Constipation, Parkinson Disease
Conditions
Keywords
Constipation, Fibre, B-vitamins, Functional food, Nutritional status, Parkinson disease
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.
Interventions
DIETARY_SUPPLEMENTInulin, 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
DIETARY_SUPPLEMENTPlacebo group
A twice daily placebo drink with similar energy content but without the additional nutrient provision
Sponsors
University of Ulster
University of Leeds
University of Auckland, New Zealand
Biotechnology and Biological Sciences Research Council
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 assessment | 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United Kingdom
Outcome results
None listed