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

Parkinson Disease Clinical Trial

— MED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03851861
• Other study ID #: IRB201900252
• Secondary ID: OCR20178
• Status: Completed
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: May 3, 2021

Study information

• Verified date: May 2021
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 3, 2021
• Est. primary completion date: November 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Small Intestinal Permeability	The change in lactulose/rhamnose concentrations in a 5-hour urine collection (end of intervention minus baseline)	Week 1; Week 5
Secondary	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
Secondary	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
Secondary	Stool Frequency	Difference in the average number of weekly stools (end of intervention compared to baseline)	Week 1; Week 5
Secondary	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
Secondary	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