Effects Comparison of A1 and A2 Milk on Gastrointestinal Physiology, Symptoms and Cognitive Behavior

NCT02406469 | Completed Phase 4

• 1 other identifier: 14-SC-07-A2-01
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-site, double-blinded, randomized, controlled, 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 physiology, symptoms and cognitive behaviour for the health people who are intolerant to traditional cow's milk.

Conditions

Lactose Intolerance

Outcome Measures

Primary Outcomes (1)

• Serum levels of immune response markers in correlation to symptoms of intolerance

  Serum levels of interlukin-4, IgE, IgG1 and IgG2A

  Baseline 1 (Day 0), end of intervention phase 1 (Day 14), baseline 2 (Day 28), end of intervention phase 2 (Day 42)

Secondary Outcomes (6)

• Regional gut transit time

  End of intervention phase 1 (Day 14), end of intervention phase 2 (Day 42)

• Fecal short chain fatty acid measurements

  Baseline 1 (Day 0), end of intervention phase 1 (Day 14), baseline 2 (Day 28), end of intervention phase 2 (Day 42)

• Gastrointestinal symptoms (VAS score)

  Daily from Day 0 to Day 42

• Stool frequency

  Daily from Day 0 to Day 42

• Stool consistency (Bristol Score)

  Daily from Day 0 to Day 42

Study Arms (2)

Sequence A1-A2

EXPERIMENTAL

Oral consumption of milk containing both A1 and A2 type beta casein in intervention phase 1 and milk containing only A2 type beta casein in intervention phase 2.

Dietary Supplement: Oral consumption milk Tetra Pak

Sequence A2-A1

PLACEBO COMPARATOR

Oral consumption of milk containing only A2 type beta casein in intervention phase 1 and milk containing both A1 and A2 type beta casein in intervention phase 2.

Dietary Supplement: Oral consumption milk Tetra Pak

Interventions

Oral consumption milk Tetra Pak DIETARY_SUPPLEMENT

Oral consumption of assigned products in the form of Tetra Pak (A1 or A2 milk according to randomization), 250 ml/time, 2 times daily after meal, for a total of 28 days (14 days in each intervention phase).

Sequence A1-A2; Sequence A2-A1

Eligibility Criteria

• Age: 25 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~3568 years old male or female subjects who:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• a2 Milk Company Ltd.: lead

Related Publications (2)

• Deth R, Clarke A, Ni J, Trivedi M. Clinical evaluation of glutathione concentrations after consumption of milk containing different subtypes of beta-casein: results from a randomized, cross-over clinical trial. Nutr J. 2016 Sep 29;15(1):82. doi: 10.1186/s12937-016-0201-x.

  PMID: 27680716 DERIVED

• Jianqin S, Leiming X, Lu X, Yelland GW, Ni J, Clarke AJ. Effects of milk containing only A2 beta casein versus milk containing both A1 and A2 beta casein proteins on gastrointestinal physiology, symptoms of discomfort, and cognitive behavior of people with self-reported intolerance to traditional cows' milk. Nutr J. 2016 Apr 2;15:35. doi: 10.1186/s12937-016-0147-z.

  PMID: 27039383 DERIVED

MeSH Terms

Conditions

Lactose Intolerance

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Andrew J Clarke, PhD

  a2 Milk Company Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: April 2, 2015
• Study Start: October 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: April 2, 2015

Record last verified: 2015-03