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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a dietary fiber called resistant maltodextrin might benefit people with Parkinson's disease. Researchers aim to determine the fiber's safety and its effects on gut health, movement, and other symptoms. Participants will receive either resistant maltodextrin or a similar substance, maltodextrin, to compare effects. People with Parkinson's who have stable symptoms and are not using certain supplements or medications may qualify as candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to early findings on its potential benefits.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that resistant maltodextrin, a type of dietary fiber, is under study for safety in people with Parkinson's disease. Earlier studies examined its tolerability, and results suggest it is generally easy to tolerate. As a prebiotic, resistant maltodextrin supports the growth of beneficial gut bacteria. These studies have reported no major safety issues. However, as this is a Phase 2 trial, the treatment continues to undergo testing for safety and effectiveness. The results so far are promising, but further research is needed to confirm them. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's disease?

Researchers are excited about using resistant maltodextrin for Parkinson's disease because it offers a novel approach compared to standard treatments like levodopa and dopamine agonists. Unlike these medications that focus on replacing or mimicking dopamine, resistant maltodextrin is a type of dietary fiber that may influence gut health and, subsequently, brain health through the gut-brain axis. This new mechanism could potentially offer symptom relief with fewer side effects and a different set of benefits. Additionally, its form as a daily powder dissolved in water makes it easy to administer, which can improve patient adherence to the treatment.

What evidence suggests that resistant maltodextrin might be an effective treatment for Parkinson's disease?

This trial will compare resistant maltodextrin with a placebo to evaluate its effects on Parkinson's disease. Research has shown that resistant maltodextrin, a type of dietary fiber, may improve gut health in people with Parkinson's disease. Studies on similar fibers, like resistant starch, have demonstrated an increase in beneficial gut compounds and a decrease in inflammation markers in Parkinson's patients. This suggests that resistant maltodextrin could positively affect the gut microbiome, which is believed to be linked to Parkinson's symptoms. While more research is needed, early signs indicate it might help with movement and other symptoms by promoting a healthier gut environment. ^{1 2 3 4 6}

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.

Use of antibiotics in the past 30 days

I have used laxatives in the last 3 weeks.

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. clinicaltrials.gov clinicaltrials.gov/study/NCT03667404

Resistant Maltodextrin for Gut Microbiome in Parkinson's ... This study will evaluate the safety and tolerability of a dietary fiber, resistant maltodextrin, in people with Parkinson's disease.

2. withpower.com withpower.com/trial/phase-3-parkinson-disease-10-2018-9c2c8

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 ...

3. clinicaltrial.be clinicaltrial.be/en/details/188658?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Resistant Maltodextrin for Gut Microbiome in Parkinson's... The objective of this study is to examine the safety and tolerability of resistant maltodextrin (RM), a prebiotic non-digestible fiber, and its ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10836553/

Dietary Interventions in Parkinson's Disease - PMC Intervention: Participants will either receive 25 g of resistant maltodextrin (RM) powder or maltodextrin powder during days 1-7 and 50 g during days 8-28.

5. researchgate.net researchgate.net/publication/360863409_Resistant_Maltodextrin_Consumption_in_a_Double-Blind_Randomized_Crossover_Clinical_Trial_Induces_Specific_Changes_in_Potentially_Beneficial_Gut_Bacteria

(PDF) Resistant Maltodextrin Consumption in a Double- ... We did not detect any effects of RMD on LAB. Conclusions: RMD supplementation in healthy individuals increases Fusicatenibacter saccharivorans.

6. scholars.northwestern.edu scholars.northwestern.edu/en/projects/gut-microbial-remodeling-with-resistant-maltodextrin-for-motor-an-6/

Gut Microbial Remodeling with Resistant Maltodextrin for ... The primary outcome in this study will be safety and tolerability, and the secondary outcome will be alterations in fecal microbiome. Data from this study will ...