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Dairy Product
A2 vs Regular 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
Agrees to refrain from all other treatments and products used for dairy intolerance (e.g., Lactaid® Dietary Supplements) during study involvement
Aged 18 to 65 years of age inclusive at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 to day 14 after 500 ml milk consumption and within the 6 hours following milk dose on day 15
Awards & highlights
Study Summary
This trial shows that milk with A1 protein leads to more symptoms of lactose intolerance & inflammation than milk with A2.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include typical symptoms of lactose intolerance such as gas, bloating, diarrhea, cramps or stomach pain due to consumption of milk containing A1 beta-casein.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree not to use any products for dairy intolerance during the study.
Select...
I am between 18 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from day 1 to day 14 after 500 ml milk consumption and within the 6 hours following milk dose on day 15
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 to day 14 after 500 ml milk consumption and within the 6 hours following milk dose on day 15
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Difference in hydrogen between commercial and A2 milk
Difference in inflammation between commercial and A2 milk
Difference in symptoms between commercial and A2 milk
Trial Design
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
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Who is running the clinical trial?
Purdue UniversityLead Sponsor
224 Previous Clinical Trials
72,729 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:- 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.I do not have HIV, Hepatitis B, or Hepatitis C.You have avoided or had problems with dairy products for at least one month.You have had issues with drinking alcohol or using drugs in the last year.I agree not to use any products for dairy intolerance during the study.I am willing to attend all study visits and complete all required procedures.I have a history of digestive system diseases that could affect study results.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 not taken antibiotics in the last 30 days.I haven't used products for dairy intolerance in the last 7 days.I have a condition like Parkinson's or gastroparesis affecting my stomach's movement.I regularly use antacids or proton pump inhibitors.I have been diagnosed with congestive heart failure.I have had a high colonic enema in the last 30 days.I have active ulcers or a history of severe ulcers.I am between 18 and 65 years old.I have diabetes (type 1 or type 2).You are allergic to milk.I am currently receiving chemotherapy.You weigh less than 16.5 kilograms or have a BMI over 35 kilograms per square meter.
Research Study Groups:
This trial has the following groups:- Group 1: Old World milk
- Group 2: New World milk
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the age cap for this research extend beyond 25 years of age?
"As outlined in the eligibility requirements, the minimum age to partcipate is 18 and no older than 65."
Answered by AI
What qualifications are necessary to be an eligible participant in this research?
"This trial is seeking 35 individuals aged 18-65 with lactose intolerance. To qualify, candidates must present a current or recent aversion to dairy products that has lasted for at least one month as evidenced by self-reported symptoms and experiences."
Answered by AI
How many participants are involved in this trial?
"Indeed, the research being conducted is actively looking for participants. The trial that was initially posted on December 2nd 2021 has seen its most recent update happen as recently as March 27th 2023. 35 individuals from a single site are needed to join this experiment."
Answered by AI
Are there any vacancies for participants in this medical trial?
"Clinicaltrials.gov reveals that this trial is still open for recruitment, with the first advertisement posted on December 2nd 2021 and the most recent edit made March 27th 2023."
Answered by AI
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