioural

    The intervention will involve biweekly 1-hour nutrition and cooking classes with a dietician.

Study groups in NCT06516146
Study groupRoleWhat they receive
Exercise, Diet, MindfulnessExperimentalThe intervention group will start the intervention immediately following their baseline assessment. They will undergo another assessment after the 6 month intervention period.
Receives: Behavioral: Exercise; Behavioral: Meditation; Behavioral: Diet
Waitlist GroupNo interventionParticipants randomized into the waitlist group will undergo a baseline assessment, and will then be encouraged to continue their daily activities as usual for 6 months. Physical activity and sleep will be monitored during this time using wearable devices. Links to questionnaires will be emailed monthly. After the 6-month waitlist period, participants will undergo a second assessment prior to starting the intervention. The multimodal intervention will be 6-months in length, using the same measures of adherence, and will be followed by a final assessment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognition - NIH Toolbox Cognitive Battery

    Cognition will be measured using the National Institutes of Health (NIH) Toolbox Cognitive battery (NIHTB-CB). Testing is done pre- and post-intervention to compare scores.

    Measured: 6 Months

  2. Cognition- Montreal Cognitive Assessment

    Cognition will be measured using the Montreal Cognitive Assessment (MoCA). Testing is done pre- and post-intervention to compare scores.

    Measured: 6 Months

  3. Cognition- Parkinson's Disease Cognitive Rating Scale

    Cognition will be measured using the Parkinson's Disease Cognitive Rating Scale (PD-CRS). Testing is done pre- and post-intervention to compare scores.

    Measured: 6 Months

  4. Inflammation and Biomarkers in Serum- High Sensitivity C-Reactive Protein

    Systemic inflammation will be assessed by measuring concentrations of high sensitivity C-reactive protein (hs-CRP). Samples will be taken pre- and post-intervention to assess changes.

    Measured: 6 Months

  5. Inflammation and Biomarkers in Serum - Interleukin-1β

    Systemic inflammation will be assessed by measuring concentrations of interleukin-1β (IL-1β). Samples will be taken pre- and post-intervention to assess changes.

    Measured: 6 Months

  6. Inflammation and Biomarkers in Serum - Interleukin-6

    Systemic inflammation will be assessed by measuring concentrations of interleukin-6 (IL-6). Samples will be taken pre- and post-intervention to assess changes.

    Measured: 6 Months

  7. Inflammation and Biomarkers in Serum - Tumour Necrosis Factor Alpha

    Systemic inflammation will be assessed by measuring concentrations of Tumour Necrosis Factor Alpha (TNFa). Samples will be taken pre- and post-intervention to assess changes.

    Measured: 6 Months

  8. Inflammation and Biomarkers in Serum - Interleukin-8

    Systemic inflammation will be assessed by measuring concentrations of interleukin-8 (IL-8). Samples will be taken pre- and post-intervention to assess changes.

    Measured: 6 Months

  9. Inflammation and Biomarkers in Serum - Interleukin-10

    Systemic inflammation will be assessed by measuring concentrations of interleukin-10 (IL-10). Samples will be taken pre- and post-intervention to assess changes.

    Measured: 6 Months

  10. Inflammation and Biomarkers in Serum - Interleukin-18

    Systemic inflammation will be assessed by measuring concentrations of interleukin-18 (IL-18). Samples will be taken pre- and post-intervention to assess changes.

    Measured: 6 Months

  11. Inflammation and Biomarkers in Serum - Calprotectin

    Systemic inflammation will be assessed by measuring concentrations of calprotectin. Samples will be taken pre- and post-intervention to assess changes.

    Measured: 6 Months

  12. Inflammation and Biomarkers in Serum - cortisol

    Systemic inflammation will be assessed by measuring concentrations of cortisol. Samples will be taken pre- and post-intervention to assess changes.

    Measured: 6 Months

  13. Microbiome Diversity

    Stool samples will be analyzed for gut microbiome composition by shallow shotgun metagenome sequencing. Samples will be taken pre- and post-intervention to assess changes.

    Measured: 6 Months

  14. Sleep Efficiency

    Sleep efficiency (total sleep time/time spent in bed) will be measured through a wearable device with an accelerometer. This device will also measure other components of sleep quality such as sleep onset latency, total sleep time and wake after sleep onset.

    Measured: 6 Months

  15. Pittsburgh Sleep Quality Index

    The Pittsburgh Sleep Quality Index will be used to collect subjective sleep quality data on a monthly basis.

    Measured: 6 Months

  16. Total Grey Matter Volume

    Total grey matter volume will be measured using an MRI. Testing is done pre- and post-intervention to compares scores.

    Measured: 6 Months

  17. Hippocampal Volume

    Hippocampal volume will be measured using an MRI. Testing is done pre- and post-intervention to compares scores.

    Measured: 6 Months

  18. White matter hyperintensities volume

    White matter hyperintensities volume will be measured using an MRI. Testing is done pre- and post-intervention to compares scores.

    Measured: 6 Months

  19. Myelin Water

    Myelin water imaging will be collected using resting state functional MRI. Testing is done pre- and post-intervention to compares scores.

    Measured: 6 Months

  20. Functional MRI

    A flanker task will be administered during the MRI to examine selective attention, inhibitory function, and executive control. Testing is done pre- and post-intervention to compares scores.

    Measured: 6 Months

  21. Maximal oxygen consumption (VO2 Max)

    Predicted maximal oxygen consumption will be measured using a six-minute walk test. Testing is done pre- and post-intervention to compares scores.

    Measured: 6 Months

  22. Heart Rate Recovery

    Heart rate recovery will be measured using a three-minute step test. Testing is done pre- and post-intervention to compares scores.

    Measured: 6 Months

  23. Berg Balance Assessment

    A Berg Balance Assessment will be used to measure participants balance. Testing is done pre- and post-intervention to compares scores.

    Measured: 6 Months

  24. Dynamic Gate Index

    The Dynamic Gait Index will be used to measure participants gait. Testing is done pre- and post-intervention to compares scores.

    Measured: 6 Months

  25. Timed Up and Go Test

    The Dynamic Gait Index will be used to measure participants gait. Testing is done pre- and post-intervention to compares scores.

    Measured: 6 Months

  26. 30 Second Sit to Stand Test

    Functional lower extremity strength with be assessed using the 30 second sit to stand test. Testing is done pre- and post-intervention to compare scores.

    Measured: 6 Months

  27. Dual-Energy X-Ray Absorptiometry (DEXA)

    Body composition, such as body fat and muscle mass, will be measured using Dual-energy X-ray Absorptiometry. Testing is done pre- and post-intervention to compare scores.

    Measured: 6-Months

  28. Physical Activity Levels

    Physical activity levels will be measured through a wearable device to help ensure adherence and effectiveness of the exercise intervention. Data will be collected throughout the study.

    Measured: 6 Months

  29. Heart Rate

    Heart rate will be measured through a wearable device to help ensure adherence and effectiveness of the exercise intervention. Data will be collected throughout the study.

    Measured: 6 Months

  30. Fried Frailty Index

    Physical frailty will be assessed using the fried frailty index. Testing is done pre- and post-intervention to compares scores.

    Measured: 6 Months

  31. Blood Pressure

    Blood pressure will be measured pre- and post-intervention to compares scores.

    Measured: 6 Months

  32. Weight

    Weight will be measured pre- and post-intervention to compares scores.

    Measured: 6 Months

  33. Framingham Risk Score

    Cardiovascular health will be assessed using the Framingham Risk Score. This score includes measurements of age, total cholesterol, smoking status, HDL level, diabetes status, systolic blood pressure and treatment status. Testing is done pre- and post-intervention to compares scores.

    Measured: 6 Months

  34. NIH Toolbox- Emotional Battery

    Social, emotional, and mental well-being will be evaluated using the NIH Toolbox-Emotional Battery. Testing is done pre- and post-intervention to compares scores.

    Measured: 6 Months

  35. World Health Organization (WHO) Quality of Life Questionnaire

    Quality of life will be evaluated using the World Health Organization (WHO) Quality of Life Questionnaire. Testing is done pre- and post-intervention to compares scores.

    Measured: 6 Months

  36. Freiburg Mindfulness Inventory

    Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.

    Measured: 6 Months

  37. Mindful Attention Awareness Scale

    Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.

    Measured: 6 Months

  38. Multidimensional Assessment of Interoceptive Awareness

    Questionnaires related to mindfulness will be administered throughout the study at monthly intervals.

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2024
  2. Study start24 Jan 2024
  3. Primary completion20 Feb 2027 (estimated)
  4. Study completion5 Jan 2028 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Adults 50-75 years of age without a diagnosis of a neurodegenerative condition, will be recruited and screened for eligibility. Sixty participants will be randomly assigned to the waitlist group or the intervention group and will be striated into cohorts blocks. Each cohort block will start the intervention at the same time and will participate in the intervention together. This will allow for social interaction, engagement with their peers, and hopefully encouraging better adherence.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06516146
Sponsor's protocol ID
H21-01750
Status last verified
Feb 2026
First submitted
3 May 2024
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise, Meditation and Diet in people with Healthy Aging, run by University of British Columbia at 1 site in Canada.

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 2 inclusion and 31 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: looking for participants now, as of the sponsor's last update on 23 Mar 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 Canada. 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?

Contact Jeffrey Kelly, MSc (6048274230, jeffrey.kelly@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognition - NIH Toolbox Cognitive Battery (time frame: 6 Months). The study lists 38 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 23 Mar 2026.

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