A2 vs Regular Milk for Lactose Intolerance
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Purdue University
Must not be taking: Antacids, PPIs, Antibiotics, others
Disqualifiers: Milk allergy, Diabetes, IBD, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Cow's milk contains two types of β-casein: A1 and A2. It is evident from human clinical trials that milk with A1 protein produces more hydrogen and symptoms of lactose intolerance. A pro-inflammatory μ-opioid peptide BCM-7 is released from A1 but not from A2. Milk containing A1 β-casein produced more inflammatory markers than A2 β-casein. This is a double-blinded, randomized, controlled trial conducted to determine if there are changes in inflammatory markers following two weeks of milk feeding, due to milk containing A1 and A2 beta-casein as compared to milk containing only A2 beta-casein.
Will I have to stop taking my current medications?
The trial requires participants to stop using treatments and products for dairy intolerance, like Lactaid® Dietary Supplements, during the study. If you are using any other medications, the protocol does not specify, so it's best to discuss with the study staff.
What data supports the effectiveness of A2 milk as a treatment for lactose intolerance?
Research shows that milk containing only A2 beta-casein causes fewer symptoms of lactose intolerance, like abdominal pain, compared to regular milk that contains both A1 and A2 beta-caseins. This suggests that A2 milk may be easier to digest for people with lactose intolerance.
12345Is A2 milk safe for people with lactose intolerance?
Research suggests that A2 milk is generally safe and may cause fewer stomach problems than regular milk for people with lactose intolerance. Studies show that A2 milk leads to fewer digestive symptoms and less discomfort compared to milk containing both A1 and A2 proteins.
12356How does A2 milk differ from other treatments for lactose intolerance?
A2 milk is unique because it contains only A2 beta-casein protein, unlike regular milk which contains both A1 and A2 proteins. This difference may make A2 milk easier to digest for some people with lactose intolerance, as A1 protein is thought to cause digestive discomfort in some individuals.
7891011Eligibility Criteria
Adults aged 18-65 with a history of lactose intolerance who have avoided dairy for at least a month can join. They must be willing to attend all study visits, avoid other dairy intolerance treatments during the trial, and not have conditions like severe ulcers, diabetes, milk allergies, heart failure or recent drug/alcohol abuse.Inclusion Criteria
You have avoided or had problems with dairy products for at least one month.
I agree not to use any products for dairy intolerance during the study.
Able to understand and provide written informed consent in English
+3 more
Exclusion Criteria
Recent bowel preparation for endoscopic or radiologic investigation within four weeks of screening (e.g., colonoscopy prep)
You have used cigarettes, tobacco, or nicotine products within the last 3 months.
I don't have any conditions that could mimic dairy intolerance symptoms.
+20 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Phone screening and in-person hydrogen breath test
Intervention Phase 1
Participants consume the first randomized milk for 14 days and undergo hydrogen breath test on day 15
2 weeks
Daily milk consumption, in-person visit on day 15 for HBT and blood draw
Intervention Phase 2
Participants consume the second randomized milk for 14 days and undergo hydrogen breath test on day 15
2 weeks
Daily milk consumption, in-person visit on day 15 for HBT and blood draw
Follow-up
Participants are monitored for any delayed symptoms or reactions after the intervention phases
4 weeks
Participant Groups
This study is testing how two types of milk affect people with lactose intolerance. One has only A2 beta-casein; the other has both A1 and A2. It's double-blinded (neither researchers nor participants know who gets which milk) and randomized to see if there are differences in inflammation after two weeks.
2Treatment groups
Experimental Treatment
Group I: Old World milkExperimental Treatment1 Intervention
Old World milk containing only a2 beta-casein vs. New World milk that includes both a1 and a2 beta-casein
Group II: New World milkExperimental Treatment1 Intervention
Old World milk containing only a2 beta-casein vs. New World milk that includes both a1 and a2 beta-casein
Milk containing A1 and A2 beta-casein is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Conventional milk for:
- General nutrition
- Dietary supplement
🇺🇸 Approved in United States as Conventional milk for:
- General nutrition
- Dietary supplement
🇨🇦 Approved in Canada as Conventional milk for:
- General nutrition
- Dietary supplement
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Purdue UniversityWest Lafayette, IN
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Who Is Running the Clinical Trial?
Purdue UniversityLead Sponsor
References
Effects of Conventional Milk Versus Milk Containing Only A2 β-Casein on Digestion in Chinese Children: A Randomized Study. [2022]In this study, we hypothesized that replacing conventional milk, which contains A1 and A2 β-casein proteins, with milk that contains only A2 β-casein in the diet of dairy or milk-intolerant preschoolers (age 5 to 6 years) would result in reduced gastrointestinal symptoms associated with milk intolerance, and that this would correspond with cognitive improvements.
Milk Containing A2 β-Casein ONLY, as a Single Meal, Causes Fewer Symptoms of Lactose Intolerance than Milk Containing A1 and A2 β-Caseins in Subjects with Lactose Maldigestion and Intolerance: A Randomized, Double-Blind, Crossover Trial. [2023]Acute-feeding and multiple-day studies have demonstrated that milk containing A2 β-casein only causes fewer symptoms of lactose intolerance (LI) than milk containing both A1 and A2 β-caseins. We conducted a single-meal study to evaluate the gastrointestinal (GI) tolerance of milk containing different concentrations of A1 and A2 β-casein proteins. This was a randomized, double-blind, crossover trial in 25 LI subjects with maldigestion and an additional eight lactose maldigesters who did not meet the QLCSS criteria. Subjects received each of four types of milk (milk containing A2 β-casein protein only, Jersey milk, conventional milk, and lactose-free milk) after overnight fasting. Symptoms of GI intolerance and breath hydrogen concentrations were analyzed for 6 h after ingestion of each type of milk. In an analysis of the 25 LI subjects, total symptom score for abdominal pain was lower following consumption of milk containing A2 β-casein only, compared with conventional milk (p = 0.004). Post hoc analysis with lactose maldigesters revealed statistically significantly improved symptom scores (p = 0.04) and lower hydrogen production (p = 0.04) following consumption of milk containing A2 β-casein only compared with conventional milk. Consumption of milk containing A2 β-casein only is associated with fewer GI symptoms than consumption of conventional milk in lactose maldigesters.
Effects of cow's milk beta-casein variants on symptoms of milk intolerance in Chinese adults: a multicentre, randomised controlled study. [2022]A major protein component of cow's milk is β-casein. The most frequent variants in dairy herds are A1 and A2. Recent studies showed that milk containing A1 β-casein promoted intestinal inflammation and exacerbated gastrointestinal symptoms. However, the acute gastrointestinal effects of A1 β-casein have not been investigated. This study compared the gastrointestinal effects of milk containing A1 and A2 β-casein versus A2 β-casein alone in Chinese adults with self-reported lactose intolerance.
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. [2022]Cows' milk generally contains two types of β-casein, A1 and A2 types. Digestion of A1 type can yield the peptide β-casomorphin-7, which is implicated in adverse gastrointestinal effects of milk consumption, some of which resemble those in lactose intolerance. This study aimed to compare the effects of milk containing A1 β-casein with those of milk containing only A2 β-casein on inflammation, symptoms of post-dairy digestive discomfort (PD3), and cognitive processing in subjects with self-reported lactose intolerance.
Milk Intolerance, Beta-Casein and Lactose. [2018]True lactose intolerance (symptoms stemming from lactose malabsorption) is less common than is widely perceived, and should be viewed as just one potential cause of cows' milk intolerance. There is increasing evidence that A1 beta-casein, a protein produced by a major proportion of European-origin cattle but not purebred Asian or African cattle, is also associated with cows' milk intolerance. In humans, digestion of bovine A1 beta-casein, but not the alternative A2 beta-casein, releases beta-casomorphin-7, which activates μ-opioid receptors expressed throughout the gastrointestinal tract and body. Studies in rodents show that milk containing A1 beta-casein significantly increases gastrointestinal transit time, production of dipeptidyl peptidase-4 and the inflammatory marker myeloperoxidase compared with milk containing A2 beta-casein. Co-administration of the opioid receptor antagonist naloxone blocks the myeloperoxidase and gastrointestinal motility effects, indicating opioid signaling pathway involvement. In humans, a double-blind, randomized cross-over study showed that participants consuming A1 beta-casein type cows' milk experienced statistically significantly higher Bristol stool values compared with those receiving A2 beta-casein milk. Additionally, a statistically significant positive association between abdominal pain and stool consistency was observed when participants consumed the A1 but not the A2 diet. Further studies of the role of A1 beta-casein in milk intolerance are needed.
An approach on detection, quantification, technological properties, and trends market of A2 cow milk. [2023]The genetic variant A2 β-casein integrates the casein protein group in milk and has been often associated with positive health outcomes. Therefore, this review explores the present understanding of A2 β-casein, including detection methods and the market trends for dairy from A2 milk. Also, the interaction of A2 β-casein with αs1-casein and κ-casein genotypes was examined in terms of technological impacts on A2 milk. A limited number of preliminary studies has aimed to investigate the sensorial and technological impacts of β-casein variants in milk matrices, for instance, in yogurt and other derivatives. Nevertheless, considering studies carried out so far, it is concluded that the manufacture of dairy products from A2 milk is perfectly feasible, as the products presented slight differences when compared to those derived from traditional milk. In one of the works, sensitive drops in rennet coagulation time and curd firmness values were observed in cheese traits. However, it is relevant to point out that variant A of κ-casein plays a negative role in the coagulation features of milk. Therefore, alterations in the pattern of cheese-making properties are not uniquely related to β-casein variants. Attempts to produce A2 β-casein in laboratory (non-natural source), through biosynthesis, for example, have not been found so far. This knowledge gap offers a promising area for future studies concerning proteins and bioactive peptide production.
[Importance of the benzylpenicillin nucleus and the side chain of the beta-lactams. Demonstration by skin tests and RAST in penicillin allergic patients]. [2015]We studied 30 patients with beta-Lactams allergy demonstrated by clinical findings. The aim of this work was to determine the capacity of the beta-Lactams nucleus and the side chain in the induction of specific IgE to BPO, Ax, Amp, performed by intradermal skin test and RAST. The patients were divided by clinical manifestations in: 1-Accelerated reactions (n:19); and 2-Immediate reactions (n:11). The Prick tests were performed with BPO-PL, Ax-PL, Amp-PL, MDM-BP, MDM-Ax, MDM-Amp. The accelerated group presented BPO-PL (+) in 2 cases, Ax-PL & Amp-PL (+) in 4 cases, and all of the reactives were (+) in 13 out of 19 cases. The immediate group presented MDM-BP (+) in 10 out of 11 cases and MDM-Amp was (+) in 1 out of 11 cases. The RAST's were performed in all patients(n:30). In accelerated group were (+) to BPO-PL in 13 out of 19 cases, to Ax-PL in 3 out of 19 cases, to Amp-PL in 1 out 19 cases, to BPO-PL and Ax-PL on overlap in 1 out of 19 cases, and 1 case was negative to all reactives. The immediate group presented RAST's negatives in 11 out of 11 cases. The control group(n:20) presented Prick (+) to Ax-PL in 1 out of 20 cases, and the others reactives were negatives in all cases. The RAST's to all reactives were (-) in 20 out of 20 subjects. These results indicate that BPO was the most important determinant, and the side chain of the Ax or Amp were others determinants of the beta-Lactams drugs. These determinants induced specific IgE, and in rare occasions appears specific IgE for two different determinants on overlap in the same patient. The intradermal skin testing is the method of choice to study the penicillin allergies, because non satisfactory RAST's have yet been developed for minor determinant-specific IgE antibodies.
Outcome of drug provocation testing in children with suspected beta-lactam hypersensitivity. [2022]Suspicion of beta-lactam (BL) hypersensitivity is often based on parental report. Evaluation is important as incorrect labelling has clinical consequence.
Clavulanic Acid Is a Leading Culprit Beta-Lactam in Immediate Allergic Reactions to Penicillins. [2023]Clavulanate, a beta-lactam associated with amoxicillin, is frequently prescribed in patients at all ages. Recent data implicate amoxicillin-clavulanate in up to 80% of beta-lactam allergy cases. We assessed clavulanate's role in inducing allergic reactions to this combination treatment, with a focus on selective immediate reactions.
Beta-lactam allergy in the paediatric population. [2021]Beta-lactam allergy is commonly diagnosed in paediatric patients, but over 90% of individuals reporting this allergy are able to tolerate the medications prescribed after evaluation by an allergist. Beta-lactam allergy labels are associated with negative clinical and administrative outcomes, including use of less desirable alternative antibiotics, longer hospitalizations, increasing antibiotic-resistant infections, and greater medical costs. Also, children with true IgE-mediated allergy to penicillin medications are often advised to avoid all beta-lactam antibiotics, including cephalosporins, which is likely unnecessary in greater than 97% of those reporting penicillin allergies. Most patients can be safely treated with penicillin or amoxicillin if they do not have a history compatible with IgE-mediated or systemic, delayed reactions such as Stevens-Johnson syndrome (SJS), serum sickness-like reactions, drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome, or acute generalized exanthematous pustulosis (AGEP). Guidance is provided on how to stratify risk of beta-lactam allergy, and on test dosing and monitoring in the outpatient setting for patients deemed low risk. Guidance for patients at higher risk of beta-lactam allergy includes criteria for appropriate referral to allergists and the use of alternative antimicrobials, such as cephalosporins, while awaiting specialist assessment.
Direct Challenges for the Evaluation of Beta-Lactam Allergy: Evidence and Conditions for Not Performing Skin Testing. [2021]In the western world, up to 10% of the general population and more than 15% of hospitalized patients report penicillin allergy. After a comprehensive evaluation, more than 95% of patients who report a penicillin allergy can subsequently tolerate this antibiotic. Traditionally, the most widely accepted protocol to evaluate beta-lactam (BL) allergy consisted of skin testing (ST) followed by a drug provocation test (DPT) in ST-negative patients. DPT is the gold standard for proving or excluding BL allergy and is considered the final and definitive step in the evaluation. Recently, studies have been published that support the use of direct DPTs without preceding ST for both pediatric and adult patients who report a low-risk historical reaction to BLs. However, these studies use various risk-stratification criteria to determine eligibility for a direct DPT. A standardized protocol for DPT is also lacking. In this review, we assess the current literature and evidence for performing direct DPT in the pediatric and adult populations. On the basis of this evidence, we also present risk-based algorithms for the evaluation of BL allergy in pediatric and adult populations based on a description of the historical reaction.