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| ID | Type | Description | Link |
|---|---|---|---|
| OCR20178 | Other Identifier | UF OnCore |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediterranean Diet | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean Diet | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Small Intestinal Permeability | The change in lactulose/rhamnose concentrations in a 5-hour urine collection (end of intervention minus baseline) | Week 1; Week 5 |
| Colonic Permeability | The change in sucralose/erythritol concentrations in a 5 to 24 hour urine collection (end of intervention minus baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bobbi Langkamp-Henken, PhD, RD | Univeristy of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35002935 | Derived | 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. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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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.
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| Week 1; Week 5 |
| 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 |
| Stool Frequency | Difference in the average number of weekly stools (end of intervention compared to baseline) | Week 1; Week 5 |
| 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 |
| 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 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |