Clinical trial NCT03851861: Dietary Intervention and Gastrointestinal Function in Patients With Parkinson's Disease
Official title: Dietary Intervention and Gastrointestinal Function in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Intestinal Permeability
Mediterranean Diet
Leaky Gut
Intestinal Barrier Function
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 8
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective intervention study in which participants with diagnosed Parkinson's disease are instructed to follow the Mediterranean diet for a 5-week intervention period.
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Gastroduodenal Permeability
timeFrame: Week 1; Week 5
Secondary outcomes:
measure: Small Intestinal Permeability
timeFrame: Week 1; Week 5
measure: Colonic Permeability
timeFrame: Week 1; Week 5
measure: Whole Gut Permeability
timeFrame: Week 1; Week 5
measure: Stool Frequency
timeFrame: Week 1; Week 5
measure: Stool Consistency
timeFrame: Week 1; Week 5
measure: Gastrointestinal Symptoms
timeFrame: Week 1; Week 5
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: Univeristy of Florida
name: Bobbi Langkamp-Henken, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rusch C, Beke M, Tucciarone L, Nieves C Jr, Ukhanova M, Tagliamonte MS, Mai V, Suh JH, Wang Y, Chiu S, Patel B, Ramirez-Zamora A, Langkamp-Henken B. Mediterranean Diet Adherence in People With Parkinson's Disease Reduces Constipation Symptoms and Changes Fecal Microbiota After a 5-Week Single-Arm Pilot Study. Front Neurol. 2021 Dec 23;12:794640. doi: 10.3389/fneur.2021.794640. eCollection 2021.