Clinical trial NCT04683900: Mediterranean Diet Intervention to Improve Gastrointestinal Function in Parkinson's Disease a Randomized, Controlled, Clinical Trial
Official title: Mediterranean Diet Intervention to Improve Gastrointestinal Function in Parkinson's Disease: a Randomized, Controlled, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Mediterranean diet
Microbiome
Constipation
Inflammation
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 46
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, double-blind, controlled parallel study in which participants either follow a Mediterranean diet or their habitual diet for an 8-week intervention.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Physician-diagnosed Parkinson's disease aged 40-85 years
* Drug naïve or on stable dosage of Parkinson's medications with no plans to change for the duration of the study protocol
* Hoehn \& Yahr stage =\<2.5 in the clinical "ON" state
* Constipation syndrome scores \>=2.0 based on the GSRS
* Consume \<20 grams of fiber daily based on the Block Fruit/Vegetable/Fiber screener
* Able to complete informed consent in English
* Willing to maintain habitual diet through the pre-baseline period.
* Willing to make dietary changes to follow a Mediterranean diet and/or receive standard of care for constipation during the intervention period.
* Willing to complete daily and weekly questionnaires and 12 dietary recalls over approximately 10 weeks.
* Able to provide stool samples during the study collection periods.
* Willing to avoid strenuous exercise and alcohol such as beer, wine, and cocktails 24 hours prior to each of the 3 study visits.
* Able to fast (no food or drink, except water, or decaf tea) at least 12 hours before each study visit
* Willing to discontinue taking prebiotic, herbal, or high-dose vitamin or mineral supplements that may impact inflammation during the pre-baseline period and throughout the study protocol.

Exclusion Criteria:

* Atypical or secondary Parkinsonism
* Underweight (BMI \<18.5)
* History of deep brain stimulation (DBS) surgery
* Regular use of enemas or suppositories to alleviate constipation (e.g., \>1 time per week)
* Use of another investigational product within 3 months of the screening visit
* Antibiotic or probiotic supplement use within 2 months from the day of stool collection
* Currently being treated for a physician-diagnosed GI disease or condition other than constipation, irritable bowel disease, gastroparesis, reflux or diverticular disease

Primary outcomes:
measure: GSRS Constipation Syndrome Score
timeFrame: 10 weeks
Secondary outcomes:
measure: Stool Frequency
timeFrame: Each week up to 10 weeks
measure: Stool Form
timeFrame: Each day up to 10 weeks
measure: Laxative Usage
timeFrame: Each week up to 10 weeks
measure: Digestive Health
timeFrame: Every week up to 10 weeks
measure: Quality of Life Related to Digestive Health
timeFrame: Every week up to 10 weeks
measure: Fecal Microbial Diversity
timeFrame: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)
measure: Fecal Microbial Quantitative Polymerase Chain Reaction (qPCR)
timeFrame: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)
measure: Intestinal Inflammation and Permeability
timeFrame: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)
Other outcomes:
measure: Mediterranean diet adherence
timeFrame: Each week up to 10 weeks
measure: Dietary Fiber Intake
timeFrame: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)
measure: Body weight
timeFrame: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)
measure: Body Composition (Fat Free Mass)
timeFrame: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)
measure: Handgrip strength
timeFrame: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)
measure: Quality of Life (QOL)
timeFrame: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)
measure: Anxiety
timeFrame: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)
measure: Depression
timeFrame: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)
measure: Physical Activity
timeFrame: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Bobbi Langkamp-Henken, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.