Mediterranean Diet Intervention to Improve Gastrointestinal Function in Parkinson's Disease: a Randomized, Controlled, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- GSRS Constipation Syndrome Score
研究概览
简要总结
This is a 10-week randomized, controlled study to investigate the effect of a Mediterranean diet intervention on gastrointestinal function in Parkinson's disease. After a 2-week run-in period, participants will be instructed to receive standard of care for constipation or receive standard of care + follow a Mediterranean diet for 8 weeks and answer daily and weekly questionnaires. Nutritional and neurological evaluations and stool samples will be collected at 0, 4 and 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician-diagnosed Parkinson's disease aged 40-85 years
- •Drug naïve or on stable dosage of Parkinson's medications with no plans to change for the duration of the study protocol
- •Hoehn & Yahr stage =<2.5 in the clinical "ON" state
- •Constipation syndrome scores >=2.0 based on the GSRS
- •Consume <20 grams of fiber daily based on the Block Fruit/Vegetable/Fiber screener
- •Able to complete informed consent in English
- •Willing to maintain habitual diet through the pre-baseline period.
- •Willing to make dietary changes to follow a Mediterranean diet and/or receive standard of care for constipation during the intervention period.
- •Willing to complete daily and weekly questionnaires and 12 dietary recalls over approximately 10 weeks.
- •Able to provide stool samples during the study collection periods.
- •Willing to avoid strenuous exercise and alcohol such as beer, wine, and cocktails 24 hours prior to each of the 3 study visits.
- •Able to fast (no food or drink, except water, or decaf tea) at least 12 hours before each study visit
- •Willing to discontinue taking prebiotic, herbal, or high-dose vitamin or mineral supplements that may impact inflammation during the pre-baseline period and throughout the study protocol.
排除标准
- •Atypical or secondary Parkinsonism
- •Underweight (BMI <18.5)
- •History of deep brain stimulation (DBS) surgery
- •Regular use of enemas or suppositories to alleviate constipation (e.g., >1 time per week)
- •Use of another investigational product within 3 months of the screening visit
- •Antibiotic or probiotic supplement use within 2 months from the day of stool collection
- •Currently being treated for a physician-diagnosed GI disease or condition other than constipation, irritable bowel disease, gastroparesis, reflux or diverticular disease
研究组 & 干预措施
Standard of Care + Mediterranean Diet
Participants will be given standard of care for constipation (handout) plus individualized diet education on the Mediterranean diet and instructed to follow the diet during the 8-week intervention period. Diet education will be administered by a study dietitian and followed with weekly phone calls to ensure compliance, improve adherence to the diet and monitor for adverse events.
干预措施: Standard of care + Mediterranean diet (intervention) (Other)
Standard of Care
Participants will be given standard of care for constipation (handout) to utilize during the 8-week intervention period. A study dietitian will follow up with weekly phone calls to support adherence and monitor for adverse events.
干预措施: Standard of care (control) (Other)
结局指标
主要结局
GSRS Constipation Syndrome Score
时间窗: 10 weeks
The difference between mean change (final - baseline) in constipation syndrome scores for the Med diet versus control diet.
次要结局
- Stool Frequency(Each week up to 10 weeks)
- Stool Form(Each day up to 10 weeks)
- Quality of Life Related to Digestive Health(Every week up to 10 weeks)
- Digestive Health(Every week up to 10 weeks)
- Fecal Microbial Diversity(Baseline (Week 0); Midpoint (Week 4); Final (Week 8))
- Laxative Usage(Each week up to 10 weeks)
- Fecal Microbial Quantitative Polymerase Chain Reaction (qPCR)(Baseline (Week 0); Midpoint (Week 4); Final (Week 8))
- Intestinal Inflammation and Permeability(Baseline (Week 0); Midpoint (Week 4); Final (Week 8))