Incidence of Lactose Intolerance Among Self-reported Lactose Intolerant People

NCT ID: NCT02878876

Last Updated: 2016-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-03-31

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

Conditions

Lactose Intolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Sequence A1-A2

Dietary Supplement: Oral consumption of milk with sequence A1-A2

Group Type: EXPERIMENTAL

Oral consumption of milk with sequence A1-A2

Intervention Type: DIETARY_SUPPLEMENT

Oral consumption of 300 ml of milk containing both A1 and A2 type beta casein at 8:00 a.m. on Visit 1 (after 12-hour fasting) and 300 ml of milk containing only A2 type beta casein at 8:00 a.m. on Visit 2 (after 12-hour fasting).

Sequence A2-A1

Dietary Supplement: Oral consumption of milk with sequence A2-A1

Group Type: EXPERIMENTAL

Oral consumption of milk with sequence A2-A1

Intervention Type: DIETARY_SUPPLEMENT

Oral consumption of 300 ml of milk containing only A2 type beta casein at 8:00 a.m. on Visit 1 (after 12-hour fasting) and 300 ml of milk containing both A1 and A2 type beta casein at 8:00 a.m. on Visit 2 (after 12-hour fasting).

Interventions

Oral consumption of milk with sequence A1-A2

Oral consumption of 300 ml of milk containing both A1 and A2 type beta casein at 8:00 a.m. on Visit 1 (after 12-hour fasting) and 300 ml of milk containing only A2 type beta casein at 8:00 a.m. on Visit 2 (after 12-hour fasting).

Intervention Type: DIETARY_SUPPLEMENT

Oral consumption of milk with sequence A2-A1

Oral consumption of 300 ml of milk containing only A2 type beta casein at 8:00 a.m. on Visit 1 (after 12-hour fasting) and 300 ml of milk containing both A1 and A2 type beta casein at 8:00 a.m. on Visit 2 (after 12-hour fasting).

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

a2 Milk Company Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew J Clarke, PhD

Role: STUDY_DIRECTOR

a2 Milk Company Ltd.

References

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.

Reference Type: DERIVED

PMID: 29070042 (View on PubMed)

Other Identifiers

15-SC-11-A2-004

Identifier Type: -

Identifier Source: org_study_id