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NCT03713346

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

Completed NA Last updated 8 October 2021
What this trial tests

NA trial testing Lactose free milk in Dairy Intolerance in 42 participants. Completed in 3 September 2021.

Timeline
17 January 2018
Primary endpoint
3 September 2021
3 September 2021

Quick facts

Lead sponsorPurdue University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposeother
Enrollment42
Start date17 January 2018
Primary completion3 September 2021
Estimated completion3 September 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Purdue University

Who can join

Adults 18 to 65, any sex, with Dairy Intolerance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. 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.
    Ramakrishnan M, Eaton TK, Sermet OM, Savaiano DA. · · 2020 · cited 34× · PMID 33348621 · DOI 10.3390/nu12123855

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