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Parkinson DiseaseMEDNCT03851861

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

A study testing Mediterranean Diet in people with Parkinson Disease, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 85 years
Conditions the study is for
Parkinson Disease
What is being tested?
Mediterranean Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
15 Apr 2019to 3 May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Florida

    Gainesville, Florida, 32611

Other trials in United States

About this study

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.

Being tested
Mediterranean Diet
Keywords
Intestinal Permeability, Mediterranean Diet, Leaky Gut, Intestinal Barrier Function
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mediterranean DietOther

    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.

Study groups in NCT03851861
Study groupRoleWhat they receive
Mediterranean DietExperimentalParticipants 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.
Receives: Other: Mediterranean Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Week 1; Week 5

Secondary outcomes (6)

  1. Small Intestinal Permeability

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

    Measured: Week 1; Week 5

  2. Colonic Permeability

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

    Measured: Week 1; Week 5

  3. Whole Gut Permeability

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

    Measured: Week 1; Week 5

  4. Stool Frequency

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

    Measured: Week 1; Week 5

  5. Stool Consistency

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

    Measured: Week 1; Week 5

  6. Gastrointestinal Symptoms

    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.

    Measured: Week 1; Week 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2019
  2. Study start15 Apr 2019
  3. Primary completion13 Nov 2019
  4. Study completion3 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03851861
Sponsor's protocol ID
IRB201900252
Other IDs
OCR20178
Acronym
MED
Status last verified
May 2021
First submitted
21 Feb 2019
Last updated
4 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35002935

Questions about this trial

What is this clinical trial studying?

A study testing Mediterranean Diet in people with Parkinson Disease, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gastroduodenal Permeability (time frame: Week 1; Week 5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03851861, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.

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