Food4PD: Validation of a Novel Functional Food Designed to Meet the Nutritional Needs of People Living With Parkinson's
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Dietary fibre intake
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson Disease (PD)
- •Aged ≥18 years
- •Individuals with the capacity to provide informed consent
排除标准
- •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
研究组 & 干预措施
Dietary Supplement (Functional drink)
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
干预措施: Inulin, B-vitamins and vitamin D (Dietary Supplement)
Placebo drink
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.
干预措施: Placebo group (Dietary Supplement)
结局指标
主要结局
Dietary fibre intake
时间窗: 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
时间窗: 12 weeks
Faecal samples will be collected to examine the gut microbiome profile using faecal 16S rRNA profiling, V3-V4 region and QIIME2 pipeline.
Parkinsons Disease symptoms
时间窗: 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
时间窗: 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
时间窗: 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.
Dietary fibre intake
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Riboflavin(12 weeks)
- Serum total homocysteine(12 weeks)
- Vitamin D(12 weeks)
- Vitamin B12(12 weeks)
- Folate(12 weeks)
- Vitamin B6(12 weeks)
- Inflammation(12 weeks)