The Effect of Psyllium and Wheat Bran on Body Weight in People With Parkinson's Disease and Constipation Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Body weight
研究概览
简要总结
This is a 10-week randomized, controlled study to compare the safety and efficacy of two common fiber supplements, psyllium and wheat bran in terms of changes in body weight, nutrition status, and bowel function in patients with Parkinson's Disease who have constipation symptoms. After a 2-week run-in period, participants will be randomized to receive 10 grams daily of psyllium, coarse wheat bran, or maltodextrin (placebo) for 8 weeks. Nutritional and neurological evaluations will be conducted at the beginning and end of the 8-week intervention period.
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
- Single (Participant)
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
- •Age 40-85 years
- •Drug naïve or on stable dosage of PD medications with no plans to change for the duration of the study protocol
- •Hoehn & Yahr stage < 4 in the clinical "ON" state
- •Using laxatives (Miralax, Dulcolax, sennosides, etc.) regularly over the past 1 months (≥ 2 days per week)
- •Complete informed consent in English
- •Maintain habitual diet and exercise routine throughout study period
- •Consume the study intervention twice per day during the eight-week intervention period
- •Complete daily and weekly questionnaires, and all dietary recalls over approximately 10 weeks
- •Fast (no food or drink, except plain water, coffee, or tea) at least 12 hours before each study visit
排除标准
- •Atypical or secondary Parkinsonism
- •Underweight (BMI <18.5)
- •Inability to swallow study supplement due to swallowing concerns
- •Currently using a fiber supplement
- •Use of another investigational product within 3 months of the screening visit
- •Being treated for a physician-diagnosed GI disease or condition other than constipation, gastroparesis, gastroesophageal reflux disease, or diverticular disease
研究组 & 干预措施
Coarse wheat bran
10 g per day. Participants will be instructed to divide the 10 g into 2 doses and ingest by adding the product to a food they normally eat.
干预措施: Coarse wheat bran (Dietary Supplement)
Maltodextrin
Volume equivalent to the psyllium. Participants will be instructed to divide the daily dose into 2 doses and ingest by adding the product to a food or to 8 ounces (240 mL) of a beverage that is typically consumed.
干预措施: Maltodextrin (Dietary Supplement)
Psyllium
10 g per day. Participants will be instructed to divide the 10 g into 2 doses and ingest by adding the product to at least 8 ounces (240 mL) of cold water or a beverage that is typically consumed. Participants will ingest the intervention each morning and evening for eight weeks.
干预措施: Psyllium (Dietary Supplement)
结局指标
主要结局
Body weight
时间窗: 8 weeks
The difference between in mean change (final - baseline) in body weight for psyllium, wheat bran, and placebo interventions.
次要结局
- Laxative use(Each week up to 10 weeks)
- Digestive health(Each week up to 10 weeks)
- Stool frequency(Each week up to 10 weeks)
- Constipation-related Quality of Life(8 weeks)
- Body composition(8 weeks)
- Stool consistency(Each day up to 10 weeks)
- Parkinson's Disease- related Quality of life(8 weeks)
- Nutrition risk(8 weeks)
- Appetite(Each week up to 10 weeks)
- Non-motor symptoms(8 weeks)
- Handgrip strength(8 weeks)