Diet, Exercise, and Meditation for Parkinson's Disease

AK
JK
Overseen ByJeffrey Kelly
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of British Columbia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a mix of exercise, meditation, and diet, known as IMPACT 360, can benefit people with Parkinson's disease. Participants will either start this program immediately or begin after a 6-month period of continuing their usual routines. The researchers aim to assess how these lifestyle changes affect health indicators related to Parkinson's. Individuals diagnosed with Parkinson's who have access to a smartphone and computer may be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important early findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this combined intervention of exercise, mindfulness, and nutrition is safe for individuals with Parkinson's disease?

Previous studies have shown parts of the IMPACT 360 treatment to be safe. Research consistently shows that exercise is safe and offers health benefits, improving fitness and lowering the risk of many diseases without causing major problems.

Mindfulness meditation, another part of the treatment, has helped with both movement and non-movement symptoms in Parkinson's patients, with few negative effects reported. Studies suggest mindfulness can reduce anxiety and improve quality of life without major safety concerns.

Lastly, dietary changes, especially those rich in fruits, vegetables, whole grains, and fish, are generally safe and beneficial. Diets like the Mediterranean diet have been linked to better outcomes for Parkinson's patients.

Overall, research suggests that the components of the IMPACT 360 treatment are well-tolerated and safe for participants.12345

Why are researchers excited about this trial?

Unlike standard treatments for Parkinson's disease, which often involve medications like Levodopa to manage symptoms, the IMPACT 360 approach combines exercise, diet, and mindfulness as a holistic intervention. Researchers are excited about this trial because it explores non-pharmacological strategies that may enhance quality of life and potentially slow disease progression. By incorporating physical activity and mindfulness practices, this method aims to address both the physical and mental aspects of Parkinson's, offering a comprehensive alternative that could reduce reliance on medication.

What evidence suggests that this trial's treatments could be effective for Parkinson's disease?

This trial will compare an intervention group with a waitlist group. Research has shown that exercise can improve movement and overall health in people with Parkinson's disease. Intense exercise may protect brain cells that produce dopamine, a chemical crucial for movement. Studies suggest that a healthy diet, such as the Mediterranean diet rich in fruits, vegetables, and fish, can lessen symptoms and slow disease progression. Mindfulness meditation can reduce stress, anxiety, and depression in individuals with Parkinson's. Participants in the intervention group will engage in exercise, diet, and mindfulness practices, which together might offer a comprehensive approach to managing the disease.12678

Who Is on the Research Team?

SA

Silke Appel-Cresswell, MD, FRCPC

Principal Investigator

University of British Colombia

Are You a Good Fit for This Trial?

This trial is for people aged 40-85 diagnosed with Parkinson's disease or REM sleep behavior disorder, who can use a smartphone and computer, fill out questionnaires, and safely participate in exercise. People with serious medical issues, cognitive problems, or already doing lots of exercise can't join.

Inclusion Criteria

Access to necessary technologies (e.g., working smartphone for Fitbit, laptop or tablet for Zoom) as required by the intervention
I am between 40 and 85 years old.
Ability to fill out questionnaires
See 3 more

Exclusion Criteria

Any chronic medical condition affecting ability to participate in exercise
Contraindication for exercise based on the Physical Activity Readiness for Everyone Questionnaire (PAR-Q+) and medical clearance form
Significant cognitive impairment, depression, or eating disorder
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Group Treatment

Participants in the intervention group receive a 6-month multimodal intervention including exercise, mindfulness, and nutrition

6 months
Monthly assessments and continuous monitoring via wearable devices

Waitlist Group Observation

Participants in the waitlist group continue daily activities as usual for 6 months with monitoring

6 months
Monthly questionnaires and continuous monitoring via wearable devices

Waitlist Group Treatment

Participants in the waitlist group receive the 6-month multimodal intervention after the initial observation period

6 months
Monthly assessments and continuous monitoring via wearable devices

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • IMPACT 360

Trial Overview

The study tests the effects of a combined program of diet changes, regular exercise, and mindfulness meditation on health in people with Parkinson's. All participants will eventually receive the intervention over six months using a partial crossover design.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Exercise, Diet, MindfulnessExperimental Treatment3 Interventions
Group II: Waitlist GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials
1,506
Recruited
2,528,000+

Citations

Nutrition and Parkinson's: Science, Strategies and What ...

The Mediterranean diet has the strongest evidence for improving Parkinson's symptoms. Randomized trials showed 10 weeks of Mediterranean diet ...

Diet for the prevention and treatment of Parkinson's disease

Indeed, several studies have found that adherence to polyphenol-rich diets is associated with a lower risk of developing PD and with better clinical outcomes in ...

The Impact of Diet on Parkinson's Disease: A Systematic Review

Adherence to healthy dietary patterns, particularly those rich in fruits, vegetables, whole grains, and fish, was consistently associated with reduced PD risk.

The Role of Diet and Dietary Patterns in Parkinson's Disease

Most of the included studies support the role of diet and dietary patterns in reducing the risk of PD or alleviating PD severity.

Parkinson's Disease and Nutrition

In a subset of people with PD, ingesting levodopa along with dietary protein can decrease the medication's absorption in the small intestine, thereby decreasing ...

Association of Diet and Physical Activity With Mortality ...

This cohort study showed that a better diet quality and a higher level of physical activity were inversely associated with mortality risk among ...

Nutrition in Parkinson's disease: what neurologists need to ...

Protein redistribution diets can improve levodopa efficacy but require careful dietetic input to avoid weight loss and ensure adequate protein ...

Dietary factors in patients with Parkinson's disease

Specialized diets, such as the ketogenic diet, have shown improvements in motor and non-motor symptoms, although long-term safety requires ...