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
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Other: Mediterranean Diet||Not Applicable|
|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|
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.
- 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)
- 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)
- 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)
- 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)
- Stool Frequency [ Time Frame: Week 1; Week 5 ]Difference in the average number of weekly stools (end of intervention compared to baseline)
- 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).
- 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.
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
|Contact: Carley Rusch, MS, RDN, LDNfirstname.lastname@example.org|
|United States, Florida|
|University of Florida||Not yet recruiting|
|Gainesville, Florida, United States, 32611|
|Contact: Carley Rusch, MS, RDN, LDN 352-340-7321 email@example.com|
|Principal Investigator: Bobbi Langkamp-Henken, PhD, RD|
|Principal Investigator:||Bobbi Langkamp-Henken, PhD, RD||Univeristy of Florida|