Comparing the Digestion of Milk With Different Beta-casein Protein Content by Dairy Intolerant Persons

Recruiting in Palo Alto (17 mi)

Overseen by Dennis A Savaiano, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Purdue University

No Placebo Group

Trial Summary

What is the purpose of this trial?

Persons with dairy intolerance may experience cramps/abdominal pain, bloating, flatulence, acute diarrhea, or fecal urgency when they ingest excessive amounts of lactose. The intensity of these conditions can be mild or severe and likely depends on numerous variables including dose, transit time, intestinal residual lactase activity and microbiome potential to ferment lactose. Jersey cattle produce milk containing high levels of the A2 β-casein protein . There are claims that high A2 β-casein milk is more easily digested by people who are lactose maldigesters . We propose to conduct a double-blinded, randomized, controlled trial to determine if high A2 β-casein milk from Jersey cattle is actually better digested and tolerated by lactose maldigesters.

Research Team

Dennis A Savaiano, PhD

Principal Investigator

Purdue University

Eligibility Criteria

Inclusion Criteria

Ability/desire to provide informed consent

Aged 18 to 65 years of age inclusive at screening

Current or recent history of intolerance to and avoidance of milk of at least one month duration (by self-report and self-reported symptoms).

Treatment Details

Interventions

• High A1 β-casein milk (Protein)
• High A2 β-casein milk (Protein)
• Jersey milk (Protein)
• Lactose free milk (Behavioural Intervention)

Participant Groups

Group I: Lactose maldigester Experimental Treatment 4 Interventions

Group II: Lactose digester Experimental Treatment 4 Interventions

Who Is Running the Clinical Trial?

Purdue University

Lead Sponsor

Trials

239

Recruited

72,200+

Mitchell E. Daniels, Jr.

Purdue University

Chief Executive Officer since 2013

BS in Chemical Engineering from Purdue University

Dr. Elizabeth Topp

Purdue University

Chief Medical Officer since 2020

MD from Harvard Medical School