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Dietary Supplement
Resistant maltodextrin for Dietary Modifications
Phase 2
Waitlist Available
Led By Roneil G Malkani
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men and women age ≥60 years
Diagnosis of PD based on United Kingdom PD brain bank criteria, Hoehn and Yahr stage 1-3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Study Summary
This trialstudies how a dietary fiber affects people with Parkinson's, looking at safety, microbiome, and motor/non-motor changes. Half get fiber, half get control.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical concerns with dietary fibers like resistant maltodextrin may include digestive discomfort such as bloating, gas or altered bowel habits.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 60 years old or older.
Select...
I have Parkinson's disease at a mild to moderate stage.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events
Secondary outcome measures
Gut microbial remodeling
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Resistant MaltodextrinExperimental Treatment1 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: MaltodextrinPlacebo Group1 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.
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,576 Previous Clinical Trials
911,892 Total Patients Enrolled
University of Illinois at ChicagoOTHER
602 Previous Clinical Trials
1,558,481 Total Patients Enrolled
Roneil G MalkaniPrincipal InvestigatorNorthwestern Feinberg School of Medicine Department of Neurology
Frequently Asked Questions
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