Incidence of Lactose Intolerance Among Self-reported Lactose Intolerant People

NCT02878876 | Completed Phase 4 DMC

• 1 other identifier: 15-SC-11-A2-004
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lactose Intolerance

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal Symptom VAS scores at 3 hours

  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.

  Three hours after product intervention at each of Visit 1 and Visit 2

Secondary Outcomes (4)

• 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

Study Arms (2)

Sequence A1-A2

EXPERIMENTAL

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

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

Sequence A2-A1

EXPERIMENTAL

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

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

Interventions

Oral consumption of milk with sequence A1-A2 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 A1-A2

Oral consumption of milk with sequence A2-A1 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).

Sequence A2-A1

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \~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.

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 (1)

• 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.

  PMID: 29070042 DERIVED

MeSH Terms

Conditions

Lactose Intolerance

Interventions

Milk

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

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Andrew J Clarke, PhD

  a2 Milk Company Ltd.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 25, 2016
• Study Start: January 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 25, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share