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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.
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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).
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Secondary ID [1]
313729
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None
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Universal Trial Number (UTN)
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Trial acronym
ALMOND ProFIT-AAP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Postmenopausal
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Condition category
Condition code
Reproductive Health and Childbirth
332870
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0
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Menstruation and menopause
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
330324
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Treatment: Other
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Intervention code [2]
330325
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Lifestyle
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Measures are assessed via collection of venous blood, collection of excreted urine, and completion of a body composition scan (bioelectrical impedence analysis).
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Timepoint [1]
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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.
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Primary outcome [2]
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Aminod acid profile, as assessed via assay analysis for leucine concentration in plasma.
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Assessment method [2]
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Collection of venous blood,
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Timepoint [2]
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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.
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Secondary outcome [1]
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Appetite Assessment
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Assessment method [1]
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Questionnaire designed for this study, where participants rate the extent to which they are experiencing hunger and other sensations such as desire to eat something salty or sweet.
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Timepoint [1]
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Questionnaire completed at baseline, and then at 15, 30, 45, 60, 90, 120, 180 min post ingestion of the relevant treatment in that session.
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Secondary outcome [2]
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Supplement Belief
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Assessment method [2]
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Questionnaire designed for this study, assessing the efficacy of blinding, whereby participants are asked to identify the supplement they ingested, and the confidence with which they believe this to be correct.
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Timepoint [2]
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Questionnaire is completed once, immediately after supplementation is completed.
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Secondary outcome [3]
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Supplement Acceptability
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Assessment method [3]
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Questionnaire designed for this study, where participants rate the extent to which participants 'like' ingestion of the relevant supplement.
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Timepoint [3]
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Completed once, immediately after supplementation is finished.
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Secondary outcome [4]
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Gastrointestinal Symptoms
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Assessment method [4]
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Questionnaire assessing the incidence and severity of various gastrointestinal symptoms. Questionnaire has shown acceptable reliability in detecting incidence and severity of these symptoms [Gaskell et al. 2019].
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Timepoint [4]
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Questionnaire completed at baseline, and then at 15, 30, 45, 60, 90, 120, 180 min post ingestion of the relevant treatment in that session.
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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.
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Minimum age
50
Years
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Maximum age
65
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer software.
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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].
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/05/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
14
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Almond Board of California
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Address [1]
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Country [1]
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United States of America
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Primary sponsor type
Individual
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Name
Dr David Lee Hamilton of Deakin University
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
320583
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Country [1]
320583
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
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Deakin University Human Research Ethics Committee (DUHREC)
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Ethics committee address [1]
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https://www.deakin.edu.au/research/support-for-researchers/research-integrity?a=438168
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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21/02/2025
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Approval date [1]
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Ethics approval number [1]
316847
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Summary
Brief summary
This study’s importance is drawn primarily from its focus on an under-represented demographic, which presents distinct and unique health needs. Postmenopausal women, as any other specific population, require tailored interventions to address physiological issues of importance. Assessing the efficacy of APP supplementation to induce favourable protein metabolism and hydration outcomes can advance scientific knowledge, as well as contributing to developing targeted strategies for health adaptations. Further to this, the findings of this study may offer insights of practical importance to practitioners working with postmenopausal women. Specifically, these results could inform public health programs that seek to improve the health and quality of life of postmenopausal women.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr David Lee Hamilton
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Address
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Deakin University, 75 Pigdons Rd, Waurn Ponds VIC 3216
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Country
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Australia
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Phone
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+61 3 924 45207
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Charles Urwin
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Address
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Deakin University, 221 Burwood Hwy, Burwood VIC, 3125
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Country
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Australia
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Phone
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+61 3 924 68958
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Charles Urwin
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Address
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Deakin University, 221 Burwood Hwy, Burwood VIC, 3125
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Country
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Australia
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Phone
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+61 3 924 68958
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Fax
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Email
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[email protected]
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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.
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