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Completed

NCT Number: NCT03851861

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

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.

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Key information

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Gastroduodenal Permeability

    Time frame: Week 1; Week 5

    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)

Secondary outcomes

  1. Small Intestinal Permeability

    Time frame: Week 1; Week 5

    The change in lactulose/rhamnose concentrations in a 5-hour urine collection (end of intervention minus baseline)

  2. Colonic Permeability

    Time frame: Week 1; Week 5

    The change in sucralose/erythritol concentrations in a 5 to 24 hour urine collection (end of intervention minus baseline)

  3. Whole Gut Permeability

    Time frame: Week 1; Week 5

    The change in sucralose/erythritol concentrations in a 0 to 24 hour urine collection (end of intervention minus baseline)

  4. Stool Frequency

    Time frame: Week 1; Week 5

    Difference in the average number of weekly stools (end of intervention compared to baseline)

  5. Stool Consistency

    Time frame: Week 1; Week 5

    Daily GI symptoms assessed using the Bristol Stool Scale (BSS). Difference in the average BSS (end of intervention compared to baseline).

  6. Gastrointestinal Symptoms

    Time frame: Week 1; Week 5

    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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Acronym: MED

Important dates

Study start
2019
Primary completion
2019
Study completion
2021
First posted
Feb 22, 2019
Registry last updated
May 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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