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NCT03713346
Comparing the Digestion of Milk With Different Beta-casein Protein Content by Dairy Intolerant Persons
NA trial testing Lactose free milk in Dairy Intolerance in 42 participants. Completed in 3 September 2021.
3 September 2021
Quick facts
| Lead sponsor | Purdue University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | other |
| Enrollment | 42 |
| Start date | 17 January 2018 |
| Primary completion | 3 September 2021 |
| Estimated completion | 3 September 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Lactose free milk
- Jersey milk
- High A1 β-casein milk
- High A2 β-casein milk
Conditions studied
- Dairy Intolerance — all drugs for Dairy Intolerance →
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):
-
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
Verify or expand the search:
- PubMed search for NCT03713346
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03713346 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Purdue University
- Last refreshed: 8 October 2021
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/NCT03713346.
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