NCT04829760已完成不适用
The Effect of Psyllium and Wheat Bran on Body Weight in People With Parkinson's Disease and Constipation Symptoms
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 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
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
- Digestive health(Each week up to 10 weeks)
- Stool frequency(Each week up to 10 weeks)
- Laxative use(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)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Comparison of Psyllium and Microcrystalline Cellulose on Glycemic Measures in Subjects With Impaired Fasting GlucoseImpaired Fasting GlucoseNCT01549600Procter and Gamble18
已完成
不适用
Fiber Regimens for Constipation SymptomsConstipationNCT03845673University of Texas Southwestern Medical Center53
已完成
不适用
Evaluation of the Efficacy of Two Dietary Supplements Claiming Anti-aging PropertiesHealthy VolunteersNCT06048354Seppic72
已完成
不适用
A Study to Assess the Effect of Psyllium vs. Wheat Dextrin on Glycemic Control and Inflammatory Markets in Diabetes Mellitus 2Type2 DiabetesNCT04547790Mayo Clinic101
Unknown
不适用
Study to Investigate the Effect of Dietary Fibre Supplementation on Long-term Glucose Control in Prediabetic SubjectsDietary HabitsNCT05157815Tate & Lyle46