A Randomized, Crossover Clinical Study Evaluating the Digestibility of Serum-Derived Bovine Immunoglobulin Protein Isolate (SBI) in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Concentration of Total Plasma Amino Acids
研究概览
简要总结
The purpose of this study is to determine the digestibility of serum-derived bovine immunoglobulin protein isolate in healthy adults. The information generated may help elucidate SBI's mechanism of action.
详细描述
This study is evaluating the safety and absorption of serum-derived bovine immunoglobulin protein isolate (SBI) in healthy adults using 5, 10, and 20 g doses of SBI and placebo equivalents in a double blind crossover study and SBI affects over 14 days. Additionally, plasma amino acid response and IgG concentrations in both stool and plasma will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index of 18-32
- •Medically normal with no significant abnormal findings at screening
排除标准
- •Allergy or intolerance to beef
- •Participated in another investigational study within 30 days
- •Seropostive for HIV, hepatitis B surface antigen, hepatitis C virus
研究组 & 干预措施
Matching Placebo
Placebo will be taken either on Day 1 or on Day 2 based on the randomization during the double-blind, crossover phase.
干预措施: Matching Placebo (Other)
5g Serum-derived bovine immunoglobulin protein isolate (SBI)
Phase 1: Twelve subjects will receive either a 5.0 g total daily dose of SBI on Day 1 followed by 5.0 g Placebo on Day 2 or a 5.0 g total daily dose of Placebo on Day 1 followed by 5.0 g SBI on Day 2 during the double-blind, crossover phase.
Phase 2: 2.5g SBI will be taken two times a day for 14 days during the open-label phase.
干预措施: Serum-derived bovine immunoglobulin protein isolate (SBI) (Other)
10g Serum-derived bovine immunoglobulin protein isolate (SBI)
Phase 1: Twelve subjects will receive either a 10.0 g total daily dose of SBI on Day 1 followed by 10.0 g Placebo on Day 2 or a 10.0 g total daily dose of Placebo on Day 1 followed by 10.0 g SBI on Day 2 during the double-blind, crossover phase.
Phase 2: 5.0 g SBI will taken two times a day for 14 days during the open-label phase.
干预措施: Serum-derived bovine immunoglobulin protein isolate (SBI) (Other)
20g Serum-derived bovine immunoglobulin protein isolate (SBI)
Phase 1: Twelve subjects will receive either a 20.0 g total daily dose of SBI on Day 1 followed by 20.0 g Placebo on Day 2 or a 20.0 g total daily dose of Placebo on Day 1 followed by 20.0 g SBI on Day 2 during the double-blind, crossover phase.
Phase 2: 20.0 g SBI will be taken two times a day for 14 days during the open-label phase.
干预措施: Serum-derived bovine immunoglobulin protein isolate (SBI) (Other)
结局指标
主要结局
Concentration of Total Plasma Amino Acids
时间窗: 0, 180 minutes following administration of the investigational product in crossover phase.
Plasma amino acid concentrations (umol/mL) were measured after administration of SBI or Placebo during the Cross-over phase.
次要结局
- Number of Participants With Quantifiable Bovine IgG Plasma Concentration(0 and 90 minutes following investigational product dosing during crossover phase; and after 14 days of open label dosing)
- Bovine IgG Concentration in Stool(14 days after starting the open label phase)