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This is a 10-week randomized, controlled study to investigate the effect of a Mediterranean diet intervention on gastrointestinal function in Parkinson's disease. After a 2-week run-in period, participants will be instructed to receive standard of care for constipation or receive standard of care + follow a Mediterranean diet for 8 weeks and answer daily and weekly questionnaires. Nutritional and neurological evaluations and stool samples will be collected at 0, 4 and 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care + Mediterranean Diet | Experimental | Participants will be given standard of care for constipation (handout) plus individualized diet education on the Mediterranean diet and instructed to follow the diet during the 8-week intervention period. Diet education will be administered by a study dietitian and followed with weekly phone calls to ensure compliance, improve adherence to the diet and monitor for adverse events. |
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| Standard of Care | Active Comparator | Participants will be given standard of care for constipation (handout) to utilize during the 8-week intervention period. A study dietitian will follow up with weekly phone calls to support adherence and monitor for adverse events. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of care + Mediterranean diet (intervention) | Other | Participants will receive a constipation management handout that is distributed regularly to patients who present with constipation symptoms at an outpatient neurology clinic. The handout recommends increasing fluids daily, as well as increasing physical activity and dietary fiber intake. Laxative medications and recommendations for usage are included. Participants will be instructed to include the following in their diet: a) abundant use of olive oil for cooking and dressing dishes; b) consume ≥2 daily servings of vegetables; c) ≥2-3 daily serving of fruits; d) ≥3 weekly servings of legumes; e) ≥3 weekly servings of fish/seafood; f) ≥3 weekly serving of nuts/seeds; g) select white instead of red or processed meats; h) cook at least twice a week with sofrito. Limit consumption of cream, butter, processed meat, sugared beverages, industrial bakery products and desserts, and French fries or chips. For usual drinkers, the main source of alcohol should be wine. |
| Measure | Description | Time Frame |
|---|---|---|
| GSRS Constipation Syndrome Score | The difference between mean change (final - baseline) in constipation syndrome scores for the Med diet versus control diet. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Stool Frequency | Compare the number of stools between the intervention and control groups | Each week up to 10 weeks |
| Stool Form | Compare stool form, as measured by the Bristol Stool Form Scale (BSFS), between the intervention and control groups. The BSFS is scored between 1 (hard stool) - 7 (liquid stool). |
| Measure | Description | Time Frame |
|---|---|---|
| Mediterranean diet adherence | Compare Mediterranean diet adherence scores using the 14-Item Mediterranean diet adherence screener (MEDAS) between groups | Each week up to 10 weeks |
| Dietary Fiber Intake |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bobbi Langkamp-Henken, PhD, RD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34551955 | Derived | Rusch C, Beke M, Tucciarone L, Dixon K, Nieves C Jr, Mai V, Stiep T, Tholanikunnel T, Ramirez-Zamora A, Hess CW, Langkamp-Henken B. Effect of a Mediterranean diet intervention on gastrointestinal function in Parkinson's disease (the MEDI-PD study): study protocol for a randomised controlled trial. BMJ Open. 2021 Sep 22;11(9):e053336. doi: 10.1136/bmjopen-2021-053336. |
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The anonymized datasets used and/or analyzed during the study will be available from the corresponding author upon reasonable request and approval of the University of Florida.
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A randomized, double-blind, controlled parallel study in which participants either follow a Mediterranean diet or their habitual diet for an 8-week intervention.
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| Standard of care (control) | Other | Participants will receive a constipation management handout that is distributed regularly to patients who present with constipation symptoms at an outpatient neurology clinic. The handout recommends increasing fluids daily, as well as increasing physical activity and dietary fiber intake. Laxative medications and recommendations for usage are included. |
|
| Each day up to 10 weeks |
| Laxative Usage | Compare number of days using laxative medications between the intervention and control groups. | Each week up to 10 weeks |
| Digestive Health | 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. | Every week up to 10 weeks |
| Quality of Life Related to Digestive Health | Weekly GI experiences assessed using an in-house Digestion-Associated Quality of Life questionnaire. | Every week up to 10 weeks |
| Fecal Microbial Diversity | Changes in fecal microbial composition and diversity (i.e. alpha and beta diversity) will be assessed. | Baseline (Week 0); Midpoint (Week 4); Final (Week 8) |
| Fecal Microbial Quantitative Polymerase Chain Reaction (qPCR) | Changes in fecal microbial composition to quantify bacterial species of interest (e.g., F. prausnitzii, Prevotella, Roseburia, Bilophila, Akkermansia, etc.) will be assessed. | Baseline (Week 0); Midpoint (Week 4); Final (Week 8) |
| Intestinal Inflammation and Permeability | Changes in fecal calprotectin and zonulin will be assessed using enzyme-linked immunosorbent assay | Baseline (Week 0); Midpoint (Week 4); Final (Week 8) |
Changes in dietary fiber intake as measured by averaged 4-day dietary recalls using the Automated Self-Administered 24-hour dietary recall (ASA-24) between groups
| Baseline (Week 0); Midpoint (Week 4); Final (Week 8) |
| Body weight | Changes in body weight between groups | Baseline (Week 0); Midpoint (Week 4); Final (Week 8) |
| Body Composition (Fat Free Mass) | Changes in fat free mass using bio-impedance spectroscopy (BIS) between groups | Baseline (Week 0); Midpoint (Week 4); Final (Week 8) |
| Handgrip strength | Changes in handgrip strength will be assessed using a hand dynamometer between groups | Baseline (Week 0); Midpoint (Week 4); Final (Week 8) |
| Quality of Life (QOL) | Changes in QOL will be assessed using the Parkinson's Disease Quality of life -39 (PDQ-39) | Baseline (Week 0); Midpoint (Week 4); Final (Week 8) |
| Anxiety | Changes in symptoms of anxiety will be assessed using the Hamilton Anxiety Rating Scale | Baseline (Week 0); Midpoint (Week 4); Final (Week 8) |
| Depression | Changes in symptoms of anxiety will be assessed using the Hamilton Depression Rating Scale | Baseline (Week 0); Midpoint (Week 4); Final (Week 8) |
| Physical Activity | Changes in MET minutes will be assessed using the International Physical Activity Questionnaire (IPAQ). | Baseline (Week 0); Midpoint (Week 4); Final (Week 8) |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D003248 | Constipation |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D038441 | Diet, Mediterranean |
| D008722 | Methods |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D008919 | Investigative Techniques |
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