search
Back to results

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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mediterranean Diet
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson Disease focused on measuring Intestinal Permeability, Mediterranean Diet, Leaky Gut, Intestinal Barrier Function

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.
  • 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

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mediterranean Diet

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Small Intestinal Permeability
The change in lactulose/rhamnose concentrations in a 5-hour urine collection (end of intervention minus baseline)
Colonic Permeability
The change in sucralose/erythritol concentrations in a 5 to 24 hour urine collection (end of intervention minus baseline)
Whole Gut Permeability
The change in sucralose/erythritol concentrations in a 0 to 24 hour urine collection (end of intervention minus baseline)
Stool Frequency
Difference in the average number of weekly stools (end of intervention compared to baseline)
Stool Consistency
Daily GI symptoms assessed using the Bristol Stool Scale (BSS). Difference in the average BSS (end of intervention compared to baseline).
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.

Full Information

First Posted
February 21, 2019
Last Updated
May 3, 2021
Sponsor
University of Florida
search

1. Study Identification

Unique Protocol Identification Number
NCT03851861
Brief Title
Dietary Intervention and Gastrointestinal Function in Patients With Parkinson's Disease
Acronym
MED
Official Title
Dietary Intervention and Gastrointestinal Function in Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
November 13, 2019 (Actual)
Study Completion Date
May 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Intestinal Permeability, Mediterranean Diet, Leaky Gut, Intestinal Barrier Function

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mediterranean Diet
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Mediterranean Diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gastroduodenal Permeability
Description
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)
Time Frame
Week 1; Week 5
Secondary Outcome Measure Information:
Title
Small Intestinal Permeability
Description
The change in lactulose/rhamnose concentrations in a 5-hour urine collection (end of intervention minus baseline)
Time Frame
Week 1; Week 5
Title
Colonic Permeability
Description
The change in sucralose/erythritol concentrations in a 5 to 24 hour urine collection (end of intervention minus baseline)
Time Frame
Week 1; Week 5
Title
Whole Gut Permeability
Description
The change in sucralose/erythritol concentrations in a 0 to 24 hour urine collection (end of intervention minus baseline)
Time Frame
Week 1; Week 5
Title
Stool Frequency
Description
Difference in the average number of weekly stools (end of intervention compared to baseline)
Time Frame
Week 1; Week 5
Title
Stool Consistency
Description
Daily GI symptoms assessed using the Bristol Stool Scale (BSS). Difference in the average BSS (end of intervention compared to baseline).
Time Frame
Week 1; Week 5
Title
Gastrointestinal Symptoms
Description
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.
Time Frame
Week 1; Week 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bobbi Langkamp-Henken, PhD, RD
Organizational Affiliation
Univeristy of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35002935
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs