Mediterranean Diet Intervention to Improve Gastrointestinal Function in Parkinson's Disease a Randomized, Controlled, Clinical Trial

NCT04683900 | Completed

• 1 other identifier: IRB202001333
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Mediterranean diet; Microbiome; Constipation; Inflammation

Outcome Measures

Primary Outcomes (1)

• GSRS Constipation Syndrome Score

  The difference between mean change (final - baseline) in constipation syndrome scores for the Med diet versus control diet.

  10 weeks

Secondary Outcomes (8)

• Stool Frequency

  Each week up to 10 weeks

• Stool Form

  Each day up to 10 weeks

• Laxative Usage

  Each week up to 10 weeks

• Digestive Health

  Every week up to 10 weeks

• Quality of Life Related to Digestive Health

  Every week up to 10 weeks

Other Outcomes (9)

• Mediterranean diet adherence

  Each week up to 10 weeks

• Dietary Fiber Intake

  Baseline (Week 0); Midpoint (Week 4); Final (Week 8)

• Body weight

  Baseline (Week 0); Midpoint (Week 4); Final (Week 8)

Study Arms (2)

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.

Other: Standard of care + Mediterranean diet (intervention)

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.

Other: Standard of care (control)

Interventions

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.

Standard of Care + Mediterranean Diet

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.

Standard of Care

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (1)

• 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.

  PMID: 34551955 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Constipation; Inflammation

Interventions

Standard of Care; Diet, Mediterranean; Methods

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Investigative Techniques

Study Officials

• Bobbi Langkamp-Henken, PhD, RD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, double-blind, controlled parallel study in which participants either follow a Mediterranean diet or their habitual diet for an 8-week intervention.

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 24, 2020
• Study Start: February 8, 2021
• Primary Completion: June 7, 2022
• Study Completion: June 7, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)