Department of Food and Nutritional Sciences
Reading, Berkshire, RG6 6AP, United Kingdom
NCT Number: NCT03060395
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.
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Notify Me18 year–56 year
All sexes
Interventional
Not applicable
Reading, Berkshire, RG6 6AP, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Measurement of fecal calprotectin (ug/g feces)
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Measured using High Resolution 700MHz proton NMR spectroscopy (Bruker) (no unit)
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Measured using High Resolution 700MHz proton NMR spectroscopy (Bruker) (no unit)
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Measured using High Resolution 700MHz proton NMR spectroscopy (Bruker) (no unit)
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Measures relative abundance of bacterial taxa
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
hs-CRP in mg/L
Time frame: 14 days
Measures gases, bloating, abdominal cramps, diarrhoea, headache, constipation, nausea and rash
Time frame: baseline
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Time frame: screening visit, 14 days, 42 days and 56 days
Time frame: screening visit, 14 days, 42 days and 56 days
Time frame: 14 days, 42 days and 56 days
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
Time frame: baseline, 14 days, 28 days, 42 days and 56 days
University of Reading
Other
Effects of A2 Milk on Gastrointestinal Function of Volunteers Affected by Non-lactose Milk Intolerance
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