Dietary Intervention and Gastrointestinal Function in Patients With Parkinson's Disease

NCT03851861 | Completed

• 2 other identifiers: IRB201900252OCR20178
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective, intervention study, participants with diagnosed Parkinson's disease will be instructed to follow a Mediterranean diet for five weeks. Gut permeability will be assessed using food-grade sugar molecules. Participants will provide urine and stool samples to assess gut permeability and microbial communities.

Conditions

Parkinson Disease

Keywords

Intestinal Permeability; Mediterranean Diet; Leaky Gut; Intestinal Barrier Function

Outcome Measures

Primary Outcomes (1)

• Gastroduodenal Permeability

  The primary outcome is the change in gastroduodenal permeability induced by the Mediterranean diet. Gastroduodenal permeability will be assessed by measuring sucrose concentration in the 0 to 5-hour urine collection (end of intervention minus baseline)

  Week 1; Week 5

Secondary Outcomes (6)

• Small Intestinal Permeability

  Week 1; Week 5

• Colonic Permeability

  Week 1; Week 5

• Whole Gut Permeability

  Week 1; Week 5

• Stool Frequency

  Week 1; Week 5

• Stool Consistency

  Week 1; Week 5

Study Arms (1)

Mediterranean Diet

EXPERIMENTAL

Participants will be given individualized diet education on the Mediterranean diet and instructed to follow the diet for the 5-week intervention period. Individualized diet education will be administered by a licensed, registered dietitian nutritionist (RDN) followed by weekly phone calls to ensure compliance, improve adherence to the diet and monitor for adverse events.

Other: Mediterranean Diet

Interventions

Mediterranean Diet OTHER

Participants will be instructed to include the following in their diet: a) abundant use of olive oil for cooking and dressing dishes; b) consumption of ≥2 daily servings of vegetables; c) ≥2-3 daily serving of fresh fruits (including natural juices); d) ≥3 weekly servings of legumes; e) ≥3 weekly servings of fish or seafood (at least one serving of fatty fish); f) ≥3 weekly serving of nuts or seeds; g) select white instead of red meats or processed meats (burgers, sausages); h) cook at least twice a week with a tomato herb sauce. Participants will be instructed to eliminate or limit the consumption of the following foods: cream, butter, margarine, cold meat, paté, duck, carbonated and/or sugared beverages, pastries, industrial bakery products and desserts, French fries or potato chips, and out-of-home pre-cooked cakes and sweets. For usual drinkers, the main source of alcohol should be wine.

Mediterranean Diet

Eligibility Criteria

• Age: 21 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 21-85 years
• Hoehn \& Yahr stage \<3
• Currently living in the same household with a healthy spouse/partner who meets study eligibility criteria and is willing to participate
• Willing and able to complete informed consent in English
• Willing to complete daily and weekly questionnaires and 6 dietary recalls over approximately 7 weeks
• Willing to avoid beer, wine, and cocktails on the day before and the day of the sugar probe tests.
• Willing to provide urine and stool samples during the study collection periods.
• Willing and able to fast (no food or drink, except water or tea) for a prolonged period of time during study urine collections.
• Willing to maintain usual diet through the pre-baseline period
• Willing to make dietary changes to follow a Mediterranean dietary pattern during the intervention period.
• Willing to discontinue taking prebiotic, fiber, probiotic, herbal, or high-dose vitamin or mineral supplements that may impact inflammation during the pre-baseline period and throughout the study protocol.
• Willing to limit use of oral laxative medication to an "as-needed basis" (i.e. \<3 times per week) during the full length of the study
• Willing to avoid high intensity exercises two days prior to and the day of the permeability tests. These tests will be done on two occasions.
• Willing to provide a social security number to receive study payment.

You may not qualify if:

• Does not meet above criteria
• Atypical or secondary Parkinsonism
• History of deep brain stimulation
• Daily use of NSAIDs in the last 3 months or incidental use in the last 2 weeks prior to screening.
• Daily use of anticholinergics or prokinetic agents
• Use of enemas or suppositories to alleviate constipation
• Use of another investigational product within 3 months of the screening visit.
• Antibiotic use within 2 months from the day of stool collection
• Good adherence to the Mediterranean diet during the pre-baseline period (score \>6) based on the 14-item Mediterranean Diet Assessment Tool
• Physician-diagnosed gastrointestinal disease or condition (such as ulcerative colitis, Crohn's disease, gastroparesis, cancer, peptic ulcer disease, Celiac disease, short bowel disease, ileostomy, colostomy) other than gastroesophageal 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, Nieves C Jr, Ukhanova M, Tagliamonte MS, Mai V, Suh JH, Wang Y, Chiu S, Patel B, Ramirez-Zamora A, Langkamp-Henken B. Mediterranean Diet Adherence in People With Parkinson's Disease Reduces Constipation Symptoms and Changes Fecal Microbiota After a 5-Week Single-Arm Pilot Study. Front Neurol. 2021 Dec 23;12:794640. doi: 10.3389/fneur.2021.794640. eCollection 2021.

  PMID: 35002935 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Bobbi Langkamp-Henken, PhD, RD

  Univeristy of Florida

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: A prospective intervention study in which participants with diagnosed Parkinson's disease are instructed to follow the Mediterranean diet for a 5-week intervention period.

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 22, 2019
• Study Start: April 15, 2019
• Primary Completion: November 13, 2019
• Study Completion: May 3, 2021
• Last Updated: May 4, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)