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Trial registered on ANZCTR
Registration number
ACTRN12625000133437
Ethics application status
Approved
Date submitted
15/10/2024
Date registered
6/02/2025
Date last updated
13/04/2025
Date data sharing statement initially provided
6/02/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
ALMOND ProFIT-PM – Evaluating the effect of almond protein powder on fitness training
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Scientific title
ALMOND ProFIT-PM – Evaluating the effect of almond protein powder on fitness training in overweight menopausal females
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Secondary ID [1]
312747
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Nil Known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metabolic dysregulation
335483
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Sarcopenia
335484
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Overweight
335597
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menopause
334979
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Condition category
Condition code
Metabolic and Endocrine
332164
332164
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0
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Metabolic disorders
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Physical Medicine / Rehabilitation
332043
332043
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A randomized controlled trial investigating the impact of almond protein supplementation combined with a 10-week progressive resistance and anaerobic training program on postmenopausal women's muscle strength, body composition, and metabolic health.
The goal of the study is to assess the effects of almond protein supplementation on muscle hypertrophy, strength, and metabolic health (glucose tolerance, blood lipids) in postmenopausal women. The study aims to investigate whether a plant-based protein source (almond protein) in conjunction with resistance training can improve body composition (increase lean mass, reduce fat mass), strength, and metabolic outcomes in this population, addressing concerns like menopause-related muscle loss (sarcopenia) and metabolic dysregulation.
Supplements: Participants in the intervention group receive an almond protein supplement made by mixing 250 ml of almond milk with 34 g of defatted almond meal (15 g protein). On training days, participants consume a double shake (500 ml almond milk with 68 g defatted almond meal, providing 30 g of protein). The control group consumes an energy-matched shake made from almond milk and malt or chocolate powder (4.6 g protein on workout days). Supplements are consumed with meals identified as low in protein (typically breakfast).
Exercise Protocol: A 10-week progressive resistance and high-intensity interval training (HIIT) program, consisting of two sessions per week focusing on major muscle groups. The resistance training includes exercises like leg press, chest press, and lat pull-down, using a progressive loading scheme starting at 65-70% of 1RM. HIIT sessions involve a cycle ergometer with increasing work intensity over the course of the program. Each session will run for ~1 hour with 40 minutes of resistance training followed by 20 minutes of HITT training. These sessions will be supervised by staff with exercise science backgrounds of groups of 2-3 per staff member. These sessions will be completed on non-consecutive days of the week. All sessions will be recorded for attendance.
Testing Equipment: Hand grip dynamometer, DXA for body composition, cycle ergometer for VO2peak, and tools for blood sampling and urine hydration tests.
Participants consume almond protein supplements or control drinks daily based on training or rest day schedules.
Regular assessments (pre- and post-intervention) for body composition (DXA), strength (3-RM testing), metabolic health (oral glucose tolerance test and blood lipid/hormone markers), and VO2peak.
Daily supplement intake is tracked via an app (EasyDietDiary), and compliance is monitored using date-stamped photos and returned supplement counting.
Duration: The study spans 12 weeks in total, including pre-testing (Day 1 & 2), a 10-week exercise and supplementation intervention, and post-testing (Visit 23).
Frequency: Exercise is conducted 2 times per week, with a combination of resistance training and HIIT in each session.
Supplement intake: Participants consume almond protein shakes once per day on rest days and twice per day on training days. Control group participants follow the same frequency using energy-matched shakes.
Total time commitment: ~4-5 hours for pre-testing (Day 1), ~3-4 hours for strength and VO2peak testing (Day 2), and a total of 10 weeks of intervention, followed by 8 hours of post-testing.
The almond protein supplement is consumed with meals identified as inadequate in protein, based on participants’ food diaries. The intensity of the resistance training is adjusted based on individual performance using a Reps in Reserve (RIR) approach to ensure progressive overload.
No modifications to the intervention are mentioned, but the intensity of exercise and supplement timing may be adjusted based on participant adherence and individual needs.
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Intervention code [1]
329764
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Treatment: Other
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Comparator / control treatment
The control group will receive the same exercise intervention as mentioned previously. The control group consumes an energy-matched shake made from almond milk and malt or chocolate powder (4.6 g protein on workout days). Supplements are consumed with meals identified as low in protein (typically breakfast).
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Total body lean muscle mass will be assessed using a non-invasive method referred to as dual energy X-ray absorptiometry (DXA)
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Assessment method [1]
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DEXA
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Timepoint [1]
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Pre-Intervention (Baseline week 1) and at 12-weeks (Post completion of the intervention)
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Secondary outcome [1]
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Changes in triglycerides (TG) levels between groups.
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Assessment method [1]
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blood samples
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Timepoint [1]
442500
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Pre-Intervention (Baseline week 1) and at 12-weeks (Post completion of the intervention)
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Secondary outcome [2]
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Changes in Appetite. We will compare any changes in appetite to determine if the almond protein group have a reduction due to the increase in protein and fibre.
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Assessment method [2]
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Appetite differences between groups will be assessed using validated subjective appetite evaluation tools, including the adapted Food Action Rating Scale (Schutz et al., 1965). This scale, which measures food acceptance, will be administered via an online questionnaire through REDcap. Reference: Schutz, H.G. (1965). A food action rating scale for measuring food acceptance. Journal of Food Science, 30, 365-374.
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Timepoint [2]
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Pre-Intervention (Baseline week 1) and, 2, 5, 8 at 12-weeks (Post completion of the intervention)
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Secondary outcome [3]
440713
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3-repeition maximum (3RM) for upper body strength
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Assessment method [3]
440713
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chest press- using 3-RM testing on machine weights
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Timepoint [3]
440713
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Pre-Intervention (Baseline week 1) and at 12-weeks (Post completion of the intervention)
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Secondary outcome [4]
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Handgrip strength
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Assessment method [4]
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Handgrip Dynameter
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Timepoint [4]
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Pre-Intervention (Baseline week 1) and at 12-weeks (Post completion of the intervention)
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Secondary outcome [5]
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Cardiovascular fitness, as measured by VO2peak using a cycle ergometer, will be compared between the almond protein and placebo groups.
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Assessment method [5]
440715
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cycle ergometer and a standard Vo2peak protocol
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Timepoint [5]
440715
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Pre-Intervention (Baseline week 1) and at 12-weeks (Post completion of the intervention)
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Secondary outcome [6]
440716
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Insulin Sensitivity
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Assessment method [6]
440716
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2-hour Oral Glucose Tolerance Test (OGTT) (75g of glucose) and blood samples
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Timepoint [6]
440716
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Pre-Intervention (Baseline week 1) and at 12-weeks (Post completion of the intervention)
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Secondary outcome [7]
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Changes in HDL-C levels between groups
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Assessment method [7]
440714
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Blood samples
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Timepoint [7]
440714
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Pre-Intervention (Baseline week 1) and at 12-weeks (Post completion of the intervention)
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Secondary outcome [8]
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Supplement acceptability
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Assessment method [8]
441679
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Questions regarding supplement acceptability, including taste and texture, will be evaluated using a hedonic general labeled magnitude scale, specifically developed for this study. The assessment will be conducted via REDcap.
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Timepoint [8]
441679
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Pre-Intervention (Baseline week 1) and, 2, 5, 8 at 12-weeks (Post completion of the intervention)
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Secondary outcome [9]
441680
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Dietary intake (protein, energy, fibre etc)
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Assessment method [9]
441680
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2-day food diaries will be collected at the following time points: baseline (week 1), and at weeks 2, 5, 8, and 12 (post-intervention completion). The food diaries will be completed using the Easy Diet Diary tool and analyzed using FoodWorks software to assess any changes in nutrition intake
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Timepoint [9]
441680
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baseline (week 1), and at weeks 2, 5, 8, and 12 (post-intervention completion).
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Secondary outcome [10]
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Changes in fat mass
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Assessment method [10]
440719
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DEXA
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Timepoint [10]
440719
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Pre-Intervention (Baseline week 1) and at 12-weeks (Post completion of the intervention)
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Secondary outcome [11]
441681
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Glucose control
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Assessment method [11]
441681
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2-hour Oral Glucose Tolerance Test (OGTT) (75g of glucose) and blood samples
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Timepoint [11]
441681
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Pre-Intervention (Baseline week 1) and at 12-weeks (Post completion of the intervention)
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Secondary outcome [12]
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Changes in total cholesterol levels between groups.
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Assessment method [12]
441685
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Blood samples
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Timepoint [12]
441685
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Pre-Intervention (Baseline week 1) and at 12-weeks (Post completion of the intervention)
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Secondary outcome [13]
441682
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Changes in LDL-C levels between groups.
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Assessment method [13]
441682
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Blood samples
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Timepoint [13]
441682
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Pre-Intervention (Baseline week 1) and at 12-weeks (Post completion of the intervention)
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Secondary outcome [14]
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3-repeition maximum (3RM) for lower body strength
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Assessment method [14]
441677
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3-repeition maximum (3RM) leg press using machine weight seated leg press
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Timepoint [14]
441677
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Pre-Intervention (Baseline week 1) and at 12-weeks (Post completion of the intervention)
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Eligibility
Key inclusion criteria
Inclusion Criteria
Biological females
Are between 50-65 years of age Have undergone natural menopause; no menstrual bleeds for 12 consecutive months
Overweight or obese (BMI 25-34.9 kg/m2)
Are not practicing progressive resistance training or challenging balance/mobility training (>1/week) in last 6 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?
No
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Key exclusion criteria
Exclusion Criteria
Allergy to nuts
Non-controlled high-blood pressure
History of myopathic, neuropathic, skeletal, thrombotic, or cardiovascular disorders
Thyroid issues must be controlled with medications
Anticipated absence for >1 wk during the study period
Current smokers
Functional impairment that would limit inclusion in the trial
Current chronic disease including cancer, diabetes, cardiovascular disease, chronic liver disease, and gastrointestinal disorders that affects nutrient absorption.
Musculoskeletal injury in the past 6 months
Did not received recent (last 6 months) medication treatment influencing muscle mass and strength (e.g., cancer-related chemotherapy)
Following a vegan diet
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Study design
Purpose of the study
Prevention
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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)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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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
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
31/03/2025
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Actual
31/03/2025
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Date of last participant enrolment
Anticipated
1/10/2025
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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
48
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Accrual to date
2
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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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California Almonds: Almond Board of California
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Address [1]
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Country [1]
317178
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United States of America
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Primary sponsor type
University
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Name
Deakin University
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Address
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Country
Australia
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Secondary sponsor category [1]
319953
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None
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Name [1]
319953
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Address [1]
319953
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Country [1]
319953
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315922
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Deakin University Human Research Ethics Committee (DUHREC)
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Ethics committee address [1]
315922
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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]
315922
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Australia
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Date submitted for ethics approval [1]
315922
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27/09/2024
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Approval date [1]
315922
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14/03/2025
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Ethics approval number [1]
315922
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2024/HE000126
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Summary
Brief summary
This research project will investigate the effects of daily almond protein supplementation on muscle mass, strength, body composition, and metabolic health in postmenopausal women (aged 50-65) undergoing a 10-week progressive resistance and high-intensity interval training (HIIT) program. The study aims to test the hypothesis that almond protein, a plant-based protein source, can enhance muscle hypertrophy, strength, and improve metabolic outcomes (e.g., glucose tolerance, blood lipids) when combined with resistance training.
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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 Waurn Ponds Campus, 75 Pigdons, Waurn Ponds, VIC 3216
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Country
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Australia
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Phone
136226
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+61 3 92445207
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Fax
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Email
136226
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[email protected]
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Contact person for public queries
Name
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David Lee Hamilton
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Address
136227
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Deakin University Waurn Ponds Campus, 75 Pigdons, Waurn Ponds, VIC 3216
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Country
136227
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Australia
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Phone
136227
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+61 3 92445207
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Fax
136227
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Email
136227
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[email protected]
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Contact person for scientific queries
Name
136228
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David Lee Hamilton
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Address
136228
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Deakin University Waurn Ponds Campus, 75 Pigdons, Waurn Ponds, VIC 3216
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Country
136228
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Australia
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Phone
136228
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+61 3 92445207
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Fax
136228
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Email
136228
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
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only researchers who provide a methodologically sound proposal
Conditions for requesting access:
•
-
What individual participant data might be shared?
•
All the de-identified data that is collected
What types of analyses could be done with individual participant data?
•
Review, meta-analyses etc
When can requests for individual participant data be made (start and end dates)?
From:
Beginning 3 months and ending 5 years following main results publication; no end date determined
To:
-
Where can requests to access individual participant data be made, or data be obtained directly?
•
Direct contact to PI
[email protected]
or corresponding author
[email protected]
that will be outlined on the manuscript
Are there extra considerations when requesting access to individual participant data?
No
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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