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

University of Ulster56 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Constipation Parkinson Disease

Interventions

Inulin, B-vitamins and vitamin DDIETARY_SUPPLEMENT

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

Placebo groupDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Human Intervention Studies Unit, Ulster University

Coleraine, County Londonderry, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 12 weeks

Secondary Outcomes

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.

Time frame: 12 weeks

Folate

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

Time frame: 12 weeks

Vitamin B6

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

Time frame: 12 weeks

Riboflavin

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

Time frame: 12 weeks

Serum total homocysteine

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

Time frame: 12 weeks

Vitamin D

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

Time frame: 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).

Time frame: 12 weeks

Data from ClinicalTrials.gov

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