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NCT03713346 · ClinicalTrials.gov registry record · NA

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

A NA study of Dairy Intolerance, sponsored by Purdue University.

Completed
Registry status
NA
Development phase
42
Enrollment target
1
Study location

NCT03713346: Completed NA study of Dairy Intolerance, sponsored by Purdue University.

NCT03713346 is a NA study of Dairy Intolerance that has completed, run by Purdue University. The registered enrollment target is 42 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03713346, a NA study of Dairy Intolerance, has completed, sponsored by Purdue University.

COMPLETED
Registry status
NA
Development phase
42 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

Differences in AUC ΔH2 concentrations (primary outcomes) among milk phases is examined by repeated-measures analysis of variance (ANOVA)

Conditions Studied

Interventions

  • OTHER Lactose free milk
  • OTHER Jersey milk
  • OTHER High A1 β-casein milk
  • OTHER High A2 β-casein milk

Study Locations (1)

Indiana

  • Purdue University - West Lafayette

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2018-01-17
Est. Completion 2021-09-03
Phase NA
Purdue University

141 total trials

What the finished NCT03713346 record still lists

NCT03713346 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 1 condition, with Dairy Intolerance appearing as the primary indexed condition, and to 4 interventions - of which Lactose free milk is the first listed.

NCT03713346 reports a single indexed study location in Indiana.

Frequently Asked Questions

What is clinical trial NCT03713346 about?

NCT03713346 is a clinical study titled "Comparing the Digestion of Milk With Different Beta-casein Protein Content by Dairy Intolerant Persons". 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, in...

What is the current status of trial NCT03713346?

This trial is currently completed. It is a NA study. The enrollment target is 42 participants. The study started on 2018-01-17. Estimated completion is 2021-09-03.

What conditions does trial NCT03713346 study?

This clinical trial studies the following conditions: Dairy Intolerance.

What interventions are being tested in trial NCT03713346?

The interventions under investigation include: Lactose free milk (OTHER), Jersey milk (OTHER), High A1 β-casein milk (OTHER), High A2 β-casein milk (OTHER).

Who is sponsoring clinical trial NCT03713346?

This trial is sponsored by Purdue University, which has 141 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03713346 being conducted?

This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT03713346's enrollment target sits among peer trials

42 1436th of 2000 higher than 555 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03713346, the US trial registry maintained by the National Library of Medicine. NCT03713346 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.