Validation of a Novel Functional Food Designed to Meet the Nutritional Needs of People Living with Parkinson's Disease
- Conditions
- ConstipationParkinson Disease
- Registration Number
- NCT06697626
- Lead Sponsor
- University of Ulster
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 56
- Diagnosis of Parkinson Disease (PD)
- Aged ≥18 years
- Individuals with the capacity to provide informed consent
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Dietary fibre intake 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.
Gut microbiome profile 12 weeks Faecal samples will be collected to examine the gut microbiome profile using faecal 16S rRNA profiling, V3-V4 region and QIIME2 pipeline.
Quality of life 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.
Parkinsons Disease symptoms 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.
Gastrointestinal symptoms 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.
Constipation 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 Outcome Measures
Name Time Method Vitamin B12 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.
Folate 12 weeks Serum folate and red blood cell folate measured by microbiological assay based on a chloramphenicol-resistant strain of Lactobacillus casei.
Vitamin B6 12 weeks Vitamin B6 status as measured by plasma pyridoxal-5-phosphate using high-performance liquid chromatography with fluorescence detection.
Riboflavin 12 weeks Measured using the functional assay erythrocyte glutathione reductase activation coefficient, EGRac
Serum total homocysteine 12 weeks Measured by gas chromatography-tandem mass spectrometry based on methylchloroformate derivatisation.
Vitamin D 12 weeks Vitamin D as measured by serum 25-hydroxyvitamin D status, using liquid chromatography mass spectrometry.
Inflammation 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).
Trial Locations
- Locations (1)
Human Intervention Studies Unit, Ulster University
🇬🇧Coleraine, County Londonderry, United Kingdom