Mediterranean Diet for Parkinson's Disease

(PD-Diet Trial)

Overseen By Annie Kuan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must be taking: Dopaminergic medications

Must not be taking: Immunomodulatory agents, Probiotics, Antibiotics

Disqualifiers: Atypical parkinsonism, Dementia, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 18 months

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this pilot study is to examine the feasibility and effects of an 18-month intervention diet compared to an active control diet (standard diet) in those living with Parkinson's Disease (PD), without dementia. Research has shown that eating components of Mediterranean diets are associated with a 30% lower risk to develop PD and a 40% lower mortality rate in those living with PD. Diet may influence the gut and microbiomes, thus may affect PD risk and progression. This study will examine how easy it will be to adhere to a certain type of diet for 18 months and what changes may occur in the gut microbiome and in PD symptoms on a specific diet during that time. The study will involve in-person study visits at UBC as well as online diet coaching sessions and online group cooking classes over Zoom. This is a randomized study, meaning that participants will be assigned by chance to either the Mediterranean-style diet group or the standard diet group for the duration of the 18 months. This pilot study will also examine recruitment rates and retention, in order to prepare for a larger future study.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be on a stable dopaminergic medication for at least one month before starting the study.

What data supports the effectiveness of the Mediterranean-style diet as a treatment for Parkinson's Disease?

Research suggests that following a Mediterranean diet may help reduce the severity of Parkinson's Disease symptoms and increase antioxidant levels in the body, which can protect against cell damage. Additionally, this diet has been linked to slower cognitive decline, which is often seen in advanced stages of the disease. ^{1 2 3 4 5}

Is the Mediterranean diet safe for people with Parkinson's disease?

The Mediterranean diet is generally considered safe for humans, including those with Parkinson's disease. Studies have shown it may have health benefits, such as increasing antioxidant levels, without indicating any specific safety concerns. ^{1 2 3 4 6}

How does the Mediterranean diet treatment differ from other treatments for Parkinson's disease?

The Mediterranean diet treatment for Parkinson's disease is unique because it focuses on dietary changes rather than medication, aiming to slow cognitive decline and improve antioxidant levels in the body. This diet emphasizes whole foods like fruits, vegetables, and healthy fats, which may help reduce disease severity and influence gut health, potentially offering neuroprotective benefits. ^{1 2 3 4 7}

Research Team

Silke Appel-Cresswell, MD, FRCPC

Principal Investigator

University of British Columbia

Eligibility Criteria

This trial is for people aged 40-80 with Parkinson's Disease but no dementia. Participants must speak English, be on stable PD medication for at least a month, have internet and computer access, and can attend online sessions and travel to UBC for in-person visits.

Inclusion Criteria

You do not have dementia or significant memory problems.

I am between 40 and 80 years old.

I have been diagnosed with Parkinson's disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Run-in

Participants undergo a 4-week run-in phase to further assess eligibility

4 weeks

1 visit (in-person)

Baseline

Baseline assessments and randomization into diet groups

2 days

1 visit (in-person)

Treatment

Participants follow either a Mediterranean-style diet or a standard diet with virtual coaching and cooking classes

18 months

6 visits (in-person), multiple virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Mediterranean-style diet

Trial Overview The study tests the effects of an 18-month Mediterranean-style diet versus a standard diet on individuals with Parkinson's Disease. It will assess adherence to the diets, changes in gut microbiome, PD symptoms, recruitment rates, and retention.

Participant Groups

Group I: Intervention healthy diet Experimental Treatment 1 Intervention

Participants in the active intervention group will have specific diet advice delivered with motivational and behaviour-change techniques and will learn relevant cooking skills in remotely-delivered group cooking classes (via Zoom).

Group II: Standard diet Active Control 1 Intervention

The active control group will focus on an energy-adequate diet considered standard-of-care but similar to the participant's baseline diet. The control dietary intervention group will receive general diet advice and standard care and will receive instruction in cooking skills delivered in remote group cooking classes (via Zoom).

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Weston Family Foundation

Collaborator

Weston Family Foundation

Collaborator

Trials

4

Recruited

290+

Findings from Research

A study of 600 Italian Parkinson's Disease patients showed that their adherence to the Mediterranean diet was similar to that of matched controls, indicating that dietary habits may not significantly differ in terms of overall diet quality despite some variations in food preferences.

Patients with Parkinson's Disease consumed less alcohol, fish, and fluids, and had a preference for softer foods due to swallowing difficulties, which could impact their nutritional management and hydration status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary habits in Parkinson's disease: Adherence to Mediterranean diet. Cassani, E., Barichella, M., Ferri, V., et al.[2018]

The Mediterranean Eating Pattern for Americans (MEPA-III) screener is a valid and feasible tool for assessing adherence to a Mediterranean diet in older adults with Parkinson's disease, showing a good correlation with the established VioScreen™ Food Frequency Questionnaire.

Participants found the MEPA-III screener acceptable and easy to use, with a median completion time of just over 4 minutes, making it a practical option for monitoring dietary patterns that may influence cognitive decline in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of an Online Screener, the Mediterranean Eating Pattern for Americans-III in Older Patients with Parkinson's Disease. Weaver, KE., Goldman, JG., Ribbens, N., et al.[2020]

Adherence to a Mediterranean diet is linked to a slower increase in the probability of developing prodromal Parkinson's disease (pPD) over a follow-up period of about 3 years, suggesting a protective effect against neurodegeneration.

Participants with higher adherence to the Mediterranean diet had a 60%-70% lower risk of developing possible/probable pPD compared to those with the lowest adherence, and each unit increase in the diet score was associated with a 9%-10% lower risk of developing Parkinson's disease or dementia with Lewy bodies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediterranean diet is associated with a lower probability of prodromal Parkinson's disease and risk for Parkinson's disease/dementia with Lewy bodies: A longitudinal study. Maraki, MI., Yannakoulia, M., Xiromerisiou, G., et al.[2023]

In a study of 70 patients with Parkinson's disease, following a Mediterranean Diet significantly increased serum Total Antioxidant Capacity (TAC), suggesting potential benefits for oxidative stress management.

Patients on the Mediterranean Diet also experienced a reduction in disease severity, as indicated by lower scores on the Unified Parkinson's Disease Rating Scale (UPDRS), highlighting its efficacy in improving motor and non-motor symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of Mediterranean diet on severity of disease and serum Total Antioxidant Capacity (TAC) in patients with Parkinson's disease: a single center, randomized controlled trial. Paknahad, Z., Sheklabadi, E., Moravejolahkami, AR., et al.[2022]

There is currently no cure for Parkinson's disease (PD), which is a fatal neurodegenerative condition characterized by the loss of dopamine neurons in the brain.

Animal studies suggest that dietary factors play a crucial role in protecting against dopamine degeneration, indicating that adopting a healthy diet, like the Mediterranean diet, may help reduce the risk of developing PD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A diet for dopaminergic neurons? Di Giovanni, G.[2019]

In a study of 257 Parkinson's disease (PD) patients and 198 controls, higher adherence to a Mediterranean-type diet was linked to lower odds of having PD, suggesting a potential protective effect of this diet against the disease.

Additionally, lower adherence to the Mediterranean diet was associated with an earlier age of onset for PD, indicating that dietary habits may influence the progression of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between Mediterranean diet adherence and Parkinson's disease. Alcalay, RN., Gu, Y., Mejia-Santana, H., et al.[2021]

Adherence to the Mediterranean diet (MeDi) is linked to a lower risk of developing Alzheimer's disease (AD) and Parkinson's disease (PD), based on a systematic review of 64 studies.

Specific gut bacteria were found to have an inverse relationship with MeDi and the risk of AD and PD, suggesting that the diet may influence gut microbiota in a way that could protect against these neurodegenerative diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediterranean diet adherence, gut microbiota, and Alzheimer's or Parkinson's disease risk: A systematic review. Solch, RJ., Aigbogun, JO., Voyiadjis, AG., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Dietary habits in Parkinson's disease: Adherence to Mediterranean diet. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Validation of an Online Screener, the Mediterranean Eating Pattern for Americans-III in Older Patients with Parkinson's Disease. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Mediterranean diet is associated with a lower probability of prodromal Parkinson's disease and risk for Parkinson's disease/dementia with Lewy bodies: A longitudinal study. [2023]

4. England pubmed.ncbi.nlm.nih.gov

The effects of Mediterranean diet on severity of disease and serum Total Antioxidant Capacity (TAC) in patients with Parkinson's disease: a single center, randomized controlled trial. [2022]

5. Austria pubmed.ncbi.nlm.nih.gov

A diet for dopaminergic neurons? [2019]

6. United States pubmed.ncbi.nlm.nih.gov

The association between Mediterranean diet adherence and Parkinson's disease. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Mediterranean diet adherence, gut microbiota, and Alzheimer's or Parkinson's disease risk: A systematic review. [2022]