Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000285459
Ethics application status
Approved
Date submitted
20/02/2025
Date registered
14/04/2025
Date last updated
14/04/2025
Date data sharing statement initially provided
14/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The A1 Protein Free Vs Conventional milk study in lactose tolerant and lactose intolerant consumers
Scientific title
A randomised, controlled, double-blind, crossover pilot study investigating the metabolism of lactose following consumption of A1 and A2 beta casein milk proteins in lactose tolerant and lactose intolerant consumers
Secondary ID [1] 313910 0
None
Universal Trial Number (UTN)
U1111-1318-7792
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lactose intolerance 336601 0
Condition category
Condition code
Diet and Nutrition 333107 333107 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 333108 333108 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single oral dose (300mL) of A1 Protein Free milk taken under fasted conditions (only water for 10 hours) at the MRINZ clinical room following a 7 day washout of dairy products. The dosing is to be witnessed by an investigator, the whole dose must consumed in under 5 minutes. There is a 7 day washout between crossover doses.
Intervention code [1] 330502 0
Treatment: Other
Comparator / control treatment
A single oral dose (300mL) of Conventional milk containing A1 beta casein protein, taken under fasted conditions at the MRINZ clinical room and following a 7 day washout of dairy products. The dosing is to be witnessed by an investigator, the whole dose must consumed in under 5 minutes.

The comparator/control treatment (300 mL of Conventional milk) will also be administered at screening as a 'milk challenge'; this use is not a true 'intervention' in the study, it is used as a screening tool to assess the participant's tolerance (or intolerance) to lactose, grouping them based on their Global Symptom Score. The milk challenge will be administered under the same conditions as study interventions with the exception that participant's are not required to wash out dairy products prior to it's administration, additionally participants will be able to return home immediately following the challenge.
Control group
Active

Outcomes
Primary outcome [1] 340670 0
To describe the pharmacokinetics (PK) of lactose consumed in a single oral dose of A1PF milk (A1PF) and conventional A1/A2 beta casein containing milk (“Con” milk) in lactose tolerant and lactose intolerant healthy adults.
Timepoint [1] 340670 0
Blood and urine PK samples will be collected following administration of a single oral dose of A1PF milk and Con milk. Blood for PK analysis will be collected at the following timepoints: baseline, 10 minutes post dose, 20 minutes, 30 minutes, 45 minutes, 1 hour , 2 hours, 4 hours, 8 hours, and 24 hours post dose. Urine for PK analysis will be collected at: baseline, 0-4 hours (pooled), 4-8 hours (pooled), and at 24 hours.
Primary outcome [2] 340677 0
To describe the pharmacodynamic effects (PD) of lactose consumed in a single oral dose of A1PF milk and conventional A1/A2 beta casein containing milk (“Con”) in lactose tolerant and lactose intolerant healthy adults
Timepoint [2] 340677 0
Fecal samples will be collected at baseline and 24-48 hours following each dose, blood samples will be collected at baseline, 10, 20, 30, 45, 60, 120, 240, 480 (minutes) and 24 hours post dose.
Secondary outcome [1] 444758 0
To describe symptoms of lactose intolerance following consumption of a single oral dose of A1PF and Con milk in lactose tolerant and lactose intolerant health adults.
Timepoint [1] 444758 0
GSS will be administered to the participant at 10, 20, 30, 45, 60, 120, 240, 480 (minutes) and 24 hours post dose. Bristol Stool scale will be administered with the baseline stool sample and at the 24-48 hour post dose sample.
Secondary outcome [2] 444821 0
To explore the validity of self-reported lactose intolerance and GSS determined lactose intolerance.
Timepoint [2] 444821 0
Participants will complete the GSS for assessment of this outcome following the milk challenge at the screening visit.

Eligibility
Key inclusion criteria
1. Willing and able to provide signed informed consent and comply with all study requirements and restrictions as per the study protocol and informed consent form.
2. Adults between 18 and 65 years of age, inclusive, at the time of signing informed consent.
3. Following milk challenge total Global Symptom Score (GSS) of: Cohort 1: GSS less than or equal to 7 (lactose tolerant); Cohort 2: GSS greater than 7 (lactose intolerant)
4. Participant is in good health as determined by the investigator based on medical history, and from the absence of clinically significant abnormalities in the complete physical exam, vital signs, and laboratory tests (bloods and urine) at screening.
5. Body weight greater than or equal to 50 kg and body mass index (BMI) within the range 18.0 and 32.0 kg/m2, inclusive at screening.
6. Individuals sexually active and of child bearing potential must return a negative urine pregnancy test at screening and be willing to adhere to the contraceptive requirements of the study.
7. The participant is willing to allow their General Practitioner (GP) or usual healthcare provider to be contacted if required (for reporting of abnormal results).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Medical Conditions
1. Individual who is pregnant or planning to become pregnant during the duration of the study.
2. Any known or suspected contraindications to A1PF milk or Con milk including allergy to cow’s milk or other related conditions (with the exception of lactose intolerance for Cohort 2).
3. Individual self-reports as likely to vomit if they drink approximately 300ml (a glass) of milk. Or reports vomiting following milk challenge at screening.
4. Any known or suspected contraindications to blood draws, or is unable to provide a blood sample without significant distress, or has poor peripheral venous access and is unsuitable for cannulation/repeated venipuncture.
5. Participant has history or evidence of any clinically significant gastrointestinal condition, including oesophageal reflux, peptic ulcer disease, erosive oesophagitis, frequent (more than once per week) occurrence of heartburn, galactosemia, gastroparesis, amyloidosis, inflammatory bowel disease, malnutrition, gastric ulcers, chronic constipation, celiac disease, gastro-oesophageal reflux disease, or any other related condition that in the opinion of thenvestigator or Medical Monitor might obfuscate the study data (e.g., neuromuscular diseases,
or diseases effecting gastric motility).
6. Participant has a documented medical history of human immunodeficiency virus (HIV), acute
or chronic hepatitis B or acute or chronic hepatitis C (RNA positive), or a positive test for these at screening.
7. Participant has concurrent symptoms that may confound AE collection or assessment of symptoms of dairy intolerance: including diarrhoea, abnormal gas, bloating, cramps, or stomach pain.
Prior/Concomitant Therapy
8. Participant has history of medical interventions associated with altered GI function including: bariatric surgery, gastric bypass, or gastrointestinal endoscopy (within last 6 weeks), or any other related surgical intervention that in the opinion of the Investigator or Medical Monitor might obfuscate study data.
9. Participant is concurrently using or recently used (within 14 days of Day 1; 30 days for antibiotics) medications that may confound AE collection or assessment of symptoms of dairy intolerance, including: laxatives, stool softeners, antacids, lactase medications (or lactase fortified foods).
10. Participant is concurrently using or recently used (within 14 days of Day 1) any prescription drugs, vaccinations, vitamins or supplements unless in the opinion of the Investigator or Medical Monitor, they will not interfere with the study data or procedures.
Prior/Concurrent Clinical Study Experience
11. Participant has participated in any interventional clinical study or had been treated with any investigational drugs within 28 days or 5 half-lives, whichever was longer.
Diagnostic Assessments
12. Abnormal and clinically significant vital signs, after 5 minutes supine rest, with normal ranges as defined by: Systolic Blood Pressure (BP) 140 mmHg; Diastolic BP 90 mmHg; heart rate 85 beats per minute (BPM); tympanic body temperature 37.7; respiratory rate 25. Abnormal values may be repeated once at the discretion of the Investigator.
13. Positive screen for drugs of abuse, or alcohol at the Screening Visit.
14. A positive test for human immunodeficiency virus (HIV), hepatitis B or hepatitis C (RNA positive), at screening.
15. Any abnormal and clinically significant results from screening blood tests (normal/abnormal defined by local laboratory reference values)
Other Exclusions
16. Participant has consumed milk-containing products within 7 days prior to Day 1 (and until completion of the final follow-up on Day 12). Participant must abstain from dairy (animal) milk- containing foods such as: fresh milk, UHT milk, powdered milk, condensed milk, cheese, cream, yogurt, whey protein, milky coffee and tea, ice cream, butter, ghee, and other related products prepared with milk/dairy products.
17. Participant has any dietary restrictions or preferences that may interfere with them taking part in the study including being vegan or being unwilling to abstain from consumption of milk products for the length of the study.
18. Participant is unwilling to abstain from alcohol for 48 hours prior to dosing and for the 24 hours prior to screening.
19. Participant has donated blood in the 3 months prior to Day 1 or Day 8, or plasma in the two weeks prior to screening, Day 1 or Day 8.
20. Participant has any planned surgery during the study duration.
21. Participant is an employee, consultant, and/or immediate family member (ie, first degree
relative, spouse, adoptees, or legal dependents) of the site or Sponsor.
22. Any other condition which, at the Investigator’s discretion, is believed may present a safety risk
or impact the feasibility of the study or the study results.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation via computer, concealed from blinded investigators by limiting rights.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/05/2025
Actual
Date of last participant enrolment
Anticipated
19/11/2025
Actual
Date of last data collection
Anticipated
12/12/2025
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 26870 0
New Zealand
State/province [1] 26870 0

Funding & Sponsors
Funding source category [1] 318383 0
Commercial sector/Industry
Name [1] 318383 0
The a2 Milk Company
Country [1] 318383 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
The a2 Milk Company
Address
Country
New Zealand
Secondary sponsor category [1] 320829 0
None
Name [1] 320829 0
Address [1] 320829 0
Country [1] 320829 0
Other collaborator category [1] 283420 0
Other
Name [1] 283420 0
The Medical Research Institute of New Zealand
Address [1] 283420 0
Country [1] 283420 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317016 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 317016 0
Ethics committee country [1] 317016 0
New Zealand
Date submitted for ethics approval [1] 317016 0
20/12/2024
Approval date [1] 317016 0
17/01/2025
Ethics approval number [1] 317016 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139742 0
Mr Alex Martin
Address 139742 0
Medical Research Institute of New Zealand, Level 7, CSB Building, Wellington Regional Hospital, Riddiford Street, Newtown 6021, Wellington
Country 139742 0
New Zealand
Phone 139742 0
+64 4 805 0264
Fax 139742 0
Email 139742 0
[email protected]
Contact person for public queries
Name 139743 0
Alex Martin
Address 139743 0
Medical Research Institute of New Zealand, Level 7, CSB Building, Wellington Regional Hospital, Riddiford Street, Newtown 6021, Wellington
Country 139743 0
New Zealand
Phone 139743 0
+64 4 805 0264
Fax 139743 0
Email 139743 0
[email protected]
Contact person for scientific queries
Name 139744 0
Alex Martin
Address 139744 0
Medical Research Institute of New Zealand, Level 7, CSB Building, Wellington Regional Hospital, Riddiford Street, Newtown 6021, Wellington
Country 139744 0
New Zealand
Phone 139744 0
+64 4 805 0264
Fax 139744 0
Email 139744 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.