Healthy VolunteersA2-DIGESTNCT04468880
Milk Consumption on Digestive Comfort.
A study testing Group (A1 → A2) and Group (A2 → A1) in people with Healthy Volunteers, run by Institut Pasteur de Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Group (A1 → A2) and Group (A2 → A1)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jul 2020to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Milk Consumption, Containing A2 β-caseins Only, on Digestive Comfort. A Randomized and Double-blind Study
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.
Read the 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
- Being tested
- Group (A1 → A2), Group (A2 → A1)
- Keywords
- milk intolerant, β-caseins A1 and A2, Lactose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Milk A1A2 | Other | Group (A1 → A2) receiving control milk A1A2 in period 1 then the milk evaluated A2A2 in period 2 Receives: 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 Receives: Other: Group (A2 → A1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 weeks
Secondary outcomes (4)
Analysis of the average per period of each analog visual scales independently
The analogue visual scales will be completed daily during each period of milk consumption (4 weeks)
Measured: 4 weeks
Difference Calprotectin at the end of the period - Calprotectin at V0 (measured in mg/kg)
Stool collections are made during inclusion visits, V1 follow-up and V3 end of study.
Measured: 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
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.
Measured: 4 weeks
Average stool frequencies and consistencies
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)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start20 Jul 2020
- Primary completion14 Apr 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- monocentric, double-blind, randomized, controlled, cross-over and ambulatory study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur de Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Michel Lecerf, Institut Pasteur de Lille
- Investigators
- Jean-Michel LECERF, MD, Principal investigator, Institut Pasteur de Lille - NutrInvest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468880
- Sponsor's protocol ID
- 2020-A00185-34
- Acronym
- A2-DIGEST
- Status last verified
- Apr 2022
- First submitted
- 9 Jul 2020
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Milk Consumption, Containing A2 β-caseins Only, on Digestive Comfort. A Randomized and Double-blind Study
- ClinicalTrials.gov ID
- NCT04468880
- Acronym / sponsor ID
- A2-DIGEST / 2020-A00185-34
- Conditions
- Healthy Volunteers
- Keywords
- milk intolerant, β-caseins A1 and A2, Lactose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Institut Pasteur de LilleUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 14 Apr 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- monocentric, double-blind, randomized, controlled, cross-over and ambulatory study
| Arm | Type | Receives |
|---|---|---|
| Milk A1A2 | Other | Other: Group (A1 → A2)Group (A1 → A2) receiving control milk A1A2 in period 1 then the milk evaluated A2A2 in period 2 |
| Milk A2A2 | Other | Other: Group (A2 → A1)Group (A2 → A1) receiving the milk evaluated A2A2 in period 1 then the control milk A1A2 in period 2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Milk A1A2 |
| 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. | Other | Milk A2A2 |
Primary outcome
Analog visual scales
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: * 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 secondary outcomes
Analysis of the average per period of each analog visual scales independently
Time frame: 4 weeks
Difference Calprotectin at the end of the period - Calprotectin at V0 (measured in mg/kg)
Time frame: 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
Time frame: 4 weeks
Average stool frequencies and consistencies
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Michel LECERF, MD principal investigator
Institut Pasteur de Lille - NutrInvest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group (A1 → A2) and Group (A2 → A1) in people with Healthy Volunteers, run by Institut Pasteur de Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analog visual scales (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.