Comparison of Raw Milk Consumption vs. Other Milk Sources on Lactose Digestion in Healthy Individuals With Self-reported Lactose Intolerance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in Area Under the Curve (AUC) of Hydrogen (H2) production from day 1 at day 8
研究概览
简要总结
The purpose of this small, short pilot study is to determine the feasibility (e.g., recruitment, dose acceptance, retention) of a future longer trial comparing the effects of different types of milk (raw milk, cow's milk, nondairy-milk) on lactose maldigestion.
详细描述
The goal is to determine if raw milk consumption intake will benefit humans with lactose maldigestion, a common human response to the intake of dairy products during adult years. An increasing number of people are consuming raw unpasteurized milk. Enhanced nutritional qualities, taste, and health benefits have all been advocated as reasons for increased interest in raw milk consumption.
However, science-based data to substantiate these claims are limited or anecdotal.
Raw milk may differ in its ability to improve lactose maldigestion related symptoms from other milk types. Adult lactose maldigestion affects the majority of the world adult population. It appears that consumption of lactose containing foods by those who cannot digest lactose is a relatively common cause of irritable bowel syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, 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
- •Gender: Both women and men
- •Age: > or = 18 years
- •Ethnicity and race: All ethnic and racial backgrounds welcome
- •Elevation of breath hydrogen after ingestion of 25 g of lactose > 20 ppm over baseline
- •Planning to be available for clinic visits for the 6 weeks of study participation
- •Ability and willingness to give written informed consent
- •No known active psychiatric illness.
排除标准
- •Intake of antibiotics or other medications within the past month
- •History of diarrheal illness within past month
- •Secondary lactase deficiency
- •Self reported personal history of:
- •*gastrointestinal conditions other than related with lactose maldigestion (IBS, IRB, Short bowel, malabsorption, celiac disease, GI surgery)
- •Pregnant or Lactating
- •Inability to communicate effectively with study personnel
- •Protein allergy related to cow 's milk proteins or soybean proteins
结局指标
主要结局
Change in Area Under the Curve (AUC) of Hydrogen (H2) production from day 1 at day 8
时间窗: Day 1 and day 8 of each milk phase
Calculated as the H2 AUC above baseline at day 8 minus the H2 AUC above baseline at day 1 of each milk phase
次要结局
- Severity of symptoms of lactose intolerance for each milk phase(Day 7 of each milk phase)
研究者
Christopher Gardner
Professor of Medicine (Research)
Stanford University