Milk Consumption on Digestive Comfort. (A2-DIGEST)

Pasteur Institute of Lille (IPL)

Status

Completed

Conditions

Healthy Volunteers

Treatments

Other: Group (A1 → A2)

Other: Group (A2 → A1)

Study type

Interventional

Funder types

Other

Identifiers

NCT04468880

2020-A00185-34

Details and patient eligibility

About

Lactose, naturally present in milk, can cause digestive discomfort. Delactosed milk is currently the only one alternative to cow's milk for intolerant people. As some of them do not digest milk, it was completely remove from their diet. However, are they really intolerant to lactose or intolerant to milk (or to another of its compounds)? Do β-caseins play a role in this intolerance? β-caseins are proteins naturally present in milk. Two types of β-caseins were identified: A1 and A2. These types differ according to the genetic profile of the cow and depend on the breed. The rare clinical studies interested in this topic suggest that:

consumption of milk A1 versus consumption of milk A2 can lead to: softer stools, delayed transit, as well as pro-inflammatory effects in some individuals,
consumption of A2 milk significantly reduces gastrointestinal symptoms and improves digestive comfort in lactose intolerant people.

Thus, it would be interesting to be able to assess the effect of a consumption of A2A2 milk type compared to A1A2 milk type, both on the parameters of digestive comfort and on inflammatory parameters.

Full description

The study will be carried out on healthy volunteers, aged 18 to 65 and self-declared sensitive, even intolerant to the consumption of milk.

The main objective of the study is to assess the impact of milk β-caseins (A2A2 vs A1A2) on the digestive comfort felt during the consumption of milk in subjects declaring that they do not tolerate milk.

Enrollment

50 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Man or woman;
18 to 65 years old;
Declaring to have sensitivity or intolerance when consuming cow's milk;
Agreeing to follow the constraints generated by the study;
Having signed the informed consent form;
Social insured.

Exclusion criteria

Subject with an allergy to cow's milk proteins;
Subject suffering from a severe eating disorder (anorexia, bulimia, binge eating);
Subject with chronic pathology interfering with the parameters studied during this study (inflammatory intestinal disease, celiac disease);
Subject suffering from acute intestinal infection at the time of inclusion (gastroenteritis, etc.);
Subject with immunodeficiency or any other serious pathology (cancer, hemopathy);
Pregnant or planning to be pregnant during the study period;
Subject participating in another clinical study or in period of exclusion from another study;
Subject deprived of liberty;
Subject under judicial protection measure;
Whose main investigator or a qualified co-investigator judges that the state of health or the concomitant treatments are not compatible with the good progress of the clinical study.