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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Parkinson Disease; Constipation
• Intervention / Treatment: Dietary supplement: Inulin, B-vitamins and vitamin D; Dietary supplement: Placebo group

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • County Londonderry
    • Coleraine, County Londonderry, United Kingdom, BT52 1SA
      • Human Intervention Studies Unit, Ulster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Dietary supplement: Inulin, B-vitamins and vitamin D; Intervention twice daily with: 10g chicory inulin 100µg folic acid 5µg vitamin B12 5mg vitamin B6 2.5mg riboflavin 5µg vitamin D
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.	Dietary supplement: Placebo group; A twice daily placebo drink with similar energy content but without the additional nutrient provision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary fibre intake	A food frequency questionnaire and 4-day food diary will be completed and analysed using nutritional analysis software to determine intake of dietary fibre (g/day) pre- and post- intervention.	12 weeks
Gut microbiome profile	Faecal samples will be collected to examine the gut microbiome profile using faecal 16S rRNA profiling, V3-V4 region and QIIME2 pipeline.	12 weeks
Parkinsons Disease symptoms	Assessed using the MDS-Unified Parkinson Disease Rating Scale (MDS-UDPRS). The MDS-UPDRS has four parts: I: Non-motor Experiences of Daily Living; II: Motor Experiences of Daily Living; III: Motor Examination; IV: Motor Complications. Each question is anchored with five responses that are linked to commonly accepted clinical terms: 0=normal, 1=slight, 2=mild, 3=moderate, and 4=severe. Higher scores indicate more severe impairment.	12 weeks
Gastrointestinal symptoms	Assessed using the Gastrointestinal Symptom Rating Scale. This 15-item questionnaire uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative option. Higher scores indicate more severe symptoms.	12 weeks
Constipation	Assessed using the Bristol Stool Chart, a diagnostic tool that participants can use to classify their stools based on their appearance. The chart ranges from type 1 (hard) to type 7 (loose, watery) and may identify problems with bowel movements through the shape and consistency of the stool.	12 weeks
Quality of life assessment	Assessed using The Parkinson's Disease Questionnaire (PDQ-39). This 39-item questionnaire assesses how often participants with Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication. Answers are based on a 5-point ordinal scoring system ranging from 0 to 4, with lower scores reflecting a better quality of life.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitamin B12	Serum total vitamin B12 measured by microbiological assay based on a colistin sulphate-resistant strain of Lactobacillus leichmannii; serum methylmalonic acid measured by gas chromatography-tandem mass spectrometry based on methylchloroformate derivatisation.	12 weeks
Folate	Serum folate and red blood cell folate measured by microbiological assay based on a chloramphenicol-resistant strain of Lactobacillus casei.	12 weeks
Vitamin B6	Vitamin B6 status as measured by plasma pyridoxal-5-phosphate using high-performance liquid chromatography with fluorescence detection.	12 weeks
Riboflavin	Measured using the functional assay erythrocyte glutathione reductase activation coefficient, EGRac	12 weeks
Serum total homocysteine	Measured by gas chromatography-tandem mass spectrometry based on methylchloroformate derivatisation.	12 weeks
Vitamin D	Vitamin D as measured by serum 25-hydroxyvitamin D status, using liquid chromatography mass spectrometry.	12 weeks
Inflammation	Markers of inflammation (analysed by enzyme-linked immunosorbent assay): C-reactive protein (CRP), interleukin 6 (IL-6), interleukin 10 (IL-10), tumour necrosis factor (TNF-α).	12 weeks

Collaborators and Investigators

• Sponsor: University of Ulster
• Collaborators: University of Leeds; Biotechnology and Biological Sciences Research Council; University of Auckland, New Zealand

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 15, 2024
• First Submitted That Met QC Criteria: November 19, 2024
• First Posted (Actual): November 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Constipation; Nutritional status; Parkinson disease; Functional food; B-vitamins; Fibre
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Digestive; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Parkinson Disease; Constipation; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dietary Carbohydrates; Carbohydrates; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Polymers; Macromolecular Substances; Pterins; Pteridines; Polysaccharides; Starch; Glucans; Biopolymers; Fructans; Secosteroids; Vitamin D; Folic Acid; Inulin
• Other Study ID Numbers: REC/24/0034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No