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NCT05658861

Comparing the Gastric Transit of Commercial Milk and A2 Milk

Completed NA Last updated 21 November 2023
What this trial tests

NA trial testing Milk containing A1 and A2 beta-casein in Lactose Intolerance, Adult Type in 10 participants. Completed in 1 December 2022.

Timeline
21 June 2021
Primary endpoint
6 October 2022
1 December 2022

Quick facts

Lead sponsorPurdue University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingtriple
Primary purposeother
Enrollment10
Start date21 June 2021
Primary completion6 October 2022
Estimated completion1 December 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Purdue University

Who can join

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

Sponsor's own description

Cow's milk contains two types of β-casein: A1 and A2. The μ-opioid peptide BCM-7 is released from A1 but not from A2. BCM-7 is associated with slower gastrointestinal transit and hence increased gastrointestinal transit times. Lactose maldigesters reported an increase in abdominal pain due to consumption of milk containing A1 beta-casein as compared to milk containing only A2 beta-casein. The hypothesis of this study is that the differential abdominal pain is due to the differential gastric transit. This is a double-blinded, randomized, controlled trial conducted to determine if the transit of A1 β-casein milk is modified in the stomach as compared to milk with only A2 β-casein.

Publications & conference data

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

  1. Gastric Emptying of New-World Milk Containing A1 and A2 Β-Casein Is More Rapid as Compared to Milk Containing Only A2 Β-Casein in Lactose Maldigesters: A Randomized, Cross-Over Trial Using Magnetic Resonance Imaging.
    Ramakrishnan M, Zhou X, Dydak U, Savaiano DA. · · 2023 · cited 10× · PMID 36839159 · DOI 10.3390/nu15040801

Verify or expand the search:

Other trials of Milk containing A1 and A2 beta-casein

Trials testing the same drug.

Other recruiting trials for Lactose Intolerance, Adult Type

Currently open trials in the same condition.

Other Purdue University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05658861.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing