NCT03060395

Effects of A2 Milk on Gastrointestinal Function in Non-lactose Milk Intolerance

Effects of A2 Milk on Gastrointestinal Function of Volunteers Affected by Non-lactose Milk Intolerance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: University of Reading · Academic / Other
• Sex: All
• Age: 18 Years – 56 Years
• Healthy volunteers: Accepted

Summary

There is increasing evidence that a number of people experience moderate milk intolerance characterised by increased gas production, bloating and abdominal cramp, which can neither be attributed to lactose intolerance, nor to milk protein allergy. Milk digestion can lead to the formation of bioactive peptides, one of which derived from a mutated gene variant (A1) coding for milk beta-casein has been associated with increased gastrointestinal inflammation and poor gastrointestinal function. In this study, we hypothesise that consumption of non-mutated A2 milk will improve gastrointestinal symptoms in non-lactose milk intolerant individuals.

Detailed description

Non-lactose milk intolerance is a condition that has not been defined clinically yet but the current literature reports existence of subjects who are moderately milk intolerant and whose intolerance can neither be attributed to a defect in lactose intolerance, nor to milk protein allergy. Yet, they experience at least one or two of the following symptoms following milk consumption: gases, bloating, abdominal cramp. It is known that the A1gene variant coding for beta-casein leads to the production of a bioactive peptide with opioid activity named betacasomorphin 7 (BCM7). This peptide has been associated with several metabolic health disorders including diabetes, elevated cardiovascular risk and stimulation of pro-inflammatory signals. Recently, it was reported that non-lactose milk intolerant subjects did not experience such symptoms when consuming milk containing the non-mutated A2 gene variant coding for beta-casein. In this study, we hypothesise that consumption of A2 milk will improve gastrointestinal symptoms in non-lactose milk intolerant individuals. The primary outcome of this study will be the reduction of gastrointestinal inflammation following a course of A2 milk consumption.

Conditions

• Milk Intolerance

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	A2 milk 100	Days 1 and 2: 100 mL A2 milk twice a day
DIETARY_SUPPLEMENT	A2 milk 150	Days 3 and 4: 150 mL A2 milk twice a day
DIETARY_SUPPLEMENT	A2 milk 200	Days 5 and 6: 200 mL A2 milk twice a day
DIETARY_SUPPLEMENT	A2 milk 250	Days 7 to 14: 250 mL A2 milk twice a day
DIETARY_SUPPLEMENT	A1/A2 milk 100	Days 1 and 2: 100 mL A1/A2 milk twice a day
DIETARY_SUPPLEMENT	A1/A2 milk 150	Days 3 and 4: 150 mL A1/A2 milk twice a day
DIETARY_SUPPLEMENT	A1/A2 milk 200	Days 5 and 6: 200 mL A1/A2 milk twice a day
DIETARY_SUPPLEMENT	A1/A2 milk 250	Days 7 to14: 250 mL A1/A2 milk twice a day

Timeline

• Start date: 2017-04-01
• Primary completion: 2018-04-30
• Completion: 2019-03-31
• First posted: 2017-02-23
• Last updated: 2020-04-28

Locations

1 site across 1 country: United Kingdom