Parkinson DiseaseMEDI-PDNCT04683900
Mediterranean Diet Intervention to Improve Gastrointestinal Function in Parkinson's Disease a Randomized, Controlled, Clinical Trial
A study of Parkinson Disease, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson Disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2021to 7 Jun 2022
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mediterranean Diet Intervention to Improve Gastrointestinal Function in Parkinson's Disease: a Randomized, Controlled, Clinical Trial
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
- Being tested
- Standard of care + Mediterranean diet (intervention), Standard of care (control)
- Keywords
- Mediterranean diet, Microbiome, Constipation, Inflammation
- Medical subject headings
- Parkinson Disease, Constipation, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 (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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard of care (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
GSRS Constipation Syndrome Score
The difference between mean change (final - baseline) in constipation syndrome scores for the Med diet versus control diet.
Measured: 10 weeks
Secondary outcomes (8)
Stool Frequency
Compare the number of stools between the intervention and control groups
Measured: Each week up to 10 weeks
Stool Form
Compare stool form, as measured by the Bristol Stool Form Scale (BSFS), between the intervention and control groups. The BSFS is scored between 1 (hard stool) - 7 (liquid stool).
Measured: Each day up to 10 weeks
Laxative Usage
Compare number of days using laxative medications between the intervention and control groups.
Measured: Each week up to 10 weeks
Digestive Health
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: Every week up to 10 weeks
Quality of Life Related to Digestive Health
Weekly GI experiences assessed using an in-house Digestion-Associated Quality of Life questionnaire.
Measured: Every week up to 10 weeks
Fecal Microbial Diversity
Changes in fecal microbial composition and diversity (i.e. alpha and beta diversity) will be assessed.
Measured: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)
Fecal Microbial Quantitative Polymerase Chain Reaction (qPCR)
Changes in fecal microbial composition to quantify bacterial species of interest (e.g., F. prausnitzii, Prevotella, Roseburia, Bilophila, Akkermansia, etc.) will be assessed.
Measured: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)
Intestinal Inflammation and Permeability
Changes in fecal calprotectin and zonulin will be assessed using enzyme-linked immunosorbent assay
Measured: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start8 Feb 2021
- Primary completion7 Jun 2022
- Study completion7 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, double-blind, controlled parallel study in which participants either follow a Mediterranean diet or their habitual diet for an 8-week intervention.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bobbi Langkamp-Henken, PhD, RD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683900
- Sponsor's protocol ID
- IRB202001333
- Acronym
- MEDI-PD
- Status last verified
- Jul 2022
- First submitted
- 17 Dec 2020
- Last updated
- 12 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The anonymized datasets used and/or analyzed during the study will be available from the corresponding author upon reasonable request and approval of the University of Florida.
Publications
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.
PubMed 34551955
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediterranean Diet Intervention to Improve Gastrointestinal Function in Parkinson's Disease: a Randomized, Controlled, Clinical Trial
- ClinicalTrials.gov ID
- NCT04683900
- Acronym / sponsor ID
- MEDI-PD / IRB202001333
- Conditions
- Parkinson Disease
- Keywords
- Mediterranean diet, Microbiome, Constipation, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 7 Jun 2022 (actual)
- Study completion
- 7 Jun 2022 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, double-blind, controlled parallel study in which participants either follow a Mediterranean diet or their habitual diet for an 8-week intervention.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care + Mediterranean Diet | Experimental | Other: Standard of care + Mediterranean diet (intervention)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. |
| Standard of Care | Active comparator | Other: Standard of care (control)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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care + Mediterranean diet (intervention)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. | Other | Standard of Care + Mediterranean Diet |
| Standard of care (control)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. | Other | Standard of Care |
Primary outcome
GSRS Constipation Syndrome Score
Time frame: 10 weeks
The difference between mean change (final - baseline) in constipation syndrome scores for the Med diet versus control diet.
8 secondary outcomes
Stool Frequency
Time frame: Each week up to 10 weeks
Stool Form
Time frame: Each day up to 10 weeks
Laxative Usage
Time frame: Each week up to 10 weeks
Digestive Health
Time frame: Every week up to 10 weeks
Quality of Life Related to Digestive Health
Time frame: Every week up to 10 weeks
Fecal Microbial Diversity
Time frame: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)
Fecal Microbial Quantitative Polymerase Chain Reaction (qPCR)
Time frame: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)
Intestinal Inflammation and Permeability
Time frame: Baseline (Week 0); Midpoint (Week 4); Final (Week 8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Derived from this study: PubMed 34551955Rusch 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.
- Individual participant dataSharing planned: Yes. The anonymized datasets used and/or analyzed during the study will be available from the corresponding author upon reasonable request and approval of the University of Florida.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bobbi Langkamp-Henken, PhD, RD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of 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 13 inclusion and 7 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 12 Jul 2022. 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?
GSRS Constipation Syndrome Score (time frame: 10 weeks). 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 NCT04683900, 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 12 Jul 2022.