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

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ClinicalTrials.gov Identifier: NCT03851861
Recruitment Status : Not yet recruiting
First Posted : February 22, 2019
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Mediterranean Diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Dietary Intervention and Gastrointestinal Function in Patients With Parkinson's Disease
Estimated Study Start Date : March 11, 2019
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. Gastroduodenal Permeability [ Time Frame: Week 1; Week 5 ]
    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 :
  1. Small Intestinal Permeability [ Time Frame: Week 1; Week 5 ]
    The change in lactulose/rhamnose concentrations in a 5-hour urine collection (end of intervention minus baseline)

  2. Colonic Permeability [ Time Frame: Week 1; Week 5 ]
    The change in sucralose/erythritol concentrations in a 5 to 24 hour urine collection (end of intervention minus baseline)

  3. Whole Gut Permeability [ Time Frame: Week 1; Week 5 ]
    The change in sucralose/erythritol concentrations in a 0 to 24 hour urine collection (end of intervention minus baseline)

  4. Stool Frequency [ Time Frame: Week 1; Week 5 ]
    Difference in the average number of weekly stools (end of intervention compared to baseline)

  5. Stool Consistency [ Time Frame: Week 1; Week 5 ]
    Daily GI symptoms assessed using the Bristol Stool Scale (BSS). Difference in the average BSS (end of intervention compared to baseline).

  6. Gastrointestinal Symptoms [ Time Frame: Week 1; Week 5 ]
    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.



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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03851861


Contacts
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Contact: Carley Rusch, MS, RDN, LDN 352-340-7321 nutrition-study@ufl.edu

Locations
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United States, Florida
University of Florida Not yet recruiting
Gainesville, Florida, United States, 32611
Contact: Carley Rusch, MS, RDN, LDN    352-340-7321    nutrition-study@ufl.edu   
Principal Investigator: Bobbi Langkamp-Henken, PhD, RD         
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Bobbi Langkamp-Henken, PhD, RD Univeristy of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03851861     History of Changes
Other Study ID Numbers: IRB201900252
OCR20178 ( Other Identifier: UF OnCore )
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Intestinal Permeability
Mediterranean Diet
Leaky Gut
Intestinal Barrier Function

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases