RecruitingACTRN12625000285459

The A1 Protein Free Vs Conventional milk study in lactose tolerant and lactose intolerant consumers

A randomised, controlled, double-blind, crossover pilot study investigating the metabolism of lactose following consumption of A1 and A2 beta casein milk proteins in lactose tolerant and lactose intolerant consumers


Sponsor

The a2 Milk Company

Enrollment

50 participants

Start Date

Jul 11, 2025

Study Type

Interventional

Conditions

Summary

Conventional milk generally contains A1-type beta casein proteins which have been found to cause symptoms of lactose intolerance in some people. We want to see if symptoms of lactose intolerance are less when people drink A1 protein free milk, when compared to drinking conventional milk containing A1 protein. We also want to confirm this with physiological markers in blood, urine, and faeces, and measure them over time.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

Some people feel unwell after drinking regular cow's milk — experiencing symptoms like bloating, gas, and stomach cramps. While this is often blamed on lactose, some research suggests that a protein in standard milk called A1 beta-casein may also play a role. This study compares A1 protein-free milk (which lacks the A1 protein) with conventional milk to see if there is a difference in digestive comfort. Participants — both people who are lactose tolerant and those who are lactose intolerant — will drink each type of milk in separate test sessions, and researchers will measure symptoms as well as biological markers in blood, urine, and stool samples over time. You may be eligible if you are aged 18 to 65, have a body weight over 50 kg, and are in good general health. You must be willing to avoid all dairy products for the duration of the study. People with gastrointestinal conditions (such as inflammatory bowel disease or coeliac disease), dairy allergies, or who are pregnant are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

A single oral dose (300mL) of A1 Protein Free milk taken under fasted conditions (only water for 10 hours) at the MRINZ clinical room following a 7 day washout of dairy products. The dosing is to be w

A single oral dose (300mL) of A1 Protein Free milk taken under fasted conditions (only water for 10 hours) at the MRINZ clinical room following a 7 day washout of dairy products. The dosing is to be witnessed by an investigator, the whole dose must consumed in under 5 minutes. There is a 7 day washout between crossover doses.


Locations(1)

New Zealand

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