High Fiber Supplement for Parkinson's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a high-fiber supplement can affect the gut environment in people with Parkinson's disease. Researchers aim to understand how bacteria, viruses, and fungi in the body might change with this supplement and whether these changes can benefit the brain. They will compare results from people with Parkinson's to those without the disease. Individuals with Parkinson's who haven't started treatment yet might be a good fit for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new supplement.
Will I have to stop taking my current medications?
The trial requires that participants with Parkinson's disease be untreated, meaning you would need to stop any current Parkinson's medications. Additionally, you cannot have used anti-inflammatory medications within 3 weeks before joining the trial.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research shows that prebiotic fiber supplements are generally safe and well-tolerated for people with Parkinson's disease. Studies indicate that these supplements can improve gut health without causing serious side effects. One study found that eating one fiber bar a day for four weeks was safe for people with Parkinson's.
However, some types of fiber, like psyllium, might cause issues, especially with constipation, which is common in Parkinson’s. This trial focuses on a high-fiber supplement, so these specific risks might not apply, but it's important to keep them in mind. Overall, evidence suggests that high-fiber supplements are generally well-tolerated in people.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for Parkinson's disease, which often focus on managing symptoms with medication like levodopa or dopamine agonists, the high fiber supplement targets gut health. Researchers are excited about this because there's growing evidence suggesting a link between gut health and neurological conditions. By improving digestion and potentially influencing the gut-brain connection, this supplement offers a new avenue for managing Parkinson's symptoms. This innovative approach could complement existing therapies, providing a more holistic way to improve patients' quality of life.
What evidence suggests that this high fiber supplement might be an effective treatment for Parkinson's disease?
Research has shown that a high-fiber diet is linked to a lower risk of developing Parkinson's disease. In this trial, some participants will receive a high-fiber supplement, believed to benefit gut health. Prebiotic fiber supplements, known to support gut health, are safe for people with Parkinson's and can lead to positive changes in their gut bacteria. Early findings suggest that these supplements might increase certain beneficial substances in the gut, potentially aiding in managing Parkinson's symptoms. Overall, promising evidence indicates that increased fiber intake can support better health in people with Parkinson's by improving gut health.12456
Who Is on the Research Team?
Gian Pal
Principal Investigator
Rutgers University
Are You a Good Fit for This Trial?
This trial is for Parkinson's disease patients who haven't started treatment. It excludes those with significant GI issues affecting motility, acute illnesses needing hospitalization, alcohol misuse, transplant recipients, diabetes, obesity (BMI > 30), dehydration or edema, short bowel syndrome or severe malnutrition, recent use of immunosuppressants or anti-inflammatories, chronic diuretic use, certain occupations like sanitation workers that affect the microbiome; people on parkinsonism-inducing meds; recent antibiotic users; inflammatory bowel disease sufferers; and those with serious liver/kidney/psychiatric/lung diseases or heart failure.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a high-fiber nutritional supplement to study its effects on the microbiome
Follow-up
Participants are monitored for changes in microbiome composition and health outcomes after treatment
What Are the Treatments Tested in This Trial?
Interventions
- High Fiber supplement
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rutgers, The State University of New Jersey
Lead Sponsor