NCT06763185

A1 Beta-casein-free Milk in Milk-intolerant Participants

Comparative Effects of Conventional Cow's Milk Versus Milk Free of A1-type Beta-casein on Gastrointestinal Physiology and Symptoms of Digestive Discomfort in Participants Intolerant to Conventional Cow's Milk: a Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: a2 Milk Company Ltd. · Industry
• Sex: All
• Age: 18 Years – 68 Years
• Healthy volunteers: Not accepted

Summary

This was a single-site, double-blind, randomised, controlled, crossover study, which aimed to compare the effects of conventional cow's milk (CON, containing both A1- and A2-types of beta-casein) versus milk free of A1-type beta-casein (A1PF milk) on gastrointestinal (GI) physiology and symptoms of digestive discomfort in non-regular milk drinkers with self-reported intolerance to conventional cow's milk. The study location was the Pennington Biomedical Research Center in Louisiana, USA. The study comprised a 2-week washout period, 2 weeks of milk consumption, crossover, a second 2-week washout period, and a second 2-week period of milk consumption. Eligible participants were stratified by sex to achieve an approximate 1:1 male to female ratio and were randomised to receive conventional cow's milk (sequence 1) or A1PF milk (sequence 2) during the first period of milk consumption. During the second period of milk consumption, participant groups underwent crossover to receive the alternate study milk. Milk was consumed three times per day after meals, with 250 mL provided at each administration. During washout periods, participants were required to avoid all dairy products and use only rice milk to replace any normal dairy intake, and to avoid foods with very high fermentable oligosaccharides, disaccharides, monosaccharides, and polyols content, to avoid potential confounding of the symptoms experienced. Any medication, nutritional supplements, dairy products, acidophilus milk, or probiotics were prohibited during the study. The study protocol and all related documentation were approved by the Pennington Biomedical Research Center Institution Review Board. The study was conducted in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice Guidelines of the International Conference on Harmonisation. All participants provided written informed consent prior to initiating any study procedures.

Conditions

• Digestive Discomfort

Interventions

Type	Name	Description
OTHER	Dietary Supplement: conventional cow's milk consumption, and then A1PF milk consumption	Milk was consumed three times per day after meals, with 250 mL provided at each administration. During washout periods, participants were required to avoid all dairy products and use only rice milk.
OTHER	Dietary Supplement: A1PF milk consumption, and then conventional cow's milk consumption	Milk was consumed three times per day after meals, with 250 mL provided at each administration. During washout periods, participants were required to avoid all dairy products and use only rice milk.

Timeline

• Start date: 2017-04-28
• Primary completion: 2019-03-27
• Completion: 2019-03-27
• First posted: 2025-01-08
• Last updated: 2025-01-08

Locations

1 site across 1 country: United States