Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Leeds | OTHER |
| University of Auckland, New Zealand | OTHER |
| Biotechnology and Biological Sciences Research Council | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Folate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Intervention Studies Unit, Ulster University | Coleraine | County Londonderry | BT52 1SA | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003248 | Constipation |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020734 | Parkinsonian Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D007444 | Inulin |
| D005492 | Folic Acid |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
Not provided
Not provided
Twice daily intervention for 12 weeks with one of the following treatments (in powder form):
Not provided
Not provided
Not provided
| Placebo group | Dietary Supplement | A twice daily placebo drink with similar energy content but without the additional nutrient provision |
|
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 |
Serum folate and red blood cell folate measured by microbiological assay based on a chloramphenicol-resistant strain of Lactobacillus casei. |
| 12 weeks |
| Vitamin B6 | Vitamin B6 status as measured by plasma pyridoxal-5-phosphate using high-performance liquid chromatography with fluorescence detection. | 12 weeks |
| Riboflavin | Measured using the functional assay erythrocyte glutathione reductase activation coefficient, EGRac | 12 weeks |
| Serum total homocysteine | Measured by gas chromatography-tandem mass spectrometry based on methylchloroformate derivatisation. | 12 weeks |
| Vitamin D | Vitamin D as measured by serum 25-hydroxyvitamin D status, using liquid chromatography mass spectrometry. | 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). | 12 weeks |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |