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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
37
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
Department of Food and Nutritional Sciences
Reading, Berkshire, United Kingdom
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
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