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

NCT ID: NCT06763185

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-28
• Study Completion Date: 2019-03-27

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Sequence 1

Sequence 1: a 2-week washout period, 2 weeks of conventional cow's milk consumption, crossover, a second 2-week washout period, and a second 2-week period of A1PF milk consumption.

Group Type: OTHER

Dietary Supplement: conventional cow's milk consumption, and then A1PF milk consumption

Intervention Type: OTHER

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.

Sequence 2

Sequence 2: a 2-week washout period, 2 weeks of A1PF milk consumption, crossover, a second 2-week washout period, and a second 2-week period of conventional cow's milk consumption.

Group Type: OTHER

Dietary Supplement: A1PF milk consumption, and then conventional cow's milk consumption

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male or female participants aged 18 to 68 years
• Irregularly consumed milk
• Had self-reported mild-to-moderate digestive discomfort after milk consumption
• Had normal electrocardiograms and blood pressure during quiet respiration

Exclusion Criteria

• Known allergies to dairy products
• Severe milk intolerance
• A history of faecal impaction
• Having suffered from GI disorders (e.g., irritable bowel syndrome, colitis, ulcerative colitis, or coeliac disease)
• Currently being administered drugs for cardiovascular or metabolic disease
• Trying to lose weight by following a diet or exercise regimen
• Took any appetite or weight loss drugs for the previous three months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

a2 Milk Company Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Countries

United States

Other Identifiers

1016-065 Milk

Identifier Type: -

Identifier Source: org_study_id