60 Participants Needed

High Fiber Supplement for Parkinson's Disease

GP
Overseen ByGian Pal, MD, MS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

What data supports the effectiveness of the high fiber supplement treatment for Parkinson's disease?

Research shows that a diet rich in insoluble fiber can improve motor function and increase the effectiveness of L-dopa, a common Parkinson's medication, by improving constipation. Additionally, psyllium, a type of fiber, has been shown to improve constipation in Parkinson's patients, and prebiotic fibers have been associated with beneficial changes in gut health and inflammation in these patients.12345

Is the high fiber supplement safe for humans?

Research shows that prebiotic fiber supplements are generally safe and well-tolerated in people with Parkinson's disease, leading to beneficial changes in gut bacteria and other health markers.12346

How does the high fiber supplement treatment for Parkinson's disease differ from other treatments?

The high fiber supplement treatment for Parkinson's disease is unique because it focuses on improving gut health and increasing the bioavailability of L-dopa, a common Parkinson's medication, by addressing constipation, a frequent non-motor symptom in Parkinson's patients. Unlike traditional treatments that primarily target motor symptoms, this approach uses dietary fiber to enhance gut microbiota and short-chain fatty acid production, potentially offering additional benefits beyond symptom management.12456

What is the purpose of this trial?

This trial is testing a high-fiber supplement to see if it can change the microorganisms in people with Parkinson's disease and study how these changes might affect brain health.

Research Team

GP

Gian Pal

Principal Investigator

Rutgers University

Eligibility Criteria

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

I have Parkinson's disease and have not received any treatment.

Exclusion Criteria

Occupation expected to change the microbiome (e.g. sanitation worker)
I have been diagnosed with inflammatory bowel disease.
I am not taking medications that can cause Parkinson-like symptoms.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a high-fiber nutritional supplement to study its effects on the microbiome

8 weeks

Follow-up

Participants are monitored for changes in microbiome composition and health outcomes after treatment

4 weeks

Treatment Details

Interventions

  • High Fiber supplement
Trial Overview The study tests a high-fiber supplement's impact on body microorganisms in Parkinson's patients compared to healthy individuals. It also explores how stool transplants into mice might influence brain health related to Parkinson-like conditions. The goal is to understand if altering the microbiome can benefit humans.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Parkinson's patientsExperimental Treatment1 Intervention
Parkinson's patients who will receive a high fiber supplement
Group II: Control subjectsActive Control1 Intervention
no supplement will be given

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials
471
Recruited
81,700+

References

Clinical and pharmacokinetic effects of a diet rich in insoluble fiber on Parkinson disease. [2019]
Constipation in Parkinson's disease: objective assessment and response to psyllium. [2006]
Dietary intake and olfactory function in patients with newly diagnosed Parkinson's disease: a case-control study. [2013]
An open label, non-randomized study assessing a prebiotic fiber intervention in a small cohort of Parkinson's disease participants. [2023]
Mediterranean Diet Adherence in People With Parkinson's Disease Reduces Constipation Symptoms and Changes Fecal Microbiota After a 5-Week Single-Arm Pilot Study. [2022]
Parkinson's disease patients' short chain fatty acids production capacity after in vitro fecal fiber fermentation. [2023]
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