Milk Consumption on Digestive Comfort.

NCT ID: NCT04468880

Last Updated: 2022-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-20
• Study Completion Date: 2021-06-01

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.

Conditions

Healthy Volunteers

Study Design

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

Study Groups

Milk A1A2

Group (A1 → A2) receiving control milk A1A2 in period 1 then the milk evaluated A2A2 in period 2

Group Type: OTHER

Group (A1 → A2)

Intervention Type: OTHER

Before each start of consumption of the products under study, a wash-out period of 2 weeks (no consumption of milk) must be observed by the subjects.

25 subjects will consume A1A2 milk for 2 weeks (period 1), then they will consume A2A2 milk for 2 weeks (period 2).

During each consumption period, various questionnaires will be completed by the subjects: frequency and consistency of stool, analog visual scales on digestive comfort and dietary surveys. Stool collections will also be carried out.

Milk A2A2

Group (A2 → A1) receiving the milk evaluated A2A2 in period 1 then the control milk A1A2 in period 2

Group Type: OTHER

Group (A2 → A1)

Intervention Type: OTHER

Before each start of consumption of the products under study, a wash-out period of 2 weeks (no consumption of milk) must be observed by the subjects.

25 subjects will consume A2A2 milk for 2 weeks (period 1), then they will consume A1A2 milk for 2 weeks (period 2).

During each consumption period, various questionnaires will be completed by the subjects: frequency and consistency of stool, analog visual scales on digestive comfort and dietary surveys. Stool collections will also be carried out.

Interventions

Group (A1 → A2)

Before each start of consumption of the products under study, a wash-out period of 2 weeks (no consumption of milk) must be observed by the subjects.

25 subjects will consume A1A2 milk for 2 weeks (period 1), then they will consume A2A2 milk for 2 weeks (period 2).

During each consumption period, various questionnaires will be completed by the subjects: frequency and consistency of stool, analog visual scales on digestive comfort and dietary surveys. Stool collections will also be carried out.

Intervention Type: OTHER

Group (A2 → A1)

Before each start of consumption of the products under study, a wash-out period of 2 weeks (no consumption of milk) must be observed by the subjects.

25 subjects will consume A2A2 milk for 2 weeks (period 1), then they will consume A1A2 milk for 2 weeks (period 2).

During each consumption period, various questionnaires will be completed by the subjects: frequency and consistency of stool, analog visual scales on digestive comfort and dietary surveys. Stool collections will also be carried out.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut Pasteur de Lille

OTHER

Sponsor Role: lead

Responsible Party

Jean-Michel Lecerf

MD in nutrition and endocrinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean-Michel LECERF, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Pasteur de Lille - NutrInvest

Locations

NutrInvest - Institut Pasteur de Lille

Lille, Nord, France

Countries

France

Other Identifiers

2020-A00185-34

Identifier Type: -

Identifier Source: org_study_id