High Fiber Supplement for Parkinson's Disease

Overseen By Gian Pal, MD, MS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Antipsychotics, Antibiotics, Immunosuppressives, others

Disqualifiers: Inflammatory bowel disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

60 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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. ^{1 2 4 5 6}

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

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.

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

Group I: Parkinson's patients Experimental Treatment 1 Intervention

Parkinson's patients who will receive a high fiber supplement

Group II: Control subjects Active Control 1 Intervention

no supplement will be given

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical and pharmacokinetic effects of a diet rich in insoluble fiber on Parkinson disease. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Constipation in Parkinson's disease: objective assessment and response to psyllium. [2006]

3. England pubmed.ncbi.nlm.nih.gov

Dietary intake and olfactory function in patients with newly diagnosed Parkinson's disease: a case-control study. [2013]

4. England pubmed.ncbi.nlm.nih.gov

An open label, non-randomized study assessing a prebiotic fiber intervention in a small cohort of Parkinson's disease participants. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

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]

6. United States pubmed.ncbi.nlm.nih.gov

Parkinson's disease patients' short chain fatty acids production capacity after in vitro fecal fiber fermentation. [2023]