Milk Consumption on Digestive Comfort.

NCT04468880 | Completed

• 1 other identifier: 2020-A00185-34
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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. 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. 2.consumption of A2 milk significantly reduces gastrointestinal symptoms and improves digestive comfort in lactose intolerant people.

Conditions

Healthy Volunteers

Keywords

milk intolerant; β-caseins A1 and A2; Lactose

Outcome Measures

Primary Outcomes (1)

• Analog visual scales

  Digestive comfort will be assessed daily by the average of the following analog visual scales (score : 0 to 10), completed within 30 min to 3 hours after consumption of the daily dose of milk, depending on the usual occurrence of symptoms in individuals: * I have bloating * I have abdominal pain * I have flatulence (gas) * I have borborygmas (gurgling) * I have reflux (return, rise) * Overall, I estimate my digestive comfort. The average of these 6 analog visual scales, called Global Digestive Discomfort (IDG), will therefore be available every day for 14 days; the final variable analyzed will be the average of these 14 IDG values, and will be called Global Average Digestive Discomfort (IDGM).

  4 weeks

Secondary Outcomes (4)

• Analysis of the average per period of each analog visual scales independently

  4 weeks

• Difference Calprotectin at the end of the period - Calprotectin at V0 (measured in mg/kg)

  4 weeks

• 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

  4 weeks

• Average stool frequencies and consistencies

  4 weeks

Study Arms (2)

Milk A1A2

OTHER

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

Other: Group (A1 → A2)

Milk A2A2

OTHER

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

Other: Group (A2 → A1)

Interventions

Group (A1 → A2) 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 A1A2

Group (A2 → A1) 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.

Milk A2A2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Man or woman;
• 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.

You may not qualify if:

• 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 with immunodeficiency or any other serious pathology (cancer, hemopathy);
• Pregnant or planning to be pregnant during the study period;
• 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.

Sponsors & Collaborators

• Institut Pasteur de Lille: lead

Study Sites (1)

NutrInvest - Institut Pasteur de Lille

Lille, Nord, 59019, France

Location

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Jean-Michel LECERF, MD

  Institut Pasteur de Lille - NutrInvest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD in nutrition and endocrinology

Model Details: monocentric, double-blind, randomized, controlled, cross-over and ambulatory study

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 13, 2020
• Study Start: July 20, 2020
• Primary Completion: April 14, 2021
• Study Completion: June 1, 2021
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

FR (1)