Dietary Intervention and Gastrointestinal Function in Patients With Parkinson's Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Florida
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Gastroduodenal Permeability
Study Overview
Brief Summary
In this prospective, intervention study, participants with diagnosed Parkinson's disease will be instructed to follow a Mediterranean diet for five weeks. Gut permeability will be assessed using food-grade sugar molecules. Participants will provide urine and stool samples to assess gut permeability and microbial communities.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Physician-diagnosed Parkinson's disease aged 21-85 years
- •Hoehn & Yahr stage <3
- •Currently living in the same household with a healthy spouse/partner who meets study eligibility criteria and is willing to participate
- •Willing and able to complete informed consent in English
- •Willing to complete daily and weekly questionnaires and 6 dietary recalls over approximately 7 weeks
- •Willing to avoid beer, wine, and cocktails on the day before and the day of the sugar probe tests.
- •Willing to provide urine and stool samples during the study collection periods.
- •Willing and able to fast (no food or drink, except water or tea) for a prolonged period of time during study urine collections.
- •Willing to maintain usual diet through the pre-baseline period
- •Willing to make dietary changes to follow a Mediterranean dietary pattern during the intervention period.
- •Willing to discontinue taking prebiotic, fiber, probiotic, herbal, or high-dose vitamin or mineral supplements that may impact inflammation during the pre-baseline period and throughout the study protocol.
- •Willing to limit use of oral laxative medication to an "as-needed basis" (i.e. <3 times per week) during the full length of the study
- •Willing to avoid high intensity exercises two days prior to and the day of the permeability tests. These tests will be done on two occasions.
- •Willing to provide a social security number to receive study payment.
Exclusion Criteria
- •Does not meet above criteria
- •Atypical or secondary Parkinsonism
- •History of deep brain stimulation
- •Daily use of NSAIDs in the last 3 months or incidental use in the last 2 weeks prior to screening.
- •Daily use of anticholinergics or prokinetic agents
- •Use of enemas or suppositories to alleviate constipation
- •Use of another investigational product within 3 months of the screening visit.
- •Antibiotic use within 2 months from the day of stool collection
- •Good adherence to the Mediterranean diet during the pre-baseline period (score >6) based on the 14-item Mediterranean Diet Assessment Tool
- •Physician-diagnosed gastrointestinal disease or condition (such as ulcerative colitis, Crohn's disease, gastroparesis, cancer, peptic ulcer disease, Celiac disease, short bowel disease, ileostomy, colostomy) other than gastroesophageal reflux or diverticular disease
Arms & Interventions
Mediterranean Diet
Participants will be given individualized diet education on the Mediterranean diet and instructed to follow the diet for the 5-week intervention period. Individualized diet education will be administered by a licensed, registered dietitian nutritionist (RDN) followed by weekly phone calls to ensure compliance, improve adherence to the diet and monitor for adverse events.
Intervention: Mediterranean Diet (Other)
Outcomes
Primary Outcomes
Gastroduodenal Permeability
Time Frame: Week 1; Week 5
The primary outcome is the change in gastroduodenal permeability induced by the Mediterranean diet. Gastroduodenal permeability will be assessed by measuring sucrose concentration in the 0 to 5-hour urine collection (end of intervention minus baseline)
Secondary Outcomes
- Stool Frequency(Week 1; Week 5)
- Gastrointestinal Symptoms(Week 1; Week 5)
- Whole Gut Permeability(Week 1; Week 5)
- Colonic Permeability(Week 1; Week 5)
- Stool Consistency(Week 1; Week 5)
- Small Intestinal Permeability(Week 1; Week 5)