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

NCT ID: NCT03851861

Last Updated: 2021-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2021-05-03

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Mediterranean Diet

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.

Group Type: EXPERIMENTAL

Mediterranean Diet

Intervention Type: 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.

Interventions

Mediterranean Diet

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bobbi Langkamp-Henken, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35002935 (View on PubMed)

Other Identifiers

OCR20178

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201900252

Identifier Type: -

Identifier Source: org_study_id