Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001300662p
Ethics application status
Submitted, not yet approved
Date submitted
8/11/2023
Date registered
13/12/2023
Date last updated
13/12/2023
Date data sharing statement initially provided
13/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Dose response of alpha lactalbumin supplementation on serum Tryptophan (TRP):Large Neutral Amino Acid (LNAA) ratio.
Scientific title
Dose response of alpha lactalbumin supplementation on serum TRP:LNAA ratio in active population.
Secondary ID [1] 310903 0
Nil known
Universal Trial Number (UTN)
U1111-1299-9403
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Serum tryptophan (TRP): Large Neutral Amino Acids (LNAA) ratio 331959 0
Condition category
Condition code
Other 329051 329051 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study Design -Through a randomised, double blinded, crossover design, each participant will receive all four dosages (10,20,30,40g) of the experimental BiPRO Alpha 9000 (Agropur Inc, Appleton, WI) alpha-lactalbumin (ALAC) supplement powder, in the form of a beverage (mixed with water and non-caloric sweetener), on four different occasions, separated by a washout period. The different ALAC supplement doses will be matched for taste and provided to participants by an external researcher, to ensure both participants and the researcher team remain blind to the treatments.
The participant will be supervised by the student researcher to ensure they complete consumption of the beverage within 10 minutes of receiving it.

Washout -The wash-out phase is defined as a period of minimum three days to limit any carry-over effect of the ALAC supplement on the serum Tryptophan:LNAA ratio before administering the next dose. This ensures that the experimental protein dosages are adequately separated. During the wash-out period, the participants will be required to continue eating and training as per their usual routine. No supplement will be provided during this phase.

As is the nature of a crossover trial, each participant will serve as their own control.

Intervention code [1] 327326 0
Treatment: Other
Comparator / control treatment
Baseline TRP:LNAA ratio and plasma melatonin levels will serve as control.
Control group
Dose comparison

Outcomes
Primary outcome [1] 336519 0
Biochemical Measures (Plasma Amino Acids analysis)
Changes in the blood plasma tryptophan (TRP): large neutral amino acid (LNAA) ratio.
Timepoint [1] 336519 0
During each intervention session i.e. each of the four ALAC doses, blood samples will be collected via cannulation.
Five blood samples will be collected including pre-supplement consumption, 90 mins, 120 mins, 180 mins and 210 mins post supplement consumption. Changes in the blood plasma TRP:LNAA ratio will be analysed at each of these five timepoints, across all four intervention sessions.
Secondary outcome [1] 428680 0
Biochemical measures (Plasma Melatonin)
Changes in plasma melatonin levels.
Timepoint [1] 428680 0
During each intervention session i.e. each of the four ALAC doses, two saliva samples will be collected including immediately pre-supplement consumption and 210 mins post supplement consumption.
Secondary outcome [2] 428681 0
Palatability of the different supplement doses
Timepoint [2] 428681 0
During each intervention session i.e. each of the four ALAC doses, the VAS -GI symptoms questionnaire will be administered before the supplement consumption (baseline) and at 120 mins post supplement consumption.
Secondary outcome [3] 429327 0
Preference of the different supplement doses
Timepoint [3] 429327 0
During each intervention session i.e. each of the four ALAC doses, the VAS-sensory evaluation questionnaire will be administered immediately post consumption of the supplement, in order to gauge the preference of the different doses of the supplement.

Eligibility
Key inclusion criteria
Participants must be aged 18-35yrs, recreationally active i.e. completing at least 150 to 300 min moderate-intensity activity or 75–150 min of vigorous-intensity activity a week, plus muscle-strengthening activities 2 or more days a week.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants must not be facing any existing sleeping disorders such as insomnia or consuming any nutraceutical or herbal sleeping aids such as melatonin gummies, chamomile or other herbs which could influence exogenous melatonin production.
Participants will be screened using the Pittsburgh Scale Quality Index (PSQI) questionnaire and a score of >5 will be excluded from the trial.
Excessive beer or wine consumption (>17 standard drinks per week), dairy allergy, high caffeine use (e.g., >5 mg·kg-1·d-1), antidepressant or sleep medication use, current or recently finished night shift work, recent transmeridian travel, fluctuating bedtimes, and pregnancy are also exclusions from this trial due to confounding influences that may have on the circadian rhythm, exogenous melatonin production or the plasma TRP:LNAA ratio.

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)
Randomisation will be at the level of the individual participant (ID) using a computer-generated random number sequence by an independent external researcher not involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned a computer -generated random number sequence in a latin square design.
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
Efficacy
Statistical methods / analysis
Statistical power calculation - A paired t-test achieves 85% power to infer that effect size is above the mean difference of 0.5. When the total sample size of a cross-over design is 16, the actual mean difference is 0.024, the square root of the within mean square error is 0.05, and the significance level further adjusted from 0.05 to 0.01 to account for repeated comparisons within the group.

Statistical analysis - Initially, data cleaning will be performed to identify missing and corrupt data. Data will be analysed using generalised linear mixed models within StataIC 16 (StataCorp LLC, TX, USA).
The effect of dietary intervention (dose response effect of a-lactalbumin) and time period (i.e., sequence receiving condition) and their interaction, will be fitted as fixed effects to determine whether there was a difference in the effect of dietary intervention over period on dependant variables of amino acid analysis and plasma melatonin. Participant identification number will be used as a random factor to account for repeated measures in each model.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2024
Actual
Date of last participant enrolment
Anticipated
6/02/2026
Actual
Date of last data collection
Anticipated
20/02/2026
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315159 0
Commercial sector/Industry
Name [1] 315159 0
Agropur US
Country [1] 315159 0
United States of America
Primary sponsor type
University
Name
Deakin University -Centre for Sports Research
Address
221 Burwood Highway, Burwood, Victoria 3125
Country
Australia
Secondary sponsor category [1] 317198 0
None
Name [1] 317198 0
Address [1] 317198 0
Country [1] 317198 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314096 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 314096 0
Ethics committee country [1] 314096 0
Australia
Date submitted for ethics approval [1] 314096 0
10/11/2023
Approval date [1] 314096 0
Ethics approval number [1] 314096 0

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

Contacts
Principal investigator
Name 130394 0
Dr Dominique Condo
Address 130394 0
Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 130394 0
Australia
Phone 130394 0
+61 3 924 45487
Fax 130394 0
Email 130394 0
[email protected]
Contact person for public queries
Name 130395 0
Dominique Condo
Address 130395 0
Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 130395 0
Australia
Phone 130395 0
+61 3 924 45487
Fax 130395 0
Email 130395 0
[email protected]
Contact person for scientific queries
Name 130396 0
Dominique Condo
Address 130396 0
Deakin University, 221 Burwood Hwy, Burwood VIC 3125
Country 130396 0
Australia
Phone 130396 0
+61 3 924 45487
Fax 130396 0
Email 130396 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices).
When will data be available (start and end dates)?
Immediately following publication to 5 years following publication.
Available to whom?
Researchers who provide a methodologically sound proposal.
Available for what types of analyses?
To achieve aims in the approved proposal.
How or where can data be obtained?
Proposals should be directed to [email protected]. To gain access, data requesters will need to sign a data access agreement.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20846Study protocol    File attached 386834-(Uploaded-27-11-2023-16-30-09)-Study-related document.pdf
20847Informed consent form    File attached 386834-(Uploaded-27-11-2023-16-35-37)-Study-related document.pdf



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.