University of Florida
Gainesville, Florida, 32611, United States
NCT Number: NCT03851861
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.
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Notify Me21 year–85 year
All sexes
Interventional
Not applicable
Gainesville, Florida, 32611, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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)
Time frame: Week 1; Week 5
The change in lactulose/rhamnose concentrations in a 5-hour urine collection (end of intervention minus baseline)
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)
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)
Time frame: Week 1; Week 5
Difference in the average number of weekly stools (end of intervention compared to baseline)
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).
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.
University of Florida
Other
Acronym: MED
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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