Clinical trial NCT06697626: Validation of a Novel Functional Food Designed to Meet the Nutritional Needs of People Living with Parkinson's Disease
Official title: Food4PD: Validation of a Novel Functional Food Designed to Meet the Nutritional Needs of People Living with Parkinson's
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Constipation
Parkinson Disease
Keywords: Constipation
Fibre
B-vitamins
Functional food
Nutritional status
Parkinson disease
Lead sponsor: University of Ulster
Sponsor class: OTHER
Collaborators: name: University of Leeds
name: University of Auckland, New Zealand
name: Biotechnology and Biological Sciences Research Council
First posted: 2024-11-20
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Twice daily intervention for 12 weeks with one of the following treatments (in powder form):

1. An enriched functional drink containing chicory inulin (10g), folic acid (100µg), vitamin B12 (5µg), vitamin B6 (5mg), riboflavin (2.5mg) and vitamin D (5µg).
2. A control/placebo drink with similar energy content but without the additional nutrient provision.
Primary purpose: PREVENTION

Brief 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

Primary outcomes:
measure: Dietary fibre intake
timeFrame: 12 weeks
measure: Gut microbiome profile
timeFrame: 12 weeks
measure: Quality of life
timeFrame: 12 weeks
measure: Parkinsons Disease symptoms
timeFrame: 12 weeks
measure: Gastrointestinal symptoms
timeFrame: 12 weeks
measure: Constipation
timeFrame: 12 weeks
Secondary outcomes:
measure: Vitamin B12
timeFrame: 12 weeks
measure: Folate
timeFrame: 12 weeks
measure: Vitamin B6
timeFrame: 12 weeks
measure: Riboflavin
timeFrame: 12 weeks
measure: Serum total homocysteine
timeFrame: 12 weeks
measure: Vitamin D
timeFrame: 12 weeks
measure: Inflammation
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Coleraine
country: United Kingdom
facility: Human Intervention Studies Unit, Ulster University
state: County Londonderry
Study officials:
References: