Effects of A2 Milk on Gastrointestinal Function in Non-lactose Milk Intolerance
NCT ID: NCT03060395
Last Updated: 2020-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2017-04-01
2019-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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A1/A2 milk
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
A1/A2 milk 100
Days 1 and 2: 100 mL A1/A2 milk twice a day
A1/A2 milk 150
Days 3 and 4: 150 mL A1/A2 milk twice a day
A1/A2 milk 200
Days 5 and 6: 200 mL A1/A2 milk twice a day
A1/A2 milk 250
Days 7 to14: 250 mL A1/A2 milk twice a day
A2 milk
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
A2 milk 100
Days 1 and 2: 100 mL A2 milk twice a day
A2 milk 150
Days 3 and 4: 150 mL A2 milk twice a day
A2 milk 200
Days 5 and 6: 200 mL A2 milk twice a day
A2 milk 250
Days 7 to 14: 250 mL A2 milk twice a day
Interventions
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A2 milk 100
Days 1 and 2: 100 mL A2 milk twice a day
A2 milk 150
Days 3 and 4: 150 mL A2 milk twice a day
A2 milk 200
Days 5 and 6: 200 mL A2 milk twice a day
A2 milk 250
Days 7 to 14: 250 mL A2 milk twice a day
A1/A2 milk 100
Days 1 and 2: 100 mL A1/A2 milk twice a day
A1/A2 milk 150
Days 3 and 4: 150 mL A1/A2 milk twice a day
A1/A2 milk 200
Days 5 and 6: 200 mL A1/A2 milk twice a day
A1/A2 milk 250
Days 7 to14: 250 mL A1/A2 milk twice a day
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
56 Years
ALL
Yes
Sponsors
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University of Reading
OTHER
Responsible Party
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Sandrine Claus
Associate Professor in Integrative Metabolism
Principal Investigators
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Sandrine P Claus, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Reading
Locations
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Department of Food and Nutritional Sciences
Reading, Berkshire, United Kingdom
Countries
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References
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Ul Haq MR, Kapila R, Sharma R, Saliganti V, Kapila S. Comparative evaluation of cow beta-casein variants (A1/A2) consumption on Th2-mediated inflammatory response in mouse gut. Eur J Nutr. 2014 Jun;53(4):1039-49. doi: 10.1007/s00394-013-0606-7. Epub 2013 Oct 29.
Ho S, Woodford K, Kukuljan S, Pal S. Comparative effects of A1 versus A2 beta-casein on gastrointestinal measures: a blinded randomised cross-over pilot study. Eur J Clin Nutr. 2014 Sep;68(9):994-1000. doi: 10.1038/ejcn.2014.127. Epub 2014 Jul 2.
Jianqin S, Leiming X, Lu X, Yelland GW, Ni J, Clarke AJ. Effects of milk containing only A2 beta casein versus milk containing both A1 and A2 beta casein proteins on gastrointestinal physiology, symptoms of discomfort, and cognitive behavior of people with self-reported intolerance to traditional cows' milk. Nutr J. 2016 Apr 2;15:35. doi: 10.1186/s12937-016-0147-z.
Johnson AO, Semenya JG, Buchowski MS, Enwonwu CO, Scrimshaw NS. Correlation of lactose maldigestion, lactose intolerance, and milk intolerance. Am J Clin Nutr. 1993 Mar;57(3):399-401. doi: 10.1093/ajcn/57.3.399.
Other Identifiers
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A2study
Identifier Type: -
Identifier Source: org_study_id
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