Validation of a Novel Functional Food Designed to Meet the Nutritional Needs of People Living with Parkinson's Disease (Food4PD)

Ulster University

Status: Enrolling

Conditions: Parkinson Disease; Constipation

Treatments: Dietary Supplement: Inulin, B-vitamins and vitamin D; Dietary Supplement: Placebo group

Study type: Interventional

Funder types: Other

Identifiers

NCT06697626

REC/24/0034

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

56 participants in 2 patient groups, including a placebo group

Dietary Supplement (Functional drink)

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Inulin, B-vitamins and vitamin D

Placebo drink

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo group