NCT04976959

High Fiber in Parkinson's Disease

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of the research is to determine the effects of a high-fiber nutritional supplement (HFS) on the bacteria, viruses, and fungi that live in different regions of the body in those with Parkinson's disease (PD). We will compare the bacteria, viruses, and fungi of those with PD to those without PD (healthy controls). We will also examine the effects of transplanting stool from humans into laboratory mice with or without Parkinson-like pathology to understand how the microbiome influences the brains of animals. We can use this information to get a better understanding of how changing the microbiome might help humans.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	High Fiber supplement	The supplement consists of a mixture of soluble fibers (from inulin and fibersol-2) and insoluble fibers (from oat bran, corn bran, wheat bran and sorghum bran) and it will be consumed as a drink.

Timeline

• Start date: 2021-07-08
• Primary completion: 2025-06-30
• Completion: 2025-08-31
• First posted: 2021-07-26
• Last updated: 2024-02-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study