Food4PD: Validation of a Novel Functional Food Designed to Meet the Nutritional Needs of People Living With Parkinson's

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of Parkinson Disease (PD)

• Aged ≥18 years

• Individuals with the capacity to provide informed consent

Locations
Other Locations
United Kingdom
Human Intervention Studies Unit, Ulster University
RECRUITING
Coleraine
Time Frame
Start Date: 2024-11-14
Estimated Completion Date: 2026-03
Participants
Target number of participants: 56
Treatments
Active_comparator: Dietary Supplement (Functional drink)
An enriched functional drink containing chicory inulin (10g), folic acid (100µg), vitamin B12 (5µg), vitamin B6 (5mg), riboflavin (2.5mg) and vitamin D (5µg).~This drink will be consumed twice daily for an intervention period of 12 weeks
Placebo_comparator: Placebo drink
A placebo drink drink with similar energy content but without the additional nutrient provision.~This drink will be consumed twice daily an intervention period of 12 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: University of Leeds, Biotechnology and Biological Sciences Research Council, University of Auckland, New Zealand
Leads: University of Ulster

This content was sourced from clinicaltrials.gov