Status:
COMPLETED
Mediterranean Diet Intervention to Improve Gastrointestinal Function in Parkinson's Disease a Randomized, Controlled, Clinical Trial
Lead Sponsor:
University of Florida
Conditions:
Parkinson Disease
Eligibility:
All Genders
40-85 years
Phase:
NA
Brief Summary
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, partici...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2022
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04683900
Start Date
February 8 2021
End Date
June 7 2022
Last Update
July 12 2022
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32611