Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001034426
Ethics application status
Approved
Date submitted
4/08/2025
Date registered
18/09/2025
Date last updated
18/09/2025
Date data sharing statement initially provided
18/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of High-Protein Beverage Supplementation and Resistance Training on Cardiovascular Health and Physical Function in Post-Ischemic Stroke Survivors
Scientific title
Effect of High-Protein Beverage Supplementation and Resistance Training on Cardiovascular Health and Physical Function in Post-Ischemic Stroke Survivors
Secondary ID [1] 315161 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-Ischemic Stroke Rehabilitation 336974 0
Condition category
Condition code
Stroke 333438 333438 0 0
Ischaemic
Musculoskeletal 333439 333439 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 333440 333440 0 0
Other physical medicine / rehabilitation
Cardiovascular 335041 335041 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Design and groups
Randomised, controlled, partially blinded, three-arm trial with 1:1:1 allocation:
• PLA (placebo only): isocaloric carbohydrate beverage; no resistance training.
• RT-PLA: resistance training + isocaloric carbohydrate beverage.
• RT-WP: resistance training + whey protein hydrolysate beverage.
Phasing
Two phases run concurrently with the same participants and timepoints (Day 1, Day 45, Day 90).
Phase 1 (Acute in-lab challenge):
• Participants arrive fasted (nil-by-mouth except water for 8 h).
• After baseline measures, all participants consume a standardised whey protein hydrolysate beverage (20 g; Dymatize ISO100 Hydrolyzed).
• Blood and cardiovascular measures are collected at 30 min, 1 h, and 3 h post-consumption.
Phase 2 (Home-based 90-day intervention):
• RT-WP: Home-based resistance training (3×/week for 90 days) + 20 g whey protein hydrolysate within 30 min post-session.
• RT-PLA: Same training schedule + isocaloric maltodextrin beverage within 30 min post-session.
• PLA: No structured training; maltodextrin beverage 3×/week at a consistent morning time (07:00–10:00).
Resistance training protocol
• Sessions 45–60 min, 3×/week for 12 weeks (36 sessions). Exercises include banded seated rows, chest press, leg press, leg extension, and biceps curl.
• Intensity: moderate (RPE 11–13). Load progression every ~2 weeks.
• Sessions performed at home with elastic bands; participants receive familiarisation at baseline and weekly remote check-ins.
• Program designed and progressed by the coordinating investigator (certified personal trainer/exercise professional).
• Adherence/fidelity monitoring: Logbooks (sessions completed, beverage timing, RPE, notes). Sachet accountability (count/return of used/unused sachets at Day 45 & Day 90).
Beverage protocol
• Pre-weighed coded sachets (20 g whey protein hydrolysate or isocaloric maltodextrin) in identical flavour/appearance.
• Mixed with 250–300 mL water and consumed immediately.
Intervention code [1] 330737 0
Rehabilitation
Intervention code [2] 330738 0
Treatment: Other
Comparator / control treatment
PLA (placebo only) control: Isocaloric maltodextrin beverage, 20 g per sachet, 3×/week for 90 days. No structured resistance training. Beverage consumed at a consistent self-selected morning window (07:00–10:00). Adherence tracked via sachet accountability, logbooks, and weekly check-ins.
Control group
Placebo

Outcomes
Primary outcome [1] 341010 0
Systolic and diastolic blood pressure (mmHg)
Timepoint [1] 341010 0
Both Phase 1 (acute effects) and Phase 2 (chronic effects) are assessed concurrently: Phase 2 (chronic effects): Baseline (Day 1, pre-intervention), Midpoint (Day 45), and End of Study (Day 90). Phase 1 (acute effects): Baseline (fasted, pre-beverage) and at 30 min, 1 h, and 3 h post-beverage on Days 1, 45, and 90.
Primary outcome [2] 341011 0
Six-Minute Walk Test (6MWT) distance (meters)
Timepoint [2] 341011 0
Both phases are assessed at the same scheduled visits. Phase 2 (chronic effects): Baseline (Day 1, pre-intervention), Midpoint (Day 45), and End of Study (Day 90). Phase 1 (acute effects): At the same visits (Days 1, 45, and 90), measured pre-beverage (fasted) and at 30 min, 1 h, and 3 h post-beverage.
Primary outcome [3] 342524 0
High-sensitivity C-reactive protein (CRP; mg/L)
Timepoint [3] 342524 0
Both phases are assessed at the same scheduled visits. Phase 2 (chronic effects): Baseline (Day 1, pre-intervention), Midpoint (Day 45), and End of Study (Day 90). Phase 1 (acute effects): At the same visits (Days 1, 45, and 90), measured pre-beverage (fasted) and at 30 min, 1 h, and 3 h post-beverage.
Secondary outcome [1] 445782 0
Fasting lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides)
Timepoint [1] 445782 0
Baseline (Day 1, pre-intervention), Day 45, Day 90. Phase 1 acute analyses at the same visits: pre-beverage (fasted), 30 min, 1 h, 3 h post-beverage.
Secondary outcome [2] 445783 0
HbA1c (% or mmol/mol)
Timepoint [2] 445783 0
Baseline (Day 1, pre-intervention), Day 90.
Secondary outcome [3] 445784 0
Resting heart rate variability (HRV)
Timepoint [3] 445784 0
Baseline (Day 1, pre-intervention), Day 45, Day 90. Phase 1 acute analyses at the same visits: pre-beverage (fasted), 30 min, 1 h, 3 h post-beverage.
Secondary outcome [4] 451164 0
Cardiac output (CO)
Timepoint [4] 451164 0
Baseline (Day 1, pre-intervention), Day 45, Day 90. Phase 1 acute analyses at the same visits: pre-beverage (fasted), 30 min, 1 h, and 3 h post-beverage.
Secondary outcome [5] 451165 0
Stroke volume (SV)
Timepoint [5] 451165 0
Baseline (Day 1, pre-intervention), Day 45, Day 90. Phase 1 acute analyses at the same visits: pre-beverage (fasted), 30 min, 1 h, and 3 h post-beverage.
Secondary outcome [6] 451166 0
Handgrip strength (kg)
Timepoint [6] 451166 0
Baseline (Day 1, pre-intervention), Day 45, Day 90.
Secondary outcome [7] 451768 0
Timed Up and Go (TUG; seconds)
Timepoint [7] 451768 0
Baseline (Day 1, pre-intervention), Day 45, Day 90.
Secondary outcome [8] 451769 0
30-second Chair Stand test (repetitions)
Timepoint [8] 451769 0
Baseline (Day 1, pre-intervention), Day 45, Day 90.
Secondary outcome [9] 451770 0
Body mass index (kg/m²)
Timepoint [9] 451770 0
Baseline (Day 1), Day 45, Day 90.
Secondary outcome [10] 451771 0
Body composition (composite of lean mass, body fat %)
Timepoint [10] 451771 0
Baseline (Day 1), Day 45, Day 90.
Secondary outcome [11] 451773 0
Body circumferences (composite of waist, hip, mid-upper arm, thigh, calf)
Timepoint [11] 451773 0
Baseline (Day 1), Day 45, Day 90.
Secondary outcome [12] 451774 0
Plasma amino acid profile (leucine, isoleucine, valine, glutamine, arginine, lysine)
Timepoint [12] 451774 0
Baseline (Day 1, pre-intervention), Day 45, Day 90. Phase 1 acute analyses at the same visits: pre-beverage (fasted), 30 min, 1 h, 3 h post-beverage.
Secondary outcome [13] 451775 0
Edmonton Frail Scale (EFS)
Timepoint [13] 451775 0
Baseline (Day 1), Day 90.
Secondary outcome [14] 451776 0
Physical activity
Timepoint [14] 451776 0
Baseline (Day 1), Day 45, Day 90.
Secondary outcome [15] 451777 0
Dietary protein intake (g/day)
Timepoint [15] 451777 0
(Day 1), Day 90.
Secondary outcome [16] 451778 0
Protein Screener 55+ (Pro55+) risk classification
Timepoint [16] 451778 0
Baseline (Day 1), Day 90.
Secondary outcome [17] 451779 0
Leeds Sleep Evaluation Questionnaire (LSEQ)
Timepoint [17] 451779 0
Baseline (Day 1), Day 45, Day 90
Secondary outcome [18] 451780 0
SARC-F score (sarcopenia risk)
Timepoint [18] 451780 0
Baseline (Day 1), Day 90.
Secondary outcome [19] 451781 0
Participant expectations and experiences (acceptability, barriers/facilitators)
Timepoint [19] 451781 0
Baseline (pre-intervention, Week 0) and End of Study (Week 12).

Eligibility
Key inclusion criteria
Aged 45-80 years
Medical clearance from GP
Experienced an ischemic stroke at least one year prior
BMI between 18 and 35 kg/m²
Minimum age
45 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe cognitive impairment or inability to follow study procedures.

Uncontrolled cardiovascular disease or other serious medical conditions.

Currently participating in another clinical trial or intervention that could interfere with the study.

Pregnancy or breastfeeding.

Severe musculoskeletal conditions that would limit participation in physical activities.

History of allergy or adverse reactions to whey protein or any study supplement ingredients.

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)
Group assignments placed in sequentially numbered, opaque, sealed envelopes (SNOSE), prepared off-site. On enrolment, the next envelope is opened by a researcher not involved in outcome assessment. Beverage sachets are identical in appearance/flavour and labelled with a code. The beverage code key is held by an independent statistician until database lock.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation implemented by an independent statistician using a computer-generated sequence with permuted blocks, stratified by age (45–64 / 65–80) and BMI (18–24.9 / 25–35).
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
According to G*Power analysis (F tests - ANOVA: Repeated measures, within factors), for an effect size of 0.5 with a power of 0.8 at an alpha level of p < 0.05 for three groups (Resistance Training + Protein Supplementation, Resistance Training + Placebo, Placebo), with three time points (Day 1, Day 45, Day 90), the estimated sample size is 12 participants per group. However, considering the potential for participant dropout, we aim to recruit 20 participants per group.

Statistical analysis will be performed using SPSS (Statistical Package for the Social Sciences). The main analysis will include repeated measures ANOVA to assess the effects of the interventions on primary and secondary outcomes over the three time points. Pairwise comparisons will be conducted post-hoc where necessary. Data normality will be tested using the Shapiro-Wilk test, and appropriate transformations will be applied if required. Effect sizes will be reported for all significant findings.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
1/06/2026
Actual
Date of last data collection
Anticipated
31/10/2026
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 26954 0
New Zealand
State/province [1] 26954 0
Auckland

Funding & Sponsors
Funding source category [1] 318658 0
University
Name [1] 318658 0
Massey University — Postgraduate Research Support (School of Sport, Exercise and Nutrition).
Country [1] 318658 0
New Zealand
Primary sponsor type
University
Name
Massey university
Address
Country
New Zealand
Secondary sponsor category [1] 321081 0
None
Name [1] 321081 0
Address [1] 321081 0
Country [1] 321081 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317272 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 317272 0
Ethics committee country [1] 317272 0
New Zealand
Date submitted for ethics approval [1] 317272 0
21/01/2025
Approval date [1] 317272 0
04/04/2025
Ethics approval number [1] 317272 0
2025 EXP 21872

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

Contacts
Principal investigator
Name 140526 0
Prof Ajmol Ali
Address 140526 0
Massey University - Albany College of Sport, Exercise and Nutrition, SNW Extension Building Private Bag 102 904 North Shore Auckland 0745
Country 140526 0
New Zealand
Phone 140526 0
+64 21 781 333
Fax 140526 0
Email 140526 0
[email protected]
Contact person for public queries
Name 140527 0
Shamirah Nabbosa
Address 140527 0
Massey University - Albany College of Sport, Exercise and Nutrition, SNW Extension Building Private Bag 102 904 North Shore Auckland 0745
Country 140527 0
New Zealand
Phone 140527 0
+64 224199381
Fax 140527 0
Email 140527 0
[email protected]
Contact person for scientific queries
Name 140528 0
Ajmol Ali
Address 140528 0
Massey University - Albany College of Sport, Exercise and Nutrition, SNW Extension Building Private Bag 102 904 North Shore Auckland 0745
Country 140528 0
New Zealand
Phone 140528 0
+64 21 781 333
Fax 140528 0
Email 140528 0
[email protected]

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


What supporting documents are/will be available?



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.