An interventional study of A2 milk 100 and A2 milk 150 in Milk Intolerance, sponsored by University of Reading. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 56 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-28.
Sponsored by University of Reading · Not applicable, Interventional, and Basic science
There is increasing evidence that a number of people experience moderate milk intolerance characterised by increased gas production, bloating and abdominal cramp, which can neither be attributed to lactose intolerance, nor to milk protein allergy. Milk digestion can lead to the formation of bioactive peptides, one of which derived from a mutated gene variant (A1) coding for milk beta-casein has been associated with increased gastrointestinal inflammation and poor gastrointestinal function. In this study, we hypothesise that consumption of non-mutated A2 milk will improve gastrointestinal symptoms in non-lactose milk intolerant individuals.
Non-lactose milk intolerance is a condition that has not been defined clinically yet but the current literature reports existence of subjects who are moderately milk intolerant and whose intolerance can neither be attributed to a defect in lactose intolerance, nor to milk protein allergy. Yet, they experience at least one or two of the following symptoms following milk consumption: gases, bloating, abdominal cramp. It is known that the A1gene variant coding for beta-casein leads to the production of a bioactive peptide with opioid activity named betacasomorphin 7 (BCM7). This peptide has been associated with several metabolic health disorders including diabetes, elevated cardiovascular risk and stimulation of pro-inflammatory signals. Recently, it was reported that non-lactose milk intolerant subjects did not experience such symptoms when consuming milk containing the non-mutated A2 gene variant coding for beta-casein. In this study, we hypothesise that consumption of A2 milk will improve gastrointestinal symptoms in non-lactose milk intolerant individuals. The primary outcome of this study will be the reduction of gastrointestinal inflammation following a course of A2 milk consumption.
53 studies on the registry are indexed under Lactose Intolerance; 6 are open to participants now.
This study's enrollment of 37 is close to the median of 41 across 41 interventional studies indexed under Lactose Intolerance.
Browse Lactose Intolerance studies →University of Reading is the lead sponsor of 150 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Commercial conventional A1/A2 semi-skimmed fresh pasteurised cow milk. Progressive intake of intervention milk as follows: * Days 1 and 2: 100 mL twice a day * Days 3 and 4: 150 mL twice a day * Days 5 and 6: 200 mL twice a day * Days 7 to 14: 250 mL twice a day
Dietary Supplement: A1/A2 milk 100 · Dietary Supplement: A1/A2 milk 150 · Dietary Supplement: A1/A2 milk 200 · Dietary Supplement: A1/A2 milk 250
Commercial A2 semi-skimmed fresh pasteurised cow milk. Progressive intake of intervention milk as follows: * Days 1 and 2: 100 mL twice a day * Days 3 and 4: 150 mL twice a day * Days 5 and 6: 200 mL twice a day * Days 7 to 14: 250 mL twice a day
Dietary Supplement: A2 milk 100 · Dietary Supplement: A2 milk 150 · Dietary Supplement: A2 milk 200 · Dietary Supplement: A2 milk 250
Days 1 and 2: 100 mL A2 milk twice a day
Days 3 and 4: 150 mL A2 milk twice a day
Days 5 and 6: 200 mL A2 milk twice a day
Days 7 to 14: 250 mL A2 milk twice a day
Days 1 and 2: 100 mL A1/A2 milk twice a day
Days 3 and 4: 150 mL A1/A2 milk twice a day
Days 5 and 6: 200 mL A1/A2 milk twice a day
Days 7 to14: 250 mL A1/A2 milk twice a day
Change in gastrointestinal inflammation indicated by fecal calprotectin
Measurement of fecal calprotectin (ug/g feces)
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Change in NMR-based urinary metabolic profiles
Measured using High Resolution 700MHz proton NMR spectroscopy (Bruker) (no unit)
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Change in NMR-based plasma metabolic profiles
Measured using High Resolution 700MHz proton NMR spectroscopy (Bruker) (no unit)
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Change in NMR-based fecal metabolic profiles
Measured using High Resolution 700MHz proton NMR spectroscopy (Bruker) (no unit)
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Change in gut microbiota ecosystem assessed by sequencing the 16S rDNA extracted from feces
Measures relative abundance of bacterial taxa
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Change in systemic inflammation indicated by circulating levels of high sensitivity C-reactive protein
hs-CRP in mg/L
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Change in gastrointestinal function assessed using visual analogue scale for GI symptoms
Measures gases, bloating, abdominal cramps, diarrhoea, headache, constipation, nausea and rash
Time frame: 14 days
Height (in m) used to detect change in BMI (kg/m^2)
Time frame: baseline
Weight (in kg) used to detect change in BMI (kg/m^2)
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Change in systolic blood pressure in mmHg
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Change in diastolic blood pressure in mmHg
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Diagnostic of lactose intolerance by breath hydrogen concentration following ingestion of 25g lactose in 250 mL water
Time frame: screening visit, 14 days, 42 days and 56 days
Diagnostic of lactose intolerance by breath methane concentration following ingestion of 25g lactose in 250 mL water
Time frame: screening visit, 14 days, 42 days and 56 days
Self-reported change in gut transit time
Time frame: 14 days, 42 days and 56 days
Monitoring of changes in psychological behaviour assessed by TMT
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Monitoring of changes in psychological behaviour assessed by Letter Memory Test
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Monitoring of changes in psychological behaviour assessed by Flanger Test
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Monitoring of changes in mood measured by PANAS questionnaire
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Change in stool consistency using the Bristol stool chart
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Plan to share: No — We do not plan to share IPD with other researchers outside the University of Reading. Anonymous data may be made available upon publication of the study outcome in appropriate repositories (e.g. metabolomic profiles).
Ran from Apr 2017 to primary completion in Apr 2018, 12 months.
Of 22 interventional studies with no phase under Lactose Intolerance, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's 12 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.