Mediterranean Diet Intervention to Improve Gastrointestinal Function in Parkinson's Disease a Randomized, Controlled, Clinical Trial (MEDI-PD)
Parkinson Disease
About this trial
This is an interventional basic science trial for Parkinson Disease focused on measuring Mediterranean diet, Microbiome, Constipation, Inflammation
Eligibility Criteria
Inclusion Criteria:
- Physician-diagnosed Parkinson's disease aged 40-85 years
- Drug naïve or on stable dosage of Parkinson's medications with no plans to change for the duration of the study protocol
- Hoehn & Yahr stage =<2.5 in the clinical "ON" state
- Constipation syndrome scores >=2.0 based on the GSRS
- Consume <20 grams of fiber daily based on the Block Fruit/Vegetable/Fiber screener
- Able to complete informed consent in English
- Willing to maintain habitual diet through the pre-baseline period.
- Willing to make dietary changes to follow a Mediterranean diet and/or receive standard of care for constipation during the intervention period.
- Willing to complete daily and weekly questionnaires and 12 dietary recalls over approximately 10 weeks.
- Able to provide stool samples during the study collection periods.
- Willing to avoid strenuous exercise and alcohol such as beer, wine, and cocktails 24 hours prior to each of the 3 study visits.
- Able to fast (no food or drink, except water, or decaf tea) at least 12 hours before each study visit
- Willing to discontinue taking prebiotic, herbal, or high-dose vitamin or mineral supplements that may impact inflammation during the pre-baseline period and throughout the study protocol.
Exclusion Criteria:
- Atypical or secondary Parkinsonism
- Underweight (BMI <18.5)
- History of deep brain stimulation (DBS) surgery
- Regular use of enemas or suppositories to alleviate constipation (e.g., >1 time per week)
- Use of another investigational product within 3 months of the screening visit
- Antibiotic or probiotic supplement use within 2 months from the day of stool collection
- Currently being treated for a physician-diagnosed GI disease or condition other than constipation, irritable bowel disease, gastroparesis, reflux or diverticular disease
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Standard of Care + Mediterranean Diet
Standard of Care
Participants will be given standard of care for constipation (handout) plus individualized diet education on the Mediterranean diet and instructed to follow the diet during the 8-week intervention period. Diet education will be administered by a study dietitian and followed with weekly phone calls to ensure compliance, improve adherence to the diet and monitor for adverse events.
Participants will be given standard of care for constipation (handout) to utilize during the 8-week intervention period. A study dietitian will follow up with weekly phone calls to support adherence and monitor for adverse events.