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Active Not Recruiting
NCT06697626
Validation of a Novel Functional Food Designed to Meet the Nutritional Needs of People Living With Parkinson's Disease
Conditions: Constipation, Parkinson Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 37
Sponsor: University of Ulster
Location: Human Intervention Studies Unit, Ulster University Coleraine County Londonderry
Summary
Constipation is a common complication and non-motor symptom of Parkinson's disease (PD) and affects up to 80% of people with PD. It is in fact within the non-motor symptoms that nutrition and dietetic intervention could have the greatest impact. Research suggests that increasing the amount of fibre in the diet could help to alleviate the effects of constipation. Inulin is a type of fibre widely found in a variety of vegetables, and recent studies have shown that inulin can improve constipation in people with PD. With the assistance of a food company, the investigators have developed a functional drink, enriched with chicory inulin and other key nutrients, including B-vitamins and vitamin D (which are suggested within the literature to be beneficial in PD). Therefore, the investigators plan to conduct a 12-week feasibility study to test the effect of this novel functional drink on gut health outcomes, nutritional status, and overall quality of life in people living with PD.
Eligibility 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
Source: ClinicalTrials.gov (NCT06697626). StuddyBuddy aggregates publicly available trial information.