Incidence of Lactose Intolerance Among Self-reported Lactose Intolerant People
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 主要终点
- Gastrointestinal Symptom VAS scores at 3 hours
研究概览
简要总结
This is a 3-sites, double-blinded, randomized, 2X2 cross-over study aiming to compare effects of milk containing only A2 type beta casein versus milk containing both A1 and A2 beta casein proteins on the gastrointestinal symptoms for the health people who self-reported to be lactose intolerant.
详细描述
Study sites: Shanghai, Guangzhou, Beijing
Eligible subjects were enrolled in the study and randomized into one of the 2 study arms:
Sequence A1-A2: Oral consumption of milk containing both A1 and A2 type beta casein at Visit 1 and milk containing only A2 type beta casein at Visit 2; Sequence A2-A1: Oral consumption of milk containing only A2 type beta casein at Visit 1 and milk containing both A1 and A2 type beta casein at Visit 2.
Washout period: 2 weeks between Visit 1 and Visit 2
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)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20~50 years old male or female subjects;
- •Non-regular milk drinker with self-reported intolerance to commercial milk;
- •Suffered from mild to moderate digestive discomfort after milk consumption;
- •Have normal electrocardiograms (ECG) and blood pressure during quiet respiration;
- •Agree not to take any medication, supplements, nutrition or other dairy products including acidophilus milk;
- •Be willing to comply with all the requirements and procedures of the study;
- •Agree to sign the informed consent form;
- •Agree not to enroll in another interventional clinical research study while participating in this study;
- •Fully understand the nature, objective, benefit and the potential risks and side effects of the study.
排除标准
- •Female on pregnant or feeding；
- •Have known dairy allergy;
- •Have severe response to milk intolerance;
- •Have history of faecal impaction;
- •Trying to lose weight by following a diet or exercise regimen designed for weight loss, or taking any drug influencing appetite and any drug for weight loss for the last three months ;
- •Have participated in similar dairy or probiotics-containing product's clinical trials within 3 months before the screening;
- •Currently taking medicines for cardiovascular or metabolic disease;
- •Have history of or be diagnosed of any of the following diseases that may affect the study results: gastrointestinal disorders, hepatopathy, nephropathy, endocrine disease, blood disorders, respiratory and cardiovascular diseases;
- •Current or previous alcohol abuser, currently taking or took illicit drugs, substance or OTC prescription drugs in regular frequency which may affect gastrointestinal disorders and study result;
- •Currently suffering from any gastrointestinal disorders or gastrointestinal disease, including but not limited to: irritable bowel syndrome, colitis, ulcerative colitis, celiac disease, irritable bowel syndrome(IBS);
- •Had hospitalizations within 3 months before screening;
- •Currently drug frequency user of that may affect the gastrointestinal function or immune system. As judged by investigator.
结局指标
主要结局
Gastrointestinal Symptom VAS scores at 3 hours
时间窗: Three hours after product intervention at each of Visit 1 and Visit 2
Gastrointestinal symptoms were self-measured by study subjects on a scale from 0 (not at all) to 9 (severe) at 3 hours after product consumption at Visit 1 and Visit 2. Data was analyzed as a repeated measures design using a mixed effects ANOVA with symptom VAS scores at 3-hour as outcome, study product (A1 or A2) and study visit (1 or 2) as fixed effects, and a random subject effect nested within the sequence of study treatment (A1-A2 or A2-A1) , and adjusted for baseline symptom scores. Type III tests of fixed effects were used for testing the effect of study products. Contrast tests were generated to compare means for each product.
次要结局
- The percentage of improvement in gastrointestinal symptoms after drinking A2 versus A1(1 hour and 3 hours after product intervention)
- Urinary galactose concentration(baseline and 3 hours after product intervention of each of Visit 1 and Visit 2)
- Gastrointestinal Symptom VAS scores at 1 hour(One hour after product intervention at each of Visit 1 and Visit 2)
- Change of urinary galactose concentration from baseline at 3 hours <0.27 mmol/L (Yes/No)(3 hours after product intervention of each of Visit 1 and Visit 2)