Trial Review

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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
Scientific title
ALMOND ProFIT-PM – Evaluating the effect of almond protein powder on fitness training in overweight menopausal females
Secondary ID [1] 312747 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic dysregulation 335483 0
Sarcopenia 335484 0
Overweight 335597 0
menopause 334979 0
Condition category
Condition code
Metabolic and Endocrine 332164 332164 0 0
Metabolic disorders
Physical Medicine / Rehabilitation 332043 332043 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 329764 0
Treatment: Other
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).
Control group
Placebo

Outcomes
Primary outcome [1] 339643 0
Total body lean muscle mass will be assessed using a non-invasive method referred to as dual energy X-ray absorptiometry (DXA)
Timepoint [1] 339643 0
Pre-Intervention (Baseline week 1) and at 12-weeks (Post completion of the intervention)
Secondary outcome [1] 442500 0
Changes in triglycerides (TG) levels between groups.
Timepoint [1] 442500 0
Pre-Intervention (Baseline week 1) and at 12-weeks (Post completion of the intervention)
Secondary outcome [2] 440718 0
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.
Timepoint [2] 440718 0
Pre-Intervention (Baseline week 1) and, 2, 5, 8 at 12-weeks (Post completion of the intervention)
Secondary outcome [3] 440713 0
3-repeition maximum (3RM) for upper body strength
Timepoint [3] 440713 0
Pre-Intervention (Baseline week 1) and at 12-weeks (Post completion of the intervention)
Secondary outcome [4] 441678 0
Handgrip strength
Timepoint [4] 441678 0
Pre-Intervention (Baseline week 1) and at 12-weeks (Post completion of the intervention)
Secondary outcome [5] 440715 0
Cardiovascular fitness, as measured by VO2peak using a cycle ergometer, will be compared between the almond protein and placebo groups.
Timepoint [5] 440715 0
Pre-Intervention (Baseline week 1) and at 12-weeks (Post completion of the intervention)
Secondary outcome [6] 440716 0
Insulin Sensitivity
Timepoint [6] 440716 0
Pre-Intervention (Baseline week 1) and at 12-weeks (Post completion of the intervention)
Secondary outcome [7] 440714 0
Changes in HDL-C levels between groups
Timepoint [7] 440714 0
Pre-Intervention (Baseline week 1) and at 12-weeks (Post completion of the intervention)
Secondary outcome [8] 441679 0
Supplement acceptability
Timepoint [8] 441679 0
Pre-Intervention (Baseline week 1) and, 2, 5, 8 at 12-weeks (Post completion of the intervention)
Secondary outcome [9] 441680 0
Dietary intake (protein, energy, fibre etc)
Timepoint [9] 441680 0
baseline (week 1), and at weeks 2, 5, 8, and 12 (post-intervention completion).
Secondary outcome [10] 440719 0
Changes in fat mass
Timepoint [10] 440719 0
Pre-Intervention (Baseline week 1) and at 12-weeks (Post completion of the intervention)
Secondary outcome [11] 441681 0
Glucose control
Timepoint [11] 441681 0
Pre-Intervention (Baseline week 1) and at 12-weeks (Post completion of the intervention)
Secondary outcome [12] 441685 0
Changes in total cholesterol levels between groups.
Timepoint [12] 441685 0
Pre-Intervention (Baseline week 1) and at 12-weeks (Post completion of the intervention)
Secondary outcome [13] 441682 0
Changes in LDL-C levels between groups.
Timepoint [13] 441682 0
Pre-Intervention (Baseline week 1) and at 12-weeks (Post completion of the intervention)
Secondary outcome [14] 441677 0
3-repeition maximum (3RM) for lower body strength
Timepoint [14] 441677 0
Pre-Intervention (Baseline week 1) and at 12-weeks (Post completion of the intervention)

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

Minimum age
50 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/03/2025
Actual
31/03/2025
Date of last participant enrolment
Anticipated
1/10/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317178 0
Commercial sector/Industry
Name [1] 317178 0
California Almonds: Almond Board of California
Country [1] 317178 0
United States of America
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 319953 0
None
Name [1] 319953 0
Address [1] 319953 0
Country [1] 319953 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315922 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 315922 0
Ethics committee country [1] 315922 0
Australia
Date submitted for ethics approval [1] 315922 0
27/09/2024
Approval date [1] 315922 0
14/03/2025
Ethics approval number [1] 315922 0
2024/HE000126

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

Contacts
Principal investigator
Name 136226 0
Dr David Lee Hamilton
Address 136226 0
Deakin University Waurn Ponds Campus, 75 Pigdons, Waurn Ponds, VIC 3216
Country 136226 0
Australia
Phone 136226 0
+61 3 92445207
Fax 136226 0
Email 136226 0
[email protected]
Contact person for public queries
Name 136227 0
David Lee Hamilton
Address 136227 0
Deakin University Waurn Ponds Campus, 75 Pigdons, Waurn Ponds, VIC 3216
Country 136227 0
Australia
Phone 136227 0
+61 3 92445207
Fax 136227 0
Email 136227 0
[email protected]
Contact person for scientific queries
Name 136228 0
David Lee Hamilton
Address 136228 0
Deakin University Waurn Ponds Campus, 75 Pigdons, Waurn Ponds, VIC 3216
Country 136228 0
Australia
Phone 136228 0
+61 3 92445207
Fax 136228 0
Email 136228 0
[email protected]

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:
• 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.