Efficacy of a Dietary Intervention Composed of Flaxseed, Chia, and Psyllium for the Treatment of Constipation in Institutionalized Older Adults. Medellín, 2023-2024.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 4
- 主要终点
- Adequate relief at 6 weeks
研究概览
简要总结
The objective of this clinical trial is to determine if a dietary intervention for the treatment of chronic idiopathic constipation in older adults in the city of Medellin is effective (works well), focusing on the population in geriatric care centers and institutions. The goal is to obtain scientific evidence that allows determining the efficacy of this intervention for the non-pharmacological treatment of constipation in the elderly. The main question to be answered is:
"Is a dietary product designed with psyllium, chia, and flaxseed a reliable and effective treatment for managing constipation in older adults?"
The intervention and follow-up period for the study has been set at 6 weeks (45 days). During this time, participants will receive orally, once a day (every 24 hours), 1 tablespoon (20g) of the product - FIBNUTRITION - (a natural food product rich in fiber, with its main components being flaxseed, chia, and psyllium), mixed in an 8oz glass (approximately 250ml) of room temperature water using a blender (following the manufacturer's instructions for use). The product will be provided to each patient in the morning before breakfast.
The proposed research corresponds to an intervention study, specifically a randomized, controlled, double-blind, multicenter clinical trial. The researchers will compare an intervention group (dietary intervention) with a control group (placebo: a similar product that does not contain fiber or components that can alter the intestinal tract) to observe if there is a difference of at least 40% in the prevalence of satisfactory relief of constipation symptoms (desired primary effect criterion) between the two groups.
详细描述
Population
Older adults residing in long-term care centers in the city of Medellín who meet the diagnostic criteria of Rome IV for functional or idiopathic constipation, aged over 60 years.
Sampling Design
The sample size calculation was performed using G Power 3.1.9.7 software (78). The procedure was conducted considering a 40% difference for the desired primary outcome criterion between the two groups, assuming prevalences of 10% in the control group and 50% in the intervention group, based on previous publications with similar designs to identify a minimum clinically relevant difference (35, 79, 80). With a bilateral α of 0.05 and a statistical power of 0.8, a sample size of 46 individuals was calculated, with a 20% increase to account for potential losses or dropouts, resulting in a total of 28 individuals per group, equivalent to a final sample of 56 participants.
Estimated Start and End Dates
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older adults aged 60 or older who meet the Rome IV criteria for functional constipation and reside in a long-term care facility in the city of Medellin (Annex 1).
- •Older adults who score between 0 and 2 errors on the Pfeiffer Questionnaire (SPMSQ) to detect cognitive impairment in older adults (81). Older adults with cognitive impairment may have difficulties identifying symptoms or remembering their occurrence, which is why they will be excluded from the study
排除标准
- •Older adults with known organic intestinal disease, a history of abdominal or pelvic radiation, previous intestinal surgery or severe liver or kidney disease, any previous abdominal or pelvic cancer, prostate problems, abdominal hernia, known intestinal cancer, and recent abdominal surgery. Other comorbidities that could interfere with the implementation or interpretation of the study.
- •Older adults who have used pharmacological and non-pharmacological agents including laxatives in the two weeks prior to the start of the study will be excluded from the study.
结局指标
主要结局
Adequate relief at 6 weeks
时间窗: 6 week
Proportion of older adults with satisfactory relief of general constipation symptoms after 6 weeks of intervention initiation. A binary assessment measure of "satisfactory relief" (Yes/No) corresponding to the question: "In comparison to your health before starting the treatment, do you feel that the general symptoms of constipation have improved satisfactorily during the past seven days?" is used.
次要结局
- Change from baseline in the score of the Patient Assessment of Constipation Quality of Life (PAC-QOL).(Baseline, week 6)
- Adequate relief at 3 weeks(3 week)
研究者
Santiago Gomez Velasquez
Research Professor, doctoral student in Epidemiology and Biostatistics.
CES University