Assessing the Effects of Low Lactose Milk Containing GOS (Galactooligosaccharides) on Digestive Response in Healthy Chinese Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Small bowel water content
研究概览
简要总结
We are aiming to assess the effects of low lactose milk containing galactooligosaccharides (GOS) on digestive response in healthy Chinese adults in comparison with a matching milk containing lactose.
详细描述
This is planned to be single-center, double-blind, randomized, 2x2 cross-over study.
24 healthy participants of Chinese ethnicity are planned to be enrolled. Participants will be invited to three visit days at the research site: a screening visit and two test days, 3 to 28 days apart.
During the test days, participants will be requested, after overnight fasting, to consume either the investigational product (IP), a skimmed milk powder with low lactose content and GOS, or the comparator product (CP) a matching skimmed milk powder, both reconstituted in water. Participants will then undergo a series of tests to compare the effects of these two drinks on gastrointestinal fluid retention and motility as well as on gut comfort.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Single coding
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
- •Participants declare that they are of Chinese ethnicity as well as both of their biological parents
- •Women and men aged between 18 and 60 years
- •Body mass index (BMI ≥ 18.5 & <30 kg/m2)
- •Healthy: no medical conditions or previous gastrointestinal surgery which might affect study measurements (as declared by the participant)
- •Able to understand and to sign written informed consent prior to study entry
- •Informed consent signed
- •Meets all the criteria for MRI Scan
- •Can read and speak English
排除标准
- •Medically diagnosed milk allergy
- •Subjects not willing and/or not able to comply with scheduled visits and the requirements of the study protocol
- •Diagnosed with any gastrointestinal disorders
- •History of claustrophobia
- •Pregnant (defined by pregnancy test) or breast feeding
- •History or current psychiatric illness
- •History or current neurological condition (e.g. epilepsy)
- •Consumption of > 21 alcoholic drinks in a typical week (one serving is 0.4 dl of spirits, 1 dl of wine, or 3 dl of beer as declared by participant)
- •Currently smoking (as declared by participant)
- •Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance
- •Antibiotic use within the 4 weeks preceding the intervention
- •Probiotic & prebiotics use within the 2 weeks preceding the intervention
结局指标
主要结局
Small bowel water content
时间窗: 0-315 minutes after investigational product (IP) or comparator product (CP) intake
Small bowel water content measured via MRI and calculated using the trapezoidal rule (mL\*min) at 45 minutes of interval
Gut motility
时间窗: 0-315 minutes after IP or CP intake
Maximum gut motility after product consumption (arbitrary unit) assessed via MRI performed every 45 min
次要结局
- Gastric emptying(0-315 minutes after IP or CP intake)
- Retention rate of gastric content volumes(0-315 minutes after IP or CP intake)
- Oro-caecal transit(0-315 minutes after IP or CP intake)
- H2 levels(0-315 minutes after IP or CP intake)
- Colonic volume(0-315 minutes after IP or CP intake)
- Colonic gas production via MRI(0-315 minutes after IP or CP intake)
- Colonic gas production via breath test(0-315 minutes after IP or CP intake)
- Colonic water content(0-315 minutes after IP or CP intake)
- T1 relaxation time(0-315 minutes after IP or CP intake)
- Bristol stool(3 days before and after after IP or CP intake)
- GI symptoms(0-315 minutes after IP or CP intake)