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NCT06697626Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 1 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
37 (actual)
First submitted
15 Nov 2024
Start date
14 Nov 2024
Primary completion date
17 Apr 2026
Lead sponsor
University of Ulster
NCT number
NCT06697626

What you commit to

  • Study type: Interventional
  • Participants enrolled: 37
  • From 14 Nov 2024 to the primary completion date, 17 Apr 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Currently taking antibiotics

Other illness

  • Drug, infection or toxin induced parkinsonism
  • Individuals with diabetes
  • An allergy to any of the ingredients in the functional and/or control drinks

Other

  • Individuals with PD living in institutional care or in hospital
  • B12 injection users
  • 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
  • Consuming a fermented food and/or probiotic yogurts on a daily basis

Who the study is looking for

  • Diagnosis of Parkinson Disease (PD)
  • Aged ≥18 years
  • Individuals with the capacity to provide informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Human Intervention Studies Unit, Ulster University
Coordinator of this site? Confirm its status
ColeraineUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.