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Dietary Intervention and Gastrointestinal Function in Patients With Parkinson's Disease | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT03851861•University of Florida

View on ClinicalTrials.gov

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.

Eligibility

Age

21 - 85 years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

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

Locations (1)

University of Florida

Gainesville, Florida, United States

Key Dates

Start Date

April 15, 2019

Primary Completion Date

November 13, 2019

Completion Date

May 3, 2021

Last Updated

May 4, 2021

Enrollment

ACTUAL participants

Conditions

Parkinson Disease

Interventions

Mediterranean Diet

OTHER

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 4, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations