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NCT Number: NCT06697626

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Intervention Studies Unit, Ulster University

Coleraine, County Londonderry, BT52 1SA, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Placebo Group

Dietary Supplement

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

Primary outcomes

  1. Dietary fibre intake

    Time frame: 12 weeks

    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.

  2. Gut microbiome profile

    Time frame: 12 weeks

    Faecal samples will be collected to examine the gut microbiome profile using faecal 16S rRNA profiling, V3-V4 region and QIIME2 pipeline.

  3. Quality of life assessment

    Time frame: 12 weeks

    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.

  4. Parkinsons Disease symptoms

    Time frame: 12 weeks

    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.

  5. Gastrointestinal symptoms

    Time frame: 12 weeks

    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.

  6. Constipation

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. Vitamin B12

    Time frame: 12 weeks

    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.

  2. Folate

    Time frame: 12 weeks

    Serum folate and red blood cell folate measured by microbiological assay based on a chloramphenicol-resistant strain of Lactobacillus casei.

  3. Vitamin B6

    Time frame: 12 weeks

    Vitamin B6 status as measured by plasma pyridoxal-5-phosphate using high-performance liquid chromatography with fluorescence detection.

  4. Riboflavin

    Time frame: 12 weeks

    Measured using the functional assay erythrocyte glutathione reductase activation coefficient, EGRac

  5. Serum total homocysteine

    Time frame: 12 weeks

    Measured by gas chromatography-tandem mass spectrometry based on methylchloroformate derivatisation.

  6. Vitamin D

    Time frame: 12 weeks

    Vitamin D as measured by serum 25-hydroxyvitamin D status, using liquid chromatography mass spectrometry.

  7. Inflammation

    Time frame: 12 weeks

    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).

Sponsors and collaborators

Lead sponsor

University of Ulster

Other

Collaborators

  • Biotechnology and Biological Sciences Research Council
  • University of Auckland, New Zealand
  • University of Leeds

Registry information

Official study title

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

Acronym: Food4PD

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2024
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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