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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 below
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I am 60 years old or older.
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I have Parkinson's disease at a mild to moderate stage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

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.

Find a Location

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

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
~5 spots leftby Mar 2025