Effects of A2 Milk on Gastrointestinal Function in Non-lactose Milk Intolerance
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ClinicalTrials.gov Identifier: NCT03060395 |
Recruitment Status :
Completed
First Posted : February 23, 2017
Last Update Posted : April 28, 2020
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Condition or disease | Intervention/treatment | Phase |
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Milk Intolerance | Dietary Supplement: A2 milk 100 Dietary Supplement: A2 milk 150 Dietary Supplement: A2 milk 200 Dietary Supplement: A2 milk 250 Dietary Supplement: A1/A2 milk 100 Dietary Supplement: A1/A2 milk 150 Dietary Supplement: A1/A2 milk 200 Dietary Supplement: A1/A2 milk 250 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 37 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | Effects of A2 Milk on Gastrointestinal Function of Volunteers Affected by Non-lactose Milk Intolerance |
Actual Study Start Date : | April 1, 2017 |
Actual Primary Completion Date : | April 30, 2018 |
Actual Study Completion Date : | March 31, 2019 |

Arm | Intervention/treatment |
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Sham Comparator: A1/A2 milk
Commercial conventional A1/A2 semi-skimmed fresh pasteurised cow milk. Progressive intake of intervention milk as follows:
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Dietary Supplement: A1/A2 milk 100
Days 1 and 2: 100 mL A1/A2 milk twice a day Dietary Supplement: A1/A2 milk 150 Days 3 and 4: 150 mL A1/A2 milk twice a day Dietary Supplement: A1/A2 milk 200 Days 5 and 6: 200 mL A1/A2 milk twice a day Dietary Supplement: A1/A2 milk 250 Days 7 to14: 250 mL A1/A2 milk twice a day |
Active Comparator: A2 milk
Commercial A2 semi-skimmed fresh pasteurised cow milk. Progressive intake of intervention milk as follows:
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Dietary Supplement: A2 milk 100
Days 1 and 2: 100 mL A2 milk twice a day Dietary Supplement: A2 milk 150 Days 3 and 4: 150 mL A2 milk twice a day Dietary Supplement: A2 milk 200 Days 5 and 6: 200 mL A2 milk twice a day Dietary Supplement: A2 milk 250 Days 7 to 14: 250 mL A2 milk twice a day |
- Change in gastrointestinal inflammation indicated by fecal calprotectin [ Time Frame: baseline, 14 days, 28 days, 42 days and 56 days ]Measurement of fecal calprotectin (ug/g feces)
- Change in NMR-based urinary metabolic profiles [ Time Frame: baseline, 14 days, 28 days, 42 days and 56 days ]Measured using High Resolution 700MHz proton NMR spectroscopy (Bruker) (no unit)
- Change in NMR-based plasma metabolic profiles [ Time Frame: baseline, 14 days, 28 days, 42 days and 56 days ]Measured using High Resolution 700MHz proton NMR spectroscopy (Bruker) (no unit)
- Change in NMR-based fecal metabolic profiles [ Time Frame: baseline, 14 days, 28 days, 42 days and 56 days ]Measured using High Resolution 700MHz proton NMR spectroscopy (Bruker) (no unit)
- Change in gut microbiota ecosystem assessed by sequencing the 16S rDNA extracted from feces [ Time Frame: baseline, 14 days, 28 days, 42 days and 56 days ]Measures relative abundance of bacterial taxa
- Change in systemic inflammation indicated by circulating levels of high sensitivity C-reactive protein [ Time Frame: baseline, 14 days, 28 days, 42 days and 56 days ]hs-CRP in mg/L
- Change in gastrointestinal function assessed using visual analogue scale for GI symptoms [ Time Frame: 14 days ]Measures gases, bloating, abdominal cramps, diarrhoea, headache, constipation, nausea and rash
- 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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Ages Eligible for Study: | 18 Years to 56 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- BMI: 20-35kg/m2
- Glucose<7mmol/l (not diagnosed with diabetes)
- Total cholesterol<7mmol/l
- Triacylglycerol<4mmol/l
- Normal liver and kidney function
- Regular milk drinker with self-reported intolerance to commercial milk.
- Suffered from mild to moderate digestive discomfort after milk consumption.
- Have normal blood pressure 120/80 mmHg (BP <160/90 mmHg can be accepted) during quiet respiration.
- Agree not to take any medication, supplements and other dairy products including acidophilus milk
- Be willing to comply with all the requirements and procedures of the study.
- Agree to sign the informed consent form;
- Agree not to enrol in another interventional clinical research study while participating in this study.
- Fully understand the nature, objective, benefit and the potential risks and side effects of the study.
Exclusion Criteria:
- Females who are pregnant or planning to be a pregnant and lactating.
- Have known dairy allergy.
- Have stopped drinking milk for the last 6 month.
- Have history of lactose intolerance
- Have history of faecal impaction.
- Received antibiotics in the previous six months
- Smoker
- Anemia
- Trying to lose weight by following a diet or exercise regimen designed for weight loss, or taking any drug influencing appetite and any drug for weight loss for the last three months.
- Have participated in similar dairy or probiotics-containing product's clinical trials within 3 months before the screening.
- Currently taking medicines for cardiovascular or metabolic disease.
- History of alcohol or drug misuse.
- Have history of or be diagnosed of any of the following diseases that may affect the study results: gastrointestinal disorders, hepatopathy, nephropathy, endocrine disease, blood disorders, respiratory, cardiovascular diseases and known on-going allergy such as asthma.
- Currently suffering from any gastrointestinal disorders or gastrointestinal disease, including irritable bowel syndrome, colitis, ulcerative colitis, celiac disease, irritable bowel syndrome (IBS);
- Had hospitalizations within 3 months before screening; Currently drug frequency user of that may affect the gastrointestinal function or immune system. As judged by investigator.
- Who take medication at least the last 6-month.
- Who do excessive exercise not as part of a weight-loss regime, e.g. athletes.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03060395
United Kingdom | |
Department of Food and Nutritional Sciences | |
Reading, Berkshire, United Kingdom, RG6 6AP |
Principal Investigator: | Sandrine P Claus, PhD | University of Reading |
Responsible Party: | Sandrine Claus, Associate Professor in Integrative Metabolism, University of Reading |
ClinicalTrials.gov Identifier: | NCT03060395 |
Other Study ID Numbers: |
A2study |
First Posted: | February 23, 2017 Key Record Dates |
Last Update Posted: | April 28, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | 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). |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Lactose Intolerance Malabsorption Syndromes Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
Carbohydrate Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases |