Casein Glycomacropeptide in Healthy Subjects - Anti-inflammatory and Microbiome Modulating Effects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Number of participants with changes in systemic inflammation markers and cellular immune response
研究概览
简要总结
Casein glycomacropeptide (CGMP) has anti-inflammatory properties in experimental rodent colitis and using human in vitro inflammation models. Its use as a food ingredient has proven safe and with no influence on dietary intake. In a pilot study the investigators found, that orally administered CGMP seems to have a beneficial effect comparable to that of mesalazine in active distal ulcerative colitis.
The investigators now wish to evaluate the effects in healthy subjects by studying the anti-inflammatory and microbiome modulating properties and by assessing possible changes in gastrointestinal symptoms.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caucasians
- •Body Mass Index 18.5-25.0
排除标准
- •Within 3 months: Acute intestinal disease (diarrhea more than 3 days in a week or bloody stools), hospital admission or antibiotic treatment.
- •Chronic inflammatory disease or intestinal disease, including Crohn's disease, ulcerative colitis, celiac disease, rheumatoid arthritis or any other autoimmune joint disease, multiple sclerosis or any intestinal surgery apart from appendectomy.
- •Pregnant or nursing.
- •Unable to speak and understand Danish.
研究组 & 干预措施
Casein glycomacropeptide (CGMP)
During 4 weeks a daily oral intake of CGMP-protein-shake.
干预措施: Casein glycomacropeptide (Dietary Supplement)
Placebo
During 4 weeks a daily oral intake of placebo-shake consisting of milk powder.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Number of participants with changes in systemic inflammation markers and cellular immune response
时间窗: 4 weeks
C-reactive protein, leukocyte count
次要结局
- Number of participants with changes in the intestinal microbiome(4 weeks)
- Number of participants with changes in gastrointestinal symptoms(4 weeks)