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Trial registered on ANZCTR


Registration number
ACTRN12625000073404p
Ethics application status
Not yet submitted
Date submitted
10/01/2025
Date registered
23/01/2025
Date last updated
23/01/2025
Date data sharing statement initially provided
23/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the Effects of a Different Protein Beverages on Protein Digestion and Absorption
Scientific title
Evaluating the Effects of a Whey Protein Hydrolysate and Concentrate Blend on Protein Digestion and Absorption in Older Adults
Secondary ID [1] 313675 0
None
Universal Trial Number (UTN)
U1111-1317-5378
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia 336246 0
Condition category
Condition code
Oral and Gastrointestinal 332786 332786 0 0
Normal oral and gastrointestinal development and function
Musculoskeletal 332787 332787 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will incorporate a randomised, blinded, cross-over study consisting of three experimental trial mornings at Swinburne University. Each of the experimental trial mornings (described below) will be separated (i.e., ‘wash-out’ period) by a minimum 4 days. On the experimental days, participants will be randomly allocated to consume one of three whey protein beverages:
1) 250ml of 0.4 g/kg whey hydrolysate and concentrate blend (50% volume of each 100% hydrolysate and 100% concentrate as indicated below) mixed in water.
2) 250ml of 0.4 g/kg 100% whey protein hydrolysate mixed in water (100% whey protein hydrolysate containing approximately 90% protein).
3) 250ml of 0.4 g/kg 100% whey protein concentrate mixed in water (100% whey protein concentrate containing approximately 74% protein).

The selected dose of each whey protein beverage is based on previous research demonstrating this quantity of protein to maximally stimulate muscle protein synthesis in older adults which is an amount that can practically translated into habitual lifestyles. All protein beverages will be mixed in water in the Dietetics facility at Swinburne University using commercially available protein supplement shakes. Whey protein beverages will be provided in a restricted random order based on the recruitment order to ensure that an equal number of participants receive the three intervention beverages on experimental days one, two and three, respectively. One of the primary investigators who will not take an active part in the blood sampling procedures or the following laboratory analysis (described subsequently) will perform the randomisation. Participants will be blinded to the content and order of the intervention beverages.

Participants will first undertake a preliminary visit (‘Visit 1’) to provide the research team a signed medical clearance form from their local GP, complete/sign the study consent form, undertake measurements for BMI (height and weight) as well as body composition measure on a bioelectrical impedance scale). Within the next 1-2 weeks in the lead up to an experimental trial morning (described subsequently), participants will be instructed to refrain from exercise training and vigorous physical activity and alcohol consumption for a minimum of 48 hours. Participants will also be provided with standardised prepacked meals consisting of 3 g carbohydrate g/kg body mass, 0.5 g protein g/kg body mass, and 0.3 g fat g/kg body mass in the form of Spaghetti Bolognese, jelly, muesli bar and fruit to be consumed as the final caloric intake the evening before reporting for an experimental trial. Participants will be instructed to record their dietary intake and physical activity level on the day before the first trial. These recordings will be used as a standard plan before the following trial days to ensure standardisation of dietary intake and physical activity level. To monitor adherence to the standardised diet, participants will be provided a sheet with tick boxes next to each food item to tick if they have fully consumed that food item and a notes section to write any notes if a good item has not been fully consumed.

On the morning of an experimental trial, participants will arrive to the Clinical Space in Building SPW at Swinburne University after an approximately 10-h overnight fast (nil food with ad libitum water allowed). After resting for approximately 15 min, a catheter will be inserted by a qualified phlebotomist into the antecubital vein of a preferred arm and a baseline blood sample (approximately 5 mL) will be obtained. Participants will then consume one of the three whey protein drinks outlined above. Participants will be instructed to consume the drink within 2 min (under the direct supervision of the research team) at which the time will be designated as time zero. Additional blood samples (approximately 5ml each) will be obtained at 15 min, 30 min, 45 min, 60 min, 120 min, 180 min and 240 min following beverage consumption for a total of 8 samples and 40 mL of blood. During this time, participants will remain in a resting position will be required to abstain from any food or beverages throughout the trial hours. Participants will also complete a simple Likert Scale to evaluate taste of each beverage throughout the recovery period. At the completion of the four-hour trial, participants will be provided a meal prior to departing the Swinburne campus.
Intervention code [1] 330268 0
Treatment: Other
Comparator / control treatment
There are two comparator/ control treatments:
1) 250ml of 0.4 g/kg 100% whey protein hydrolysate mixed in water on one random occasion AND
2) 250ml of 0.4 g/kg 100% whey protein concentrate mixed in water
Control group
Active

Outcomes
Primary outcome [1] 340314 0
Time to peak amino acid concentration after ingestion of the intervention beverages.
Timepoint [1] 340314 0
Pre beverage, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min and 240 min following beverage consumption.
Primary outcome [2] 340399 0
Accumulated amino acid concentration of the individual amino acids after ingestion of the intervention beverages.
Timepoint [2] 340399 0
Pre beverage, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min and 240 min following beverage consumption.
Secondary outcome [1] 443653 0
Protein beverage taste
Timepoint [1] 443653 0
Pre beverage, 60 min, 120 min, 180 min and 240 min following beverage consumption.

Eligibility
Key inclusion criteria
• Aged between 60-80 years.
• Community-dwelling (i.e.: not living in an aged-care facility, etc)
• Have a Body Mass Index (BMI) between 18.5-35
• Deemed healthy based on responses to a medical questionnaire designed specifically for this study
Minimum age
60 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(1) Being aged <60 years or >80 years of age
(2) Known dairy allergies or intolerances to lactose
(3) Any known gastrointestinal (GI) disorders or renal/kidney (acute or chronic) disease)
(4) The use of medication that could influence absorption after food intake
(5) High blood pressure/ hypertension (>140/90 mmHg)
(6) Use of supplements during the trial period
(7) Weight loss or gain of more than 2 kg during the preceding 6-weeks to the trial period (8) Inability to stand unaided, or (9) inability to commit to the study and its requirement.

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 by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Bio-availability
Statistical methods / analysis
Statistical analysis will be performed using GraphPad Prism (GraphPad Software Inc., San Diego, CA, USA). Blood sample concentrations and area under the curve (AUC) data will be analysed using a two-factor Repeated Measures ANOVA with statistical significance defined as p < 0.05. All data sets will be tested for normal distribution and sphericity prior to the ANOVA analysis using the Shapiro-Wilk test and Mauchly’s Test of Sphericity, respectively.

Previous research incorporating a comparison of hydrolysed versus non-hydrolysed milk protein beverages showed a difference in amino acid uptake of 1.4 mmol across a 6 hours post-ingestion period. Assuming a similar difference in magnitude in amino acid concentration accumulation over a four-hour period between hydrolysed and non-hydrolysed protein beverages, a sample size of 8 participants would enable detection of a significant difference (significance level 0.05, 80% power, SD 1.0 mmol +/-4 h/L).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2025
Actual
Date of last participant enrolment
Anticipated
10/11/2025
Actual
Date of last data collection
Anticipated
12/12/2025
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318138 0
Government body
Name [1] 318138 0
CSIRO
Country [1] 318138 0
Australia
Primary sponsor type
University
Name
Swinburne University
Address
Country
Australia
Secondary sponsor category [1] 320522 0
None
Name [1] 320522 0
Address [1] 320522 0
Country [1] 320522 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316783 0
Swinburne University of Technology Human Research Ethics Committee
Ethics committee address [1] 316783 0
Ethics committee country [1] 316783 0
Australia
Date submitted for ethics approval [1] 316783 0
24/01/2025
Approval date [1] 316783 0
Ethics approval number [1] 316783 0

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

Contacts
Principal investigator
Name 138998 0
Dr Donny Camera
Address 138998 0
Swinburne University; Department of Health and Biostatistics; Room SPW224 Mail H21 PO Box 218 Hawthorn Vic, 3122
Country 138998 0
Australia
Phone 138998 0
+61 403166127
Fax 138998 0
Email 138998 0
[email protected]
Contact person for public queries
Name 138999 0
Donny Camera
Address 138999 0
Swinburne University; Department of Health and Biostatistics; Room SPW224 Mail H21 PO Box 218 Hawthorn Vic, 3122
Country 138999 0
Australia
Phone 138999 0
+61 403166127
Fax 138999 0
Email 138999 0
[email protected]
Contact person for scientific queries
Name 139000 0
Donny Camera
Address 139000 0
Swinburne University; Department of Health and Biostatistics; Room SPW224 Mail H21 PO Box 218 Hawthorn Vic, 3122
Country 139000 0
Australia
Phone 139000 0
+61 403166127
Fax 139000 0
Email 139000 0
[email protected]

Data sharing statement
Will sharing of individual participant data from this study be considered?
No
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.