Pilot Study: Tolerability of Feeding Different Doses of Bovine Milk Oligosaccharides for Modifying Gastrointestinal Function in Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Gut microbiota
研究概览
简要总结
The purpose of this study is to elucidate tolerability and effectiveness in consumption of the complex indigestible sugars from dairy products called bovine milk oligosaccharides (BMO) to enrich intestinal microflora toward beneficial populations.
详细描述
This is a single-blind crossover study designed to determine if BMO at two different doses selectively enrich beneficial bacteria in the human gut and will be tolerated in healthy participants compared with a placebo control supplement. Each participant will consume two sachets of supplement for eleven days, separated by a two-week washout before starting the second and third arms. To determine the effect of dose, the placebo-control supplement will be administered in the first arm, followed by the low and high dose. Participants will collect stool and first morning urine and study personnel collected blood from each participant at baseline (day 0) and at the end (Day 11) of each study arm for all three arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women aged 18-40 years old
- •BMI 18-25
- •Born by vaginal birth (not C-section)
- •Breastfed for a minimum of 2 months after birth
排除标准
- •Individuals who regularly consume high fiber cereals or fiber supplements
- •Individuals who frequently consume yogurt (eligible if willing to refrain consumption during the study period)
- •Individuals who are lactose intolerant and/or allergic to dairy or wheat
- •Individuals who use tobacco products
- •Individuals who are pregnant or lactating
- •Individuals with a known presence of gastrointestinal/malabsorption disorders or autoimmune disease
- •Individuals taking prescription or over-the-counter medications that include pre/probiotics, corticosteroids, anti-obesity agents, laxatives, and lipid- altering medications
结局指标
主要结局
Gut microbiota
时间窗: Change from baseline to day 11
Gut microbiota will be analyzed for 16s rRNA by next generation sequencing, terminal restriction fragment length polymorphism, and quantitative polymerase chain reaction.
次要结局
- Urinary Metabolites(Days 0, 4, 11)
- Stool Consistency(Minus Day 7 and Days 0-10)
- Fecal BMO(Days 0, 4 and 11)
- Fecal Metatranscriptome(Days 0 and 11)
- Plasma Lipid Profile(Day 0 and Day 11)
- Plasma Glucose(Day 0 and Day 11)
- Dietary Macronutrient Intake(Day 0)
- Gut Tolerability(Days Minus 7 and Days 0-10)