Clinical trial NCT04468880: Milk Consumption on Digestive Comfort.
Official title: Effect of Milk Consumption, Containing A2 β-caseins Only, on Digestive Comfort. A Randomized and Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: milk intolerant
β-caseins A1 and A2
Lactose
Lead sponsor: Institut Pasteur de Lille
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: monocentric, double-blind, randomized, controlled, cross-over and ambulatory study
Primary purpose: OTHER

Brief summary: 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:

1. 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,
2. 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Analog visual scales
timeFrame: 4 weeks
Secondary outcomes:
measure: Analysis of the average per period of each analog visual scales independently
timeFrame: 4 weeks
measure: Difference Calprotectin at the end of the period - Calprotectin at V0 (measured in mg/kg)
timeFrame: 4 weeks
measure: For each of the inflammatory markers (CRP us, IL-1β, TNF-α, IL-6) : difference between value at the end of the period and value at V0
timeFrame: 4 weeks
measure: Average stool frequencies and consistencies
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Lille
country: France
facility: NutrInvest - Institut Pasteur de Lille
state: Nord
Study officials:
affiliation: Institut Pasteur de Lille - NutrInvest
name: Jean-Michel LECERF, MD
role: PRINCIPAL_INVESTIGATOR
References: