NutrInvest - Institut Pasteur de Lille
Lille, Nord, 59019, France
NCT Number: NCT04468880
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Lille, Nord, 59019, France
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 4 weeks
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:
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).
Time frame: 4 weeks
The analogue visual scales will be completed daily during each period of milk consumption (4 weeks)
Time frame: 4 weeks
Stool collections are made during inclusion visits, V1 follow-up and V3 end of study.
Time frame: 4 weeks
Blood samples are taken during inclusion visits, V1 follow-up and V3 end of study.
All of the inflammatory markers are measured in pg/ml.
Time frame: 4 weeks
This questionnaires will be completed daily during each period of milk consumption (4 weeks).
Bristol scale: stool type 1 (separate hard balls) to stool type 7 (watery, structureless stools)
Institut Pasteur de Lille
Other
Effect of Milk Consumption, Containing A2 β-caseins Only, on Digestive Comfort. A Randomized and Double-blind Study
Acronym: A2-DIGEST
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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