Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000127404p
Ethics application status
Not yet submitted
Date submitted
17/01/2025
Date registered
4/02/2025
Date last updated
4/02/2025
Date data sharing statement initially provided
4/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Almond protein powder and hydration responses in postmenopausal women.
Scientific title
Investigating the impact of protein powders on hydration markers and the hyper-aminoacidaemia response to plant-based milk drinks in postmenopausal women (ALMOND ProFIT-AAP).
Secondary ID [1] 313729 0
None
Universal Trial Number (UTN)
Trial acronym
ALMOND ProFIT-AAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postmenopausal 336331 0
Condition category
Condition code
Reproductive Health and Childbirth 332870 332870 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The five supplementation protocols are as follows:
• Water only (500 mL) (comparator treatment)
• Almond milk (500 mL) (comparator treatment)
• Almond protein powder (28g protein content, topped up to 500 mL with almond milk)
• Whey protein powder (28g protein content, topped up to 500 mL with almond milk)
• Soy protein powder (28g protein content, topped up to 500 mL with almond milk)
o Note, all treatments excepting water will be flavoured with chocolate flavouring to mask the administered treatment.

Each treatment is consumed once only, in a cross-over format.

Washout between sessions is to be a minimum of two whole days.

Participants will be asked to arrive having completed an overnight fast (minimum 8 hours, excepting water intake which is to be recorded and replicated).

Adherence to the interventions themselves will be verified by the research team on hand during that session.
Intervention code [1] 330324 0
Treatment: Other
Intervention code [2] 330325 0
Lifestyle
Comparator / control treatment
This study contains two 'comparator' treatments - the water only and the almond milk treatments. The water only treatment provides a comparator for assessment of hydration markers, the almond milk treatment provides a comparator for amino acid profile markers.

The almond milk treatment is to be considered the reference comparator.
Control group
Active

Outcomes
Primary outcome [1] 340393 0
Hydration status will be considered a composite primary outcome, using each and all of changes in: Body mass, total body water, fluid volume ingested, urine volume excreted, plasma volume, urine specific gravity, urine colour, urine osmolality.
Timepoint [1] 340393 0
All measures collected at baseline, and then 15, 30, 45, 60 (primary timepoint), 90, 120 and 180 min following completion of ingestion of the relevant treatment in that session.
Primary outcome [2] 340394 0
Aminod acid profile, as assessed via assay analysis for leucine concentration in plasma.
Timepoint [2] 340394 0
Collected at baseline, and then 15, 30, 45, 60 (primary timepoint), 90, 120 and 180 min post ingestion of the relevant treatment in that session.
Secondary outcome [1] 444466 0
Appetite Assessment
Timepoint [1] 444466 0
Questionnaire completed at baseline, and then at 15, 30, 45, 60, 90, 120, 180 min post ingestion of the relevant treatment in that session.
Secondary outcome [2] 444468 0
Supplement Belief
Timepoint [2] 444468 0
Questionnaire is completed once, immediately after supplementation is completed.
Secondary outcome [3] 443944 0
Supplement Acceptability
Timepoint [3] 443944 0
Completed once, immediately after supplementation is finished.
Secondary outcome [4] 444467 0
Gastrointestinal Symptoms
Timepoint [4] 444467 0
Questionnaire completed at baseline, and then at 15, 30, 45, 60, 90, 120, 180 min post ingestion of the relevant treatment in that session.

Eligibility
Key inclusion criteria
• Biological females.
• Have undergone natural menopause; no menstrual bleeds for 12 consecutive months.
• Weight stable (no more than +/-2 kgs of weight change in last 2 months).
• Continuously using or not using hormone therapy for more than 12 months.
Minimum age
50 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Allergy to nuts.
Non-controlled high-blood pressure.
History of myopathic, neuropathic, skeletal, thrombotic, or cardiovascular disorders.
Any thyroid disorder (treated or untreated).
Anticipated absence for more than 1 week during the study period.
Current smokers.
Current chronic disease including cancer, diabetes, cardiovascular disease, chronic liver disease, and gastrointestinal disorders that affects nutrient absorption.
Following a vegan diet.

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 will be concealed by use of numbered bottles/containers for the treatments are NOT water only.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using 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
Efficacy
Statistical methods / analysis
A primary analysis of intention to treat (ITT) will be conducted of all the participants that have completed the trial. Between-group (treatment) comparisons will be made using linear models adjusting for baseline outcome level and stratification factors (body composition). Outcome variables will be log-transformed where necessary to satisfy parametric assumptions. All tests will be two-tailed with statistical significance set at p?<?0.05.

Using G*Power, a sample size of 14 participants will satisfy conventional statistical power requirements. A sample size of 14 exceeds the suggested number of participants returned from two power calculations, drawing on prior data assessing hydration outcomes following fluid ingestion [Maughan et al. 2016], and on data assessing amino acid profile responses to ingestion of a protein supplement [Farnfield et al. 2009].

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318196 0
Commercial sector/Industry
Name [1] 318196 0
Almond Board of California
Country [1] 318196 0
United States of America
Primary sponsor type
Individual
Name
Dr David Lee Hamilton of Deakin University
Address
Country
Australia
Secondary sponsor category [1] 320583 0
None
Name [1] 320583 0
Address [1] 320583 0
Country [1] 320583 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316847 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 316847 0
Ethics committee country [1] 316847 0
Australia
Date submitted for ethics approval [1] 316847 0
21/02/2025
Approval date [1] 316847 0
Ethics approval number [1] 316847 0

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

Contacts
Principal investigator
Name 139186 0
Dr David Lee Hamilton
Address 139186 0
Deakin University, 75 Pigdons Rd, Waurn Ponds VIC 3216
Country 139186 0
Australia
Phone 139186 0
+61 3 924 45207
Fax 139186 0
Email 139186 0
[email protected]
Contact person for public queries
Name 139187 0
Dr Charles Urwin
Address 139187 0
Deakin University, 221 Burwood Hwy, Burwood VIC, 3125
Country 139187 0
Australia
Phone 139187 0
+61 3 924 68958
Fax 139187 0
Email 139187 0
[email protected]
Contact person for scientific queries
Name 139188 0
Dr Charles Urwin
Address 139188 0
Deakin University, 221 Burwood Hwy, Burwood VIC, 3125
Country 139188 0
Australia
Phone 139188 0
+61 3 924 68958
Fax 139188 0
Email 139188 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Given the potential medical sensitivity of the data to be collected from participants in this study, the research team have elected not to plan to share this data openly at this stage.



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.