Comparison of Meal Replacements Versus Protein Supplements and Utilizing the PDCAAS Method in the Bariatric Patient
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Protein Absorption
研究概览
简要总结
The purpose of this research study is to compare the varying qualities of protein supplements utilizing the Protein Digestibility Corrected Amino Acid Score (PDCAAS) method and evaluating the clinical outcome related to protein stores and absorption.
详细描述
The PDCAAS has been adopted by the Food and Agricultural Organization (FAO) of the World Health Organization (WHO) and is currently recognized as the standard method to evaluate protein quality. This study will also examine patient tolerability, satiety, and satisfaction while using meal replacements versus protein supplements. This research study looks to gain knowledge on the varying qualities of protein and find the most effective protein supplement and/or meal replacement that provides increased patient compliance and promotes a healthy recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Persons that are scheduled to undergo the adjustable gastric banding (AGB) surgery utilizing the AP Lap-Band System.
- •Not having any medical confounding factors as described in
排除标准
- •Willing to comply with food and exercise logs and comply with the full-liquid diet, both pre-and-post-operatively.
- •Exclusion Criteria:
- •Persons who are not undergoing AGB surgery or are unwilling to comply with study methods or are medically not eligible.
- •Taking diuretics
- •Have been diagnosed with unstable diabetes, unstable neurologic conditions, unstable cardiac conditions or gastro-intestinal disorders, renal dysfunction, wounds, and autoimmune disorders that may increase protein needs.
- •Uncontrolled gastrointestinal disease, such as Crohn's disease, diverticulitis, Celiac disease, or ulcerative colitis.
- •Active malignancy
- •Patients will also be excluded if pre-operative vitamin deficiencies are not corrected by surgery.
结局指标
主要结局
Protein Absorption
时间窗: 4 weeks
protein stores and protein absorption per lab results collected at required visits
次要结局
- Patient Compliance with Protein Supplement(4 weeks)
- Patient tolerability and satisfaction of protein supplement(4 weeks)