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

NCT06697626 | Active Not Recruiting

• 1 other identifier: REC/24/0034
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation; Parkinson Disease

Keywords

Constipation; Fibre; B-vitamins; Functional food; Nutritional status; Parkinson disease

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

Secondary Outcomes (7)

• Vitamin B12

  12 weeks

• Folate

  12 weeks

• Vitamin B6

  12 weeks

• Riboflavin

  12 weeks

• Serum total homocysteine

  12 weeks

Study Arms (2)

Dietary Supplement (Functional drink)

ACTIVE COMPARATOR

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

Placebo drink

PLACEBO COMPARATOR

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

Interventions

Inulin, B-vitamins and vitamin D DIETARY_SUPPLEMENT

Intervention twice daily with: 10g chicory inulin 100µg folic acid 5µg vitamin B12 5mg vitamin B6 2.5mg riboflavin 5µg vitamin D

Dietary Supplement (Functional drink)

Placebo group DIETARY_SUPPLEMENT

A twice daily placebo drink with similar energy content but without the additional nutrient provision

Placebo drink

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ulster: lead
• University of Leeds: collaborator
• University of Auckland, New Zealand: collaborator
• Biotechnology and Biological Sciences Research Council: collaborator

Study Sites (1)

Human Intervention Studies Unit, Ulster University

Coleraine, County Londonderry, BT52 1SA, United Kingdom

Location

MeSH Terms

Conditions

Constipation; Parkinson Disease

Interventions

Inulin; Folic Acid; Vitamin D

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 20, 2024
• Study Start: November 14, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)