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

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 Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Mediterranean Diet

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Other: Mediterranean Diet; Participants will be instructed to include the following in their diet: a) abundant use of olive oil for cooking and dressing dishes; b) consumption of ≥2 daily servings of vegetables; c) ≥2-3 daily serving of fresh fruits (including natural juices); d) ≥3 weekly servings of legumes; e) ≥3 weekly servings of fish or seafood (at least one serving of fatty fish); f) ≥3 weekly serving of nuts or seeds; g) select white instead of red meats or processed meats (burgers, sausages); h) cook at least twice a week with a tomato herb sauce. Participants will be instructed to eliminate or limit the consumption of the following foods: cream, butter, margarine, cold meat, paté, duck, carbonated and/or sugared beverages, pastries, industrial bakery products and desserts, French fries or potato chips, and out-of-home pre-cooked cakes and sweets. For usual drinkers, the main source of alcohol should be wine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastroduodenal Permeability	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)	Week 1; Week 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Small Intestinal Permeability	The change in lactulose/rhamnose concentrations in a 5-hour urine collection (end of intervention minus baseline)	Week 1; Week 5
Colonic Permeability	The change in sucralose/erythritol concentrations in a 5 to 24 hour urine collection (end of intervention minus baseline)	Week 1; Week 5
Whole Gut Permeability	The change in sucralose/erythritol concentrations in a 0 to 24 hour urine collection (end of intervention minus baseline)	Week 1; Week 5
Stool Frequency	Difference in the average number of weekly stools (end of intervention compared to baseline)	Week 1; Week 5
Stool Consistency	Daily GI symptoms assessed using the Bristol Stool Scale (BSS). Difference in the average BSS (end of intervention compared to baseline).	Week 1; Week 5
Gastrointestinal Symptoms	Weekly GI symptoms assessed using the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS consists of 15 questions related to 5 syndromes, constipation, diarrhea, reflux, abdominal pain, and indigestion. Symptoms are scored 1=no discomfort to 7=very severe discomfort. Scores from each of the 15 questions are summed for the total GSRS score.	Week 1; Week 5

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Bobbi Langkamp-Henken, PhD, RD, Univeristy of Florida

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Actual): November 13, 2019
• Study Completion (Actual): May 3, 2021

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (Actual): February 22, 2019

Study Record Updates

• Last Update Posted (Actual): May 4, 2021
• Last Update Submitted That Met QC Criteria: May 3, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Mediterranean Diet; Intestinal Permeability; Leaky Gut; Intestinal Barrier Function
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: IRB201900252; OCR20178 (Other Identifier: UF OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No