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Protein
A2 Milk for Lactose Intolerance
N/A
Recruiting
Led By Dennis Savaiano, PhD
Research Sponsored by Purdue University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 18 to 65 years of age inclusive at screening
Agrees to refrain from all other treatments and products used for dairy intolerance (e.g., Lactaid® Dietary Supplements) during study involvement
Must not have
Weighing <16.5 kg and BMI > 35 kg/m2
Currently undergoing chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within the 6 hours following milk dose
Awards & highlights
No Placebo-Only Group
Summary
This trial found that A1 β-casein milk causes more inflammation than A2 β-casein milk, suggesting A2 may be easier to digest.
Who is the study for?
This trial is for adults aged 18-65 who have a history of dairy intolerance and have avoided dairy for at least a month. Participants must be non-smokers, not pregnant or lactating, without recent drug abuse, and free from certain medical conditions like diabetes, heart failure, gastrointestinal surgeries that affect digestion, or any immune disorders.
What is being tested?
The study tests whether milk containing A1 beta-casein increases inflammation compared to milk with only A2 beta-casein in people with dairy intolerance. It's a controlled experiment where participants are randomly assigned to receive one type of milk without knowing which one it is (double-blinded).
What are the potential side effects?
Potential side effects may include symptoms typically associated with lactose intolerance such as gas, bloating, cramps, stomach pain and diarrhea. There might also be an increase in inflammatory markers specific to individuals sensitive to A1 beta-casein.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Select...
I agree not to use any treatments or products for dairy intolerance during the study.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I weigh less than 16.5 kg and my BMI is over 35.
Select...
I am currently receiving chemotherapy.
Select...
I have been diagnosed with congestive heart failure.
Select...
I do not have HIV, Hepatitis B, or Hepatitis C.
Select...
I have active ulcers or a history of severe ulcers.
Select...
I regularly use antacids or proton pump inhibitors.
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I have diabetes (type 1 or type 2).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within the 6 hours following milk dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within the 6 hours following milk dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Difference in hydrogen between commercial and A2 milk
Difference in inflammation between commercial and A2 milk
Difference in symptoms between commercial and A2 milk
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Find a Location
Who is running the clinical trial?
Purdue UniversityLead Sponsor
233 Previous Clinical Trials
71,338 Total Patients Enrolled
3 Trials studying Lactose Intolerance
80 Patients Enrolled for Lactose Intolerance
Dennis Savaiano, PhDPrincipal InvestigatorPurdue University
4 Previous Clinical Trials
928 Total Patients Enrolled
3 Trials studying Lactose Intolerance
80 Patients Enrolled for Lactose Intolerance
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of digestive system diseases that could affect study results.I have had a high colonic enema in the last 30 days.I weigh less than 16.5 kg and my BMI is over 35.You have avoided dairy or had trouble tolerating dairy in the past month.I am currently receiving chemotherapy.You have smoked cigarettes or used other tobacco or nicotine products in the last 3 months.I have a condition like gastroparesis or Parkinson's that affects my stomach's movement.I have been diagnosed with congestive heart failure.I do not have HIV, Hepatitis B, or Hepatitis C.I haven't used products for dairy intolerance symptoms in the last 7 days.I am willing to attend all study visits and complete all required procedures.I don't have any conditions that could confuse my dairy intolerance symptoms.I have had surgery that changed how my stomach or intestines work, except for simple surgeries like appendix removal over a year ago.I have active ulcers or a history of severe ulcers.You have had problems with drinking alcohol or using drugs in the past year.I have not taken antibiotics in the last 30 days.I am between 18 and 65 years old.You are allergic to milk.I regularly use antacids or proton pump inhibitors.I have diabetes (type 1 or type 2).I agree not to use any treatments or products for dairy intolerance during the study.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.