Resistant Maltodextrin for Parkinson's Disease

Overseen By Rachel Lewandowski

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Northwestern University

Must be taking: PD medications

Must not be taking: Antibiotics, Laxatives

Disqualifiers: Diabetes, Cognitive impairment, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial will test if a special type of dietary fiber called resistant maltodextrin is safe and can help improve gut health and symptoms in people with Parkinson's disease. The fiber works by feeding good bacteria in the gut.

Will I have to stop taking my current medications?

You will need to stay on a stable dose of your Parkinson's disease medications and any melatonin, sedative, or stimulant medications you are using for the duration of the study. However, you cannot use prebiotic or probiotic treatments, laxatives, or antibiotics during the study.

How does resistant maltodextrin treatment differ from other treatments for Parkinson's disease?

Resistant maltodextrin is unique because it acts as a prebiotic, which means it helps beneficial gut bacteria grow, potentially increasing short-chain fatty acids (SCFAs) that are often reduced in Parkinson's disease. This approach focuses on improving gut health and reducing inflammation, which is different from traditional treatments that primarily target motor symptoms. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Resistant Maltodextrin for Parkinson's Disease?

Research shows that a similar treatment, resistant starch, increased beneficial gut compounds and reduced inflammation markers in Parkinson's patients, leading to a decrease in non-motor symptoms. This suggests that resistant maltodextrin might also help improve symptoms by positively affecting gut health. ^{3 5 6 7 8}

Who Is on the Research Team?

Roneil G Malkani

Principal Investigator

Northwestern Feinberg School of Medicine Department of Neurology

Are You a Good Fit for This Trial?

This trial is for men and women aged 60 or older with Parkinson's Disease (PD), who have been on a stable dose of PD medications for at least 30 days. They should be in the early to mid-stages of PD and not have diabetes, unstable health conditions, recent laxative use, cognitive impairment, or be taking certain other treatments.

Inclusion Criteria

My Parkinson's disease medication dose has been stable for the last 30 days.

I am 60 years old or older.

I have Parkinson's disease at a mild to moderate stage.

Exclusion Criteria

I have not used any prebiotic or probiotic treatments in the last 30 days.

I have used laxatives in the last 3 weeks.

Use of antibiotics in the past 30 days

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive resistant maltodextrin or maltodextrin for 4 weeks, starting with 25g daily for 1 week and then 50g daily for the remaining 3 weeks

4 weeks

Weekly in-person visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Maltodextrin
• Resistant maltodextrin

Trial Overview The study tests the safety and effects of resistant maltodextrin, a dietary fiber, on gut health and Parkinson's symptoms compared to regular maltodextrin. Participants are randomly assigned to one of these two groups to see if there are any differences.

How Is the Trial Designed?

Group I: Resistant Maltodextrin Experimental Treatment 1 Intervention

Resistant maltodextrin (RM) powder 25 g during days 1-7 and 50g during days 8-28, each dose dissolved in 8 oz of water once daily in the morning.

Group II: Maltodextrin Placebo Group 1 Intervention

Maltodextrin 25g for days 1-7 and 50 g for days 8-28, each dose dissolved in 8 oz of water once daily in the morning.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+

Citations

1. China pubmed.ncbi.nlm.nih.gov

Effects of Resistant Starch on Symptoms, Fecal Markers, and Gut Microbiota in Parkinson's Disease - The RESISTA-PD Trial. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Intestinal Decontamination Therapy for Dyskinesia and Motor Fluctuations in Parkinson's Disease. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Clinical and pharmacokinetic effects of a diet rich in insoluble fiber on Parkinson disease. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Restoration of intestinal function in an MPTP model of Parkinson's Disease. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplant as a potential treatment for Parkinson's disease - A case series. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Fiber deprivation and microbiome-borne curli shift gut bacterial populations and accelerate disease in a mouse model of Parkinson's disease. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Dairy foods intake and risk of Parkinson's disease: a dose-response meta-analysis of prospective cohort studies. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Curcumin Treatment Improves Motor Behavior in α-Synuclein Transgenic Mice. [2020]