Open Label Single Arm Prebiotic Pilot Trial SR001

A Single Arm, Open Label Study to Assess the Tolerability of a Prebiotic in Adults With Parkinson's Disease and Healthy Adults

The goal of this pilot clinical study is to evaluate the effect of a prebiotic fiber blend in individuals diagnosed with Parkinson's Disease. The main objectives of this pilot study are:

1. To assess the safety and tolerability of consuming 1 fiber bar/day
2. To determine if a prebiotic fiber blend impacts biological metrics and non-motor symptoms of Parkinsons Disease
3. To evaluate the effect of the fiber bar on intestinal inflammation

Participants will have blood and fecal samples collected at baseline and after 4 weeks of intervention. Participants will also complete questionnaires to monitor GI symptom severity, quality of life metrics, and Parkinson's-specific surveys. Researchers will compare biomarkers and reported assessment answers at baseline and after 4 weeks with intervention.

Recent evidence has unveiled a major role of gut-brain crosstalk in the pathology of Parkinson's Disease (PD). The gastrointestinal tract is home to a diverse and complex community of microorganisms, termed the microbiota. The microbiota performs numerous functions, like digestion and metabolism of food and immune system regulation. Moreover, the microbiota produces vital molecules like neurotransmitters and metabolites that contribute to intestinal, neural, and systemic health. Dysbiosis, or an imbalanced microbiome, is common in patients with PD, and one of the major non-motor symptoms associated with PD is constipation. It is believed that an increase in pro-inflammatory bacteria and a decrease in anti-inflammatory bacteria contribute to the symptoms and pathology of PD, with recent research focusing on bacteria that produce short chain fatty acids (SCFA). SCFA are beneficial metabolites that are used as fuel by host intestinal cells, modulate inflammation, and promote overall health. Dietary fibers are the primary nutrient that is broken down by bacteria to produce SCFA. Therefore, we have formulated a prebiotic fiber blend to specifically enhance the growth and metabolism of SCFA-producing bacteria, with the aim to improve gastrointestinal health in patients with Parkinson's Disease. In this pilot clinical study, participants with PD will consume 1 fiber bar per day for 4 weeks. Questionnaires will be utilized to monitor tolerability, gastrointestinal symptoms, motor and non-motor metrics of PD. Blood and fecal samples will be collected at baseline and again after 4 weeks of consuming the fiber bar daily. The data collected during this pilot trial will be used to inform future, larger trials on the effectiveness of prebiotic fiber formulations to modulate the microbiome of PD patients, with the ultimate goal of reducing severity of PD symptoms and delaying the progression of neurodegeneration.

Inclusion Criteria:

• Diagnosis of Parkinson's Disease by a Neurologist
• Be able to give written informed consent
• Be aged between 60-75 years
• Participants are on a stable drug regimen
• Willing to consume the study product daily for the duration of the study
• Willing to abstain from pre and probiotics for 2 weeks prior to the study and throughout the 28 days of the intervention

Exclusion Criteria:

• Participants has acute or chronic gastrointestinal disease (coeliac disease, diarrhea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers) except for hiatal hernia, gastroesophageal reflux disease, haemorrhoids.
• Participants who have consumed probiotic supplements and prebiotic supplements within 2 weeks prior to Visit 1.
• Participant suffering from severe renal disease (creatinine greater than 2.5 times normal)
• Participants with markedly abnormal liver function (alt/ast greater than 2.5 times normal)
• Plan to have a major change in dietary habits during the study.
• Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results.
• Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
• Participants may not be receiving treatment involving experimental drugs/supplements. If the Participant has been in a recent experimental study, these must have been completed not less than 90 days for drugs and 30 days for supplements prior to this study.
• Consumption of non-standard diet (vegetarian, vegan, gluten free, or paleo)
• Elevated bilirubin