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NCT06763185 · ClinicalTrials.gov registry record · NA
A1 Beta-casein-free Milk in Milk-intolerant Participants
A NA study of Digestive Discomfort, sponsored by a2 Milk Company.
- Completed
- Registry status
- NA
- Development phase
- 54
- Enrollment target
- 1
- Study location
NCT06763185 is a NA study of Digestive Discomfort that has completed, run by a2 Milk Company. The registered enrollment target is 54 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06763185, a NA study of Digestive Discomfort, has completed, sponsored by a2 Milk Company.
- COMPLETED
- Registry status
- NA
- Development phase
- 54 participants
- Enrollment target
- 1
- Study location
Study Summary
This was a single-site, double-blind, randomised, controlled, crossover study, which aimed to compare the effects of conventional cow's milk (CON, containing both A1- and A2-types of beta-casein) versus milk free of A1-type beta-casein (A1PF milk) on gastrointestinal (GI) physiology and symptoms of digestive discomfort in non-regular milk drinkers with self-reported intolerance to conventional cow's milk. The study location was the Pennington Biomedical Research Center in Louisiana, USA. The study comprised a 2-week washout period, 2 weeks of milk consumption, crossover, a second 2-week washout period, and a second 2-week period of milk consumption. Eligible participants were stratified by sex to achieve an approximate 1:1 male to female ratio and were randomised to receive conventional cow's milk (sequence 1) or A1PF milk (sequence 2) during the first period of milk consumption. During the second period of milk consumption, participant groups underwent crossover to receive the alternate study milk. Milk was consumed three times per day after meals, with 250 mL provided at each administration. During washout periods, participants were required to avoid all dairy products and use only rice milk to replace any normal dairy intake, and to avoid foods with very high fermentable oligosaccharides, disaccharides, monosaccharides, and polyols content, to avoid potential confounding of the symptoms experienced. Any medication, nutritional supplements, dairy products, acidophilus milk, or probiotics were prohibited during the study. The study protocol and all related documentation were approved by the Pennington Biomedical Research Center Institution Review Board. The study was conducted in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice Guidelines of the International Conference on Harmonisation. All participants provided written informed consent prior to initiating any study procedures.
Conditions Studied
Interventions
- OTHER Dietary Supplement: conventional cow's milk consumption, and then A1PF milk consumption
- OTHER Dietary Supplement: A1PF milk consumption, and then conventional cow's milk consumption
Study Locations (1)
Louisiana
- Pennington Biomedical Research Center - Baton Rouge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2017-04-28 |
| Est. Completion | 2019-03-27 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06763185
The ClinicalTrials.gov registry entry for NCT06763185 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is a2 Milk Company, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Digestive Discomfort appearing as the primary indexed condition, and to 2 interventions - of which Dietary Supplement: conventional cow's milk consumption, and then A1PF milk consumption is the first listed.
NCT06763185 reports 1 study location spanning 1 distinct geographic area - top geographies include Louisiana.
Frequently Asked Questions
What is clinical trial NCT06763185 about?
NCT06763185 is a clinical study titled "A1 Beta-casein-free Milk in Milk-intolerant Participants". This was a single-site, double-blind, randomised, controlled, crossover study, which aimed to compare the effects of conventional cow's milk (CON, containing both A1- and A2-types of beta-casein) versus milk free of A1-type beta-casein (A1PF milk) on gastrointestinal (GI) physiology and symptoms of ...
What is the current status of trial NCT06763185?
This trial is currently completed. It is a NA study. The enrollment target is 54 participants. The study started on 2017-04-28. Estimated completion is 2019-03-27.
What conditions does trial NCT06763185 study?
This clinical trial studies the following conditions: Digestive Discomfort.
What interventions are being tested in trial NCT06763185?
The interventions under investigation include: Dietary Supplement: conventional cow's milk consumption, and then A1PF milk consumption (OTHER), Dietary Supplement: A1PF milk consumption, and then conventional cow's milk consumption (OTHER).
Who is sponsoring clinical trial NCT06763185?
This trial is sponsored by a2 Milk Company, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06763185 being conducted?
This trial has 1 study location across Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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