Back to resultsMediterranean Diet Intervention to Improve Gastrointestinal Function in Parkinson's Disease a Randomized, Controlled, Clinical Trial (MEDI-PD)
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of care + Mediterranean diet (intervention)
Standard of care (control)
Sponsored by
About this trial
This is an interventional basic science trial for Parkinson Disease focused on measuring Mediterranean diet, Microbiome, Constipation, Inflammation
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
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Standard of Care + Mediterranean Diet
Standard of Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
GSRS Constipation Syndrome Score
The difference between mean change (final - baseline) in constipation syndrome scores for the Med diet versus control diet.
Secondary Outcome Measures
Stool Frequency
Compare the number of stools between the intervention and control groups
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).
Laxative Usage
Compare number of days using laxative medications between the intervention and control groups.
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.
Quality of Life Related to Digestive Health
Weekly GI experiences assessed using an in-house Digestion-Associated Quality of Life questionnaire.
Fecal Microbial Diversity
Changes in fecal microbial composition and diversity (i.e. alpha and beta diversity) will be assessed.
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.
Intestinal Inflammation and Permeability
Changes in fecal calprotectin and zonulin will be assessed using enzyme-linked immunosorbent assay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04683900
Brief Title
Mediterranean Diet Intervention to Improve Gastrointestinal Function in Parkinson's Disease a Randomized, Controlled, Clinical Trial
Acronym
MEDI-PD
Official Title
Mediterranean Diet Intervention to Improve Gastrointestinal Function in Parkinson's Disease: a Randomized, Controlled, Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 8, 2021 (Actual)
Primary Completion Date
June 7, 2022 (Actual)
Study Completion Date
June 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Mediterranean diet, Microbiome, Constipation, Inflammation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care + Mediterranean Diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of care + Mediterranean diet (intervention)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of care (control)
Intervention Description
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.
Primary Outcome Measure Information:
Title
GSRS Constipation Syndrome Score
Description
The difference between mean change (final - baseline) in constipation syndrome scores for the Med diet versus control diet.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Stool Frequency
Description
Compare the number of stools between the intervention and control groups
Time Frame
Each week up to 10 weeks
Title
Stool Form
Description
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
Title
Laxative Usage
Description
Compare number of days using laxative medications between the intervention and control groups.
Time Frame
Each week up to 10 weeks
Title
Digestive Health
Description
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
Title
Quality of Life Related to Digestive Health
Description
Weekly GI experiences assessed using an in-house Digestion-Associated Quality of Life questionnaire.
Time Frame
Every week up to 10 weeks
Title
Fecal Microbial Diversity
Description
Changes in fecal microbial composition and diversity (i.e. alpha and beta diversity) will be assessed.
Time Frame
Baseline (Week 0); Midpoint (Week 4); Final (Week 8)
Title
Fecal Microbial Quantitative Polymerase Chain Reaction (qPCR)
Description
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)
Title
Intestinal Inflammation and Permeability
Description
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)
Other Pre-specified Outcome Measures:
Title
Mediterranean diet adherence
Description
Compare Mediterranean diet adherence scores using the 14-Item Mediterranean diet adherence screener (MEDAS) between groups
Time Frame
Each week up to 10 weeks
Title
Dietary Fiber Intake
Description
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
Time Frame
Baseline (Week 0); Midpoint (Week 4); Final (Week 8)
Title
Body weight
Description
Changes in body weight between groups
Time Frame
Baseline (Week 0); Midpoint (Week 4); Final (Week 8)
Title
Body Composition (Fat Free Mass)
Description
Changes in fat free mass using bio-impedance spectroscopy (BIS) between groups
Time Frame
Baseline (Week 0); Midpoint (Week 4); Final (Week 8)
Title
Handgrip strength
Description
Changes in handgrip strength will be assessed using a hand dynamometer between groups
Time Frame
Baseline (Week 0); Midpoint (Week 4); Final (Week 8)
Title
Quality of Life (QOL)
Description
Changes in QOL will be assessed using the Parkinson's Disease Quality of life -39 (PDQ-39)
Time Frame
Baseline (Week 0); Midpoint (Week 4); Final (Week 8)
Title
Anxiety
Description
Changes in symptoms of anxiety will be assessed using the Hamilton Anxiety Rating Scale
Time Frame
Baseline (Week 0); Midpoint (Week 4); Final (Week 8)
Title
Depression
Description
Changes in symptoms of anxiety will be assessed using the Hamilton Depression Rating Scale
Time Frame
Baseline (Week 0); Midpoint (Week 4); Final (Week 8)
Title
Physical Activity
Description
Changes in MET minutes will be assessed using the International Physical Activity Questionnaire (IPAQ).
Time Frame
Baseline (Week 0); Midpoint (Week 4); Final (Week 8)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bobbi Langkamp-Henken, PhD, RD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
34551955
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.
Results Reference
derived
Learn more about this trial
Mediterranean Diet Intervention to Improve Gastrointestinal Function in Parkinson's Disease a Randomized, Controlled, Clinical Trial
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