A new functional drink to help with constipation in people with Parkinson's disease
Food4PD: Validation of a Novel Functional Food Designed to Meet the Nutritional Needs of People Living with Parkinson's
This study is testing a new drink made to help people with Parkinson's disease manage constipation and improve their gut health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Ulster Academic / other |
| Locations | 1 site (Coleraine, County Londonderry) |
| Trial ID | NCT06697626 on ClinicalTrials.gov |
What this trial studies
This study aims to validate a novel functional drink designed to meet the nutritional needs of individuals living with Parkinson's disease, particularly focusing on alleviating constipation, a common non-motor symptom. The drink is enriched with chicory inulin, B-vitamins, and vitamin D, which are believed to improve gut health and overall quality of life. Over a 12-week period, participants will be monitored for changes in their nutritional status and gut health outcomes compared to a placebo group. The study will include adults diagnosed with Parkinson's disease who can provide informed consent.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with Parkinson's disease who are experiencing constipation.
Not a fit: Patients living in institutional care, those with diabetes, or individuals currently taking antibiotics or certain supplements may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve gut health and quality of life for patients with Parkinson's disease suffering from constipation.
How similar studies have performed: Previous studies have indicated that dietary interventions, particularly those involving inulin, can improve constipation in individuals with Parkinson's disease, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Parkinson Disease (PD) * Aged ≥18 years * Individuals with the capacity to provide informed consent Exclusion Criteria: * Individuals with PD living in institutional care or in hospital * Drug, infection or toxin induced parkinsonism * Individuals with diabetes * B12 injection users * Currently taking antibiotics * Using supplements containing the nutrients of interest (B-vitamins, inulin, probiotics) * Any other medical, cognitive or psychosocial issue, or co-enrolment in another study, that could interfere or disrupt adherence to the study requirements * An allergy to any of the ingredients in the functional and/or control drinks * Consuming a fermented food and/or probiotic yogurts on a daily basis
Where this trial is running
Coleraine, County Londonderry
- Human Intervention Studies Unit, Ulster University — Coleraine, County Londonderry, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.