Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000127808
Ethics application status
Approved
Date submitted
2/12/2020
Date registered
8/02/2021
Date last updated
28/07/2023
Date data sharing statement initially provided
8/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Amino acid uptake from different milk drinks: an acute study.
Scientific title
Amino acid appearance from dairy- based protein based drinks in healthy adults..
Secondary ID [1] 302930 0
Nil
Universal Trial Number (UTN)
Trial acronym
Amino
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early sarcopenia. 319948 0
Condition category
Condition code
Diet and Nutrition 317883 317883 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 318185 318185 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will arrive at the provider’s laboratory, after an overnight fast. Following insertion of an intravenous catheter, an initial blood sample will be taken into heparin-treated BD Vacutainers as well as gold top vacutainers for serum. Prior to consumption, 1000 mg paracetamol will be added to all of four beverages to be consumed ( in randomised order) and the beverage thoroughly mixed. The subjects will then consume the assigned beverage (within 5 min) in front of the research technician. Seven further blood samples will be taken over 4 hours at times +15, +30, +60, +90, +120, +180, and +240 following baseline. Samples will be separated by centrifugation for 15 minutes (within 15 minutes of collection). Serum and plasma will be aliquoted and stored at -80 degrees till analysed. Participants present on four separate occasions in total and two intervention products and two competitor products will be tested, each one week apart. Beverages include: Dairy milk UHT beverage containing 10% protein, Dairy milk UHT beverage containing 10% protein, competitor Dairy milk UHT containing 10% protein, competitor Dairy milk UHT containing 14% protein.
Intervention code [1] 319214 0
Lifestyle
Intervention code [2] 319215 0
Treatment: Other
Intervention code [3] 319445 0
Prevention
Comparator / control treatment
Comparator: UHT dairy beverage containing 10% protein and UHT dairy beverage containing 14% protein.
Subjects will arrive at the provider’s laboratory, after an overnight fast. Following insertion of an intravenous catheter, an initial blood sample will be taken into heparin-treated BD Vacutainers as well as gold top vacutainers for serum. Prior to consumption, 1000 mg paracetamol will be added to all beverages to be consumed in the current session and the beverage thoroughly mixed. The subjects will then consume the assigned beverage (within 5 min) in front of the research technician. Seven further blood samples will be taken over 4 hours. Participants present on four separate occasions in total and two intervention products and two competitor products will be tested, each one week apart.
Control group
Active

Outcomes
Primary outcome [1] 325901 0
Amino Acid concentrations in serial blood samples collected over four hours.
Timepoint [1] 325901 0
Mean area under the curve (AUC 0-240) and 0, +15,+30, +60, +90, +120, +180, +240 min (primary timepoint) post-consumption of beverage..
Primary outcome [2] 325902 0
Blood glucose concentrations in serial blood samples collected over 4 hours.
Timepoint [2] 325902 0
0, +240 min: Mean area under the curve (AUC 0-240) and 0, +15,+30, +60, +90, +120, +180, +240 min (primary endpoint) post-consumption of beverage
Primary outcome [3] 325903 0
Blood insulin levels as measured by blood sample.
Timepoint [3] 325903 0
0, +240 min. Mean area under the curve (AUC 0-240) and 0, +15,+30, +60, +90, +120, +180, +240 min(primary endpoint) post-consumption of beverage.
Secondary outcome [1] 389468 0
Level of paracetamol uptake as measured by blood sample,
Timepoint [1] 389468 0
Mean area under the curve (AUC 0-240) and 0, +15,+30, +60, +90, +120, +180, +240 min post-consumption of beverage.

Eligibility
Key inclusion criteria
BMI below 35; Non-smoker;
Minimum age
40 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diagnosed with cancer, vascular disease or diabetes; having any GIT diseases; kidney or liver impairment; recent major surgery and sensitive to dairy products; vegetarian; sensitive to paracetamol; taking anticoagulants; exceeding moderate alcohol intake; endocrine disease; allergic to plasters.

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)
Allocation is not concealed
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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Bio-availability
Statistical methods / analysis
One-way ANOVA
a: less than or equal to 0.05 Assumed standard deviation = 71 Factors: 1 Number of levels: 4
Maximum Sample Target
Difference Size Power Actual Power
82 18 0.8 0.816655
The sample size is for each level.
Outcome variables (area under the curve (AUC), raw data and difference from baseline) will be analysed using linear mixed model ANOVA.
For the repeated measures analysis, subject, treatment, visit and time will be included in the procedure, in addition to the treatment-by-time interaction, which addresses whether the trajectory over time during the visit differed between treatments. The model for difference from baseline will include the result at baseline as a covariate.
Where the linear mixed model ANOVA results are significant, Tukey’s post hoc analysis will be used for comparisons between treatments. Statistical significance will be set at a level of 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/11/2019
Date of last participant enrolment
Anticipated
31/03/2021
Actual
25/05/2021
Date of last data collection
Anticipated
31/05/2021
Actual
30/06/2022
Sample size
Target
20
Accrual to date
Final
18
Recruitment outside Australia
Country [1] 23239 0
New Zealand
State/province [1] 23239 0
Manawatu

Funding & Sponsors
Funding source category [1] 307351 0
Commercial sector/Industry
Name [1] 307351 0
Fonterra Cooperative Group Ltd
Country [1] 307351 0
New Zealand
Primary sponsor type
University
Name
Massey University, Palmerston North
Address
School of Health Sciences, College of Health, Massey University, Private Bag 11222, Palmerston North, Manawatu-Wanganui, 4442.
Country
New Zealand
Secondary sponsor category [1] 307990 0
None
Name [1] 307990 0
Address [1] 307990 0
Country [1] 307990 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307438 0
Massey University Southern A Human Ethics Committee
Ethics committee address [1] 307438 0
Ethics committee country [1] 307438 0
New Zealand
Date submitted for ethics approval [1] 307438 0
19/08/2019
Approval date [1] 307438 0
27/09/2019
Ethics approval number [1] 307438 0
SOA 19-55

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

Contacts
Principal investigator
Name 107238 0
Prof Marlena Kruger
Address 107238 0
School of Health Sciences, College of Health, Massey University, Private Bag 11222, Palmerston North, Manawatu-Wanganui, 4442
Country 107238 0
New Zealand
Phone 107238 0
+6421476891
Fax 107238 0
Email 107238 0
[email protected]
Contact person for public queries
Name 107239 0
Marlena Kruger
Address 107239 0
School of Health Sciences, College of Health, Massey University, Private Bag 11222, Palmerston North, Manawatu-Wanganui, 4442
Country 107239 0
New Zealand
Phone 107239 0
+6421476891
Fax 107239 0
Email 107239 0
[email protected]
Contact person for scientific queries
Name 107240 0
Marlena Kruger
Address 107240 0
School of Health Sciences, College of Health, Massey University, Private Bag 11222, Palmerston North, Manawatu-Wanganui, 4442.
Country 107240 0
New Zealand
Phone 107240 0
+6421476891
Fax 107240 0
Email 107240 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Commercially senstive


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
SourceTitleYear of PublicationDOI
EmbaseIncreased Post-Prandial Plasma Amino Acid Peak Following Compact Ons Consumption With Functional Dairy Proteins.2023https://dx.doi.org/10.1016/j.clnesp.2022.09.464
N.B. These documents automatically identified may not have been verified by the study sponsor.