Dietary Intervention and Gastrointestinal Function in Patients With Parkinson's Disease



Status:Not yet recruiting
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:21 - 85
Updated:3/28/2019
Start Date:May 1, 2019
End Date:December 31, 2019
Contact:Carley Rusch, MS, RDN, LDN
Email:nutrition-study@ufl.edu
Phone:352-340-7321

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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.


Inclusion Criteria:

- Physician-diagnosed Parkinson's disease aged 21-85 years

- Hoehn & Yahr stage <3

- Lives within the Gainesville, Lake City, Ocala areas

- 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 systemic corticosteroids, androgens (such as testosterone), or 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
We found this trial at
1
site
Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Bobbi Langkamp-Henken, PhD, RD
Phone: 352-340-7321
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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