High-protein Oral Supplement Improves Normalized Protein Catabolic Rate and Inflammation Markers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- IL-6
研究概览
简要总结
The investigators propose to determine the impact of high-protein beverages on protein status and inflammation markers among CKD patients undergoing hemodialysis. A 12-week double-blind randomized cross-over trial will be used in which participants (n=22) will consume a 4-ounce high protein supplement with either whey (20 g total protein) or soy (20 g total protein). Outcomes of interest include serum urea nitrogen and inflammation markers (CRP and IL-6). The findings will contribute to the knowledge gap regarding the effect of different protein types in CKD populations which can be translated to the development of affordable supplements to prevent malnutrition in adults with non-communicable diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
A third party vendor will provide the coded samples. The vendor will only reveal the actual products once the study has ended and analysis has occurred.
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
- •18 years old or older
- •diagnosed with stage 5 CKD for at least 3 months prior to the starting date of the trial
- •3 sessions of hemodialysis per week for at least three months prior to the starting date of the trial
- •All participants have the ability to provide signed informed consent
- •have not been newly diagnosed
- •not present with symptomatic infection of COVID-19
- •have no dietary restriction
- •no food allergies
- •no chewing/swallowing difficulties
排除标准
- •CKD patient stages 1-
- •CKD patient undergoing peritoneal hemodialysis.
- •In isolation due to COVID-19 or other infectious disease
- •Adult pregnant and/or lactating for the duration of the study.
- •Any other renal disease autoimmune or otherwise.
- •Use of other IP within 3 months prior of the eligibility screening.
研究组 & 干预措施
Whey protein isolate
Participants will receive 120 mls of whey protein isolate (total of 20 g protein) to consume 3x/week after dialysis treatment for 4 weeks.
干预措施: Whey protein isolate (Dietary Supplement)
Soy protein isolate
Participants will receive 120 mls of soy protein isolate (total of 20 g protein) to consume 3x/week after dialysis treatment for 4 weeks.
干预措施: Soy protein isolate (Dietary Supplement)
结局指标
主要结局
IL-6
时间窗: Up to 12 weeks of the study
Collection of serum IL-6 to identify a change from pre-post to analyze the effect protein isolates had on inflammation markers.
C-reactive protein
时间窗: Up to 12 weeks of the study
Collection of serum C-reactive protein to identify a change from pre-post to analyze the effect protein isolates had on inflammation markers.
Normalized protein catabolic rate
时间窗: Up to 12 weeks of the study
Analysis of nPCR to identify a change from pre-post to analyze the effect protein isolates had on nPCR.
次要结局
- Uremic toxins - serum p-cresol sulfate and indoxyl sulfate(Up to 12 weeks of the study)
- Malnutrition Inflammation Score(Up to 12 weeks of the study)
- Isoflavones - Serum values of Genistin and Daidzin(Up to 12 weeks of the study)
- Serum Amino acid profiles of essential and non-essential amino acids(Up to 12 weeks of the study)