Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT06516146

Conditions

Healthy Aging

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

Exercise

Meditation

Diet

Study Details

Brief 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. 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.

Conditions

Healthy Aging

Study ID

NCT06516146

Start date

Jan 24, 2024

Status verified date

Feb, 2026

Completion date

Jan 5, 2028

Anticipated

Primary completion date

Feb 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • 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

Exclusion for MRI scanning:

  • 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Exercise, Diet, Mindfulness

The intervention group will start the intervention immediately following their baseline assessment. They will undergo another assessment after the 6 month intervention period.

no intervention: Waitlist Group

Participants 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.

Interventions

Exercise

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

Meditation

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.

Diet

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

Primary outcome measure

  • Cognition - NIH Toolbox Cognitive Battery [ Time Frame: 6 Months ]
  • Cognition- Montreal Cognitive Assessment [ Time Frame: 6 Months ]
  • Cognition- Parkinson's Disease Cognitive Rating Scale [ Time Frame: 6 Months ]
  • Inflammation and Biomarkers in Serum- High Sensitivity C-Reactive Protein [ Time Frame: 6 Months ]
  • Inflammation and Biomarkers in Serum - Interleukin-1β [ Time Frame: 6 Months ]
  • Inflammation and Biomarkers in Serum - Interleukin-6 [ Time Frame: 6 Months ]
  • Inflammation and Biomarkers in Serum - Tumour Necrosis Factor Alpha [ Time Frame: 6 Months ]
  • Inflammation and Biomarkers in Serum - Interleukin-8 [ Time Frame: 6 Months ]
  • Inflammation and Biomarkers in Serum - Interleukin-10 [ Time Frame: 6 Months ]
  • Inflammation and Biomarkers in Serum - Interleukin-18 [ Time Frame: 6 Months ]
  • Inflammation and Biomarkers in Serum - Calprotectin [ Time Frame: 6 Months ]
  • Inflammation and Biomarkers in Serum - cortisol [ Time Frame: 6 Months ]
  • Microbiome Diversity [ Time Frame: 6 Months ]
  • Sleep Efficiency [ Time Frame: 6 Months ]
  • Pittsburgh Sleep Quality Index [ Time Frame: 6 Months ]
  • Total Grey Matter Volume [ Time Frame: 6 Months ]
  • Hippocampal Volume [ Time Frame: 6 Months ]
  • White matter hyperintensities volume [ Time Frame: 6 Months ]
  • Myelin Water [ Time Frame: 6 Months ]
  • Functional MRI [ Time Frame: 6 Months ]
  • Maximal oxygen consumption (VO2 Max) [ Time Frame: 6 Months ]
  • Heart Rate Recovery [ Time Frame: 6 Months ]
  • Berg Balance Assessment [ Time Frame: 6 Months ]
  • Dynamic Gate Index [ Time Frame: 6 Months ]
  • Timed Up and Go Test [ Time Frame: 6 Months ]
  • 30 Second Sit to Stand Test [ Time Frame: 6 Months ]
  • Dual-Energy X-Ray Absorptiometry (DEXA) [ Time Frame: 6-Months ]
  • Physical Activity Levels [ Time Frame: 6 Months ]
  • Heart Rate [ Time Frame: 6 Months ]
  • Fried Frailty Index [ Time Frame: 6 Months ]
  • Blood Pressure [ Time Frame: 6 Months ]
  • Weight [ Time Frame: 6 Months ]
  • Framingham Risk Score [ Time Frame: 6 Months ]
  • NIH Toolbox- Emotional Battery [ Time Frame: 6 Months ]
  • World Health Organization (WHO) Quality of Life Questionnaire [ Time Frame: 6 Months ]
  • Freiburg Mindfulness Inventory [ Time Frame: 6 Months ]
  • Mindful Attention Awareness Scale [ Time Frame: 6 Months ]
  • Multidimensional Assessment of Interoceptive Awareness [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Jeffrey Kelly, MSc

6048274230jeffrey.kelly@ubc.ca

Annie Kuan

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

Locations

University of British Colombia

Recruiting

Vancouver, British Columbia, Canada, V6T 1Z3

Contacts

Madeleine Powell

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

Annie Kuan

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

Principal Investigator:

Silke Appel-Cresswell, MD, FRCPC

More Information

Sponsor

University of British Columbia

Last update posted

Mar 23, 2026

Last verified

Feb, 2026

Keywords

  • Exercise
  • Mindfulness
  • Microbiome
  • Well-Being

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-03-23.