A Novel Partial-enteral Nutrition Protocol to Improve Nutrition Status of Adults Patients Experiencing a Crohn's Disease Flare and Starting New Immunologic Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Nutrient intake
研究概览
简要总结
A novel dietary intervention combining a standardized IBD diet (IBD-AID) with supplementation from a pea protein plant-based oral nutrition supplement (ONS) (Kate Farms Peptide 1.5) to improve protein, calorie, and nutrient intake in adult patients experiencing a Crohn's disease flare starting new immunologic therapy. Additionally, this study will include objective measures of body composition to improve nutrition status assessment and provide a more sensitive measure of intervention efficacy compared to anthropometric measures of body weight or BMI.
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
- None
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
- •Moderate to severe CD as defined by physician and starting new biologic therapy
- •Able and willing to complete the study procedures
- •Age > 18
- •Able to comply with study measures in the opinion of the investigator
排除标准
- •Diagnosis of short bowel syndrome
- •Presence of ileostomy or colostomy
- •Presence of a pacemaker or any electronic implantable device
- •Use of pre or probiotic supplements within 14 days of randomization
- •High risk for development of refeeding syndrome
- •In the opinion of the investigator would not complete the study procedures
- •Patients with active implanted medical devices, e.g. cardiac pacemakers, defibrillators or patients connected to electronic life support devices
- •Pregnant Patients: while the use of bioimpedance technology in pregnant patients has been shown to have no adverse effects, it has yet to be clinically validated for use with that population group
- •Serious, concomitant illness that, in the opinion of the investigator would interfere with evaluation of safety or efficacy, or put the participant at risk of harm from study participation
研究组 & 干预措施
IBD-AID diet
干预措施: IBD-AID diet (Other)
IBD-AID Diet + Kate Farms Peptide 1.5
干预措施: IBD-AID diet combined with Kate Farms Peptide 1.5 (Dietary Supplement)
结局指标
主要结局
Nutrient intake
时间窗: 8 weeks
Nutrient intake improvement assessed by 24-hour dietary recall from a combined intervention of a standard IBD-AID diet with an oral nutrition supplement drink (Kate Farms Peptide 1.5) compared to a standard diet alone without an oral nutrition supplement drink.
次要结局
- Body composition(8 weeks)