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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
46
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.
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.
University of Florida
Gainesville, Florida, United States
GSRS Constipation Syndrome Score
The difference between mean change (final - baseline) in constipation syndrome scores for the Med diet versus control diet.
Time frame: 10 weeks
Stool Frequency
Compare the number of stools between the intervention and control groups
Time frame: 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).
Time frame: Each day up to 10 weeks
Laxative Usage
Compare number of days using laxative medications between the intervention and control groups.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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
Time frame: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)