Clinical trial NCT02878876: Incidence of Lactose Intolerance Among Self-reported Lactose Intolerant People
Official title: Incidence of Lactose Intolerance Among Self-reported Lactose Intolerant People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lactose Intolerance
Lead sponsor: a2 Milk Company Ltd.
Sponsor class: INDUSTRY
First posted: 2016-08-25
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Gastrointestinal Symptom VAS scores at 3 hours
timeFrame: Three hours after product intervention at each of Visit 1 and Visit 2
Secondary outcomes:
measure: The percentage of improvement in gastrointestinal symptoms after drinking A2 versus A1
timeFrame: 1 hour and 3 hours after product intervention
measure: Urinary galactose concentration
timeFrame: baseline and 3 hours after product intervention of each of Visit 1 and Visit 2
measure: Gastrointestinal Symptom VAS scores at 1 hour
timeFrame: One hour after product intervention at each of Visit 1 and Visit 2
measure: Change of urinary galactose concentration from baseline at 3 hours <0.27 mmol/L (Yes/No)
timeFrame: 3 hours after product intervention of each of Visit 1 and Visit 2
Other outcomes:
Locations:
Study officials:
affiliation: a2 Milk Company Ltd.
name: Andrew J Clarke, PhD
role: STUDY_DIRECTOR
References:
citation: He M, Sun J, Jiang ZQ, Yang YX. Effects of cow's milk beta-casein variants on symptoms of milk intolerance in Chinese adults: a multicentre, randomised controlled study. Nutr J. 2017 Oct 25;16(1):72. doi: 10.1186/s12937-017-0275-0.