Mediterranean Diet Intervention to Improve Gastrointestinal Function in Parkinson's Disease a Randomized, Controlled, Clinical Trial (MEDI-PD)

University of Florida

Status: Completed

Conditions: Parkinson Disease

Treatments: Other: Standard of care + Mediterranean diet (intervention); Other: Standard of care (control)

Study type: Interventional

Funder types: Other

Identifiers

NCT04683900

IRB202001333

Details and patient eligibility

About

This is a 10-week randomized, controlled study to investigate the effect of a Mediterranean diet intervention on gastrointestinal function in Parkinson's disease. After a 2-week run-in period, participants will be instructed to receive standard of care for constipation or receive standard of care + follow a Mediterranean diet for 8 weeks and answer daily and weekly questionnaires. Nutritional and neurological evaluations and stool samples will be collected at 0, 4 and 8 weeks.

Enrollment: 46 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Standard of Care + Mediterranean Diet

Experimental group

Description:

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.

Treatment:

Other: Standard of care + Mediterranean diet (intervention)

Standard of Care

Active Comparator group

Description:

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.

Treatment:

Other: Standard of care (control)