Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001088235
Ethics application status
Approved
Date submitted
18/06/2018
Date registered
28/06/2018
Date last updated
4/06/2019
Date data sharing statement initially provided
4/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a high protein milk drink with or without resistance training on muscle mass, muscle strength and functional performance in healthy active older adults.
Scientific title
Effect of a high protein milk drink with or without resistance training on muscle mass, muscle strength and functional performance in healthy active older adults.
Secondary ID [1] 295127 0
N/A
Universal Trial Number (UTN)
Trial acronym
ActiveAge
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Effects of aging on skeletal muscle mass and functional performance 308385 0
Condition category
Condition code
Musculoskeletal 307378 307378 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete a 12-week intervention trial and be randomly allocated into one of 4 groups:

1. Dairy group
Will be provided with a dairy product, standardised food provisions* and Actigraph monitor.
2. Resistance training group
Resistance training intervention, Ad libitum food + Actigraph monitor.
3. Dairy group plus resistance training intervention
Dairy product and resistance training intervention, standardised food provisions* and Actigraph monitor.
4. Control group
Ad libitum food + Actigraph monitor.

*standardised food provisions include providing participants with ready made meals and snacks that will provide participants with 100% of total estimated energy and protein requirements based on Schofield (BMR+ PAL) equations and in accordance to the Australian healthy eating guidelines.

Dairy group:
Nutrition intervention will be facilitated by a Dietitian. Participants in the dairy trials (groups 1 and 2) will be provided with a 250ml tetra pack of milk, which the participants will be asked to consume twice a day.
1 with their breakfast meal and the other either post training or at lunch time. Participants will be required to return their empty milk containers to test for compliance. When in the laboratory participants will be required to drink their beverage after completing their training in front of a researcher.
The nutritional intervention will be administered by a dietitian, which will picked up by the participants on a weekly basis.


Exercise group:
Those allocated in the exercise trials (groups 2 and 3) will be required to attend 3 supervised sessions a week. The duration of the exercise session, including adequate cardiovascular warm-up and cool-down, will be ~60 minutes. The following exercises have been selected as they are low risk and easy for untrained individuals to complete. The following exercises have been selected based on previous established protocols as they are low risk and the most basic exercises for untrained individuals to complete. The following exercises have been used in previous studies thus deemed safe for older adults to perform.

Resistance Exercise Session:
• Leg Press
• Lateral pull down
• Chest press
• cable machine (shoulder and upper back)
• Core (abdominal and lower back)
Arms (Biceps and triceps)

The weights of these exercises will be determined based on individuals 1-RM (1 repetition maximum), which will be measured during baseline measurements. Participants will perform these exercises under the supervision of an exercise professional who is first-aid trained. The first 6 weeks of the trial the resistance training the intensity of the exercise will be 50-60% of 1RM or 5 to 6RPE (rate of perceived exertion) 3 sets of 10-15 repetitions. From 6 weeks to 12 weeks, participants will perform resistance training at 65-75% or 6.5-7 RPE of their 1RM of 3 sets and 6-8 repetitions.

All exercise sessions will be logged by the supervising researcher to monitor attendance.


All participants
All participants will be required to Wear an activity tracker (Actigraph) during the course of the 3-month trial.

Additionally, all participants are required to attend the laboratory on 3 separate occasions for measurements. This will be pre-trial, 6 weeks and 12 weeks (end of trial).

Intervention code [1] 301565 0
Lifestyle
Comparator / control treatment
Control group:
The control group trial will receive no intervention and will only be required to attend the laboratory on 3 separate occasions for primary and secondary outcome measurements. Ad libitum food (normal diet) + Actigraph monitor.

All participants
All participants will be required to Wear an activity tracker (Actigraph) during the course of the 3-month trial.

Additionally, all participants are required to attend the laboratory on 3 separate occasions for measurements. This will be pre-trial, 6 weeks and 12 weeks (end of trial).
Control group
Active

Outcomes
Primary outcome [1] 306350 0
Strength and performance outcomes:
1 –repetition maximum: Leg press, On pin loaded resistance machines
Timepoint [1] 306350 0
1. Baseline
2. 6 weeks (half way through the trial)
3. 12 weeks (post intervention, primary timepoint)
Primary outcome [2] 306351 0
Strength and performance outcomes:
1 –repetition maximum: Chest press, On pin loaded resistance machines




Timepoint [2] 306351 0
1. Baseline
2. 6 weeks (half way through the trial)
3. 12 weeks (post intervention, primary timepoint)
Primary outcome [3] 306422 0
Strength and performance outcomes:
1 –repetition maximum: Lateral pull down, On pin loaded resistance machines
Timepoint [3] 306422 0
1. Baseline
2. 6 weeks (half way through the trial)
3. 12 weeks (post intervention, primary timepoint)
Secondary outcome [1] 348244 0
Total body water. Measured using Bioelectrical impedance (BIA)
Timepoint [1] 348244 0
1. Baseline
2. 6 weeks (half way through the trial)
3. 12 weeks (post intervention)
Secondary outcome [2] 348510 0
Bone mineral density, using iDXA
Timepoint [2] 348510 0
1. Baseline
2. 6 weeks (half way through the trial)
3. 12 weeks (post intervention)
Secondary outcome [3] 348511 0
Blood sample: Heamatocrit and haemoglobin
Timepoint [3] 348511 0
1. Baseline
2. 6 weeks (half way through the trial)
3. 12 weeks (post intervention)
Secondary outcome [4] 348512 0
Blood glucose and plasma insulin
Timepoint [4] 348512 0
1. Baseline
2. 6 weeks (half way through the trial)
3. 12 weeks (post intervention)
Secondary outcome [5] 348520 0
Total and differential leukocyte counts, assessed using serum assay
Timepoint [5] 348520 0
1. Baseline
2. 6 weeks (half way through the trial)
3. 12 weeks (post intervention)
Secondary outcome [6] 348566 0
PRIMARY OUTCOME: total lean body mass, using iDXA
Timepoint [6] 348566 0
1. Baseline
2. 6 weeks (half way through the trial)
3. 12 weeks (post intervention, primary timepoint)
Secondary outcome [7] 348567 0
PRIMARY OUTCOME: vertical jump, using 400s Forceplate
Timepoint [7] 348567 0
1. Baseline
2. 6 weeks (half way through the trial)
3. 12 weeks (post intervention, primary timepoint)
Secondary outcome [8] 348568 0
PRIMARY OUTCOME: Total body water assessed using bioelectrical impedance
Timepoint [8] 348568 0
1. Baseline
2. 6 weeks (half way through the trial)
3. 12 weeks (post intervention, primary timepoint)
Secondary outcome [9] 348569 0
PRIMARY OUTCOME: Resting metabolic rate (RMR) using a RMR cart
Timepoint [9] 348569 0
1. Baseline
2. 6 weeks (half way through the trial)
3. 12 weeks (post intervention, primary timepoint)
Secondary outcome [10] 348570 0
PRIMARY OUTCOME: Incremental bike test, measuring Vo2max.
Timepoint [10] 348570 0
1. Baseline
2. 6 weeks (half way through the trial)
3. 12 weeks (post intervention, primary timepoint)
Secondary outcome [11] 348572 0
PRIMARY OUTCOME: Total body fat percentage, measuring using iDXA
Timepoint [11] 348572 0
1. Baseline
2. 6 weeks (half way through the trial)
3. 12 weeks (post intervention, primary timepoint)
Secondary outcome [12] 348573 0
PRIMARY OUTCOME: 20-minute bike test, measuring max power output and total distance (km) covered.
Timepoint [12] 348573 0
1. Baseline
2. 6 weeks (half way through the trial)
3. 12 weeks (post intervention, primary timepoint)

Eligibility
Key inclusion criteria
-Community dwelling male and female adults aged 50 years and older
-Physically capable, is defined as at least 3x30 minutes (90 minutes) of recreational exercise per week.
- Participants are required to not currently undergo strength/ resistance training and have not been involved in resistance training in the last 18 months.
- Low alcohol consumers (<2 standard drinks per day)
- Non-smokers
-BMI in the normal-overweight range (between 18.5-30.0 kg.m2)
-Normal resting blood pressure and blood glucose levels.
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Milk protein intolerance or allergies
2. Participants currently using natural health products such as whey protein or vitamins (will need to disuse during the course of the study)
3. Major surgery in the past 12 months
4. Acute coronary (e.g. myocardial infarction) or vascular event in the last year as well as uncontrolled coronary heart disease.
5. Injuries preventing safe exercise
6. Any chronic diseases such as: Diabetes mellitus, or gastrointestinal disease.
7. Stroke in the past 2 years
8. Orthopedic limitations that limit the participant in the exercise program
9. Diagnosed with or taking medication for thyroid condition
10. Weight loss or more than 5% of body weight over the last 6 months.
11. All medications that can interfere with muscle mass such as corticosteroids, testosterone replacement or anabolic drugs
12. Participants currently undergoing immunosuppressive therapy or hormone replacement therapy.

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)
Participants will be randomly allocated into one of the 4 experimental groups using a computer randomiser that will be allocated by a researcher completely separate from the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation, stratified for age and sex
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Microsoft Excel and the Statistical Package for the Social Sciences (SPSS) software will be utilised for statistical analysis of results. Multiple time points: repeated measures ANOVA with post hoc, Single time points: one-way ANOVA with post hoc. Non-parametric equivalent were applicable.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2018
Actual
2/08/2018
Date of last participant enrolment
Anticipated
15/11/2019
Actual
Date of last data collection
Anticipated
15/02/2020
Actual
Sample size
Target
48
Accrual to date
17
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 299719 0
Commercial sector/Industry
Name [1] 299719 0
Lion Drinks and Dairy
Country [1] 299719 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University, Department of Nutrition and Dietetics
264 Ferntree Gully Rd, Notting Hill VIC 3168
Australia
Country
Australia
Secondary sponsor category [1] 299175 0
None
Name [1] 299175 0
Address [1] 299175 0
Country [1] 299175 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300607 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 300607 0
Ethics committee country [1] 300607 0
Australia
Date submitted for ethics approval [1] 300607 0
Approval date [1] 300607 0
17/05/2018
Ethics approval number [1] 300607 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2777 2777 0 0
/AnzctrAttachments/375286-EThics approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 84202 0
Dr Ricardo Costa
Address 84202 0
Monash University, Department of Nutrition and Dietetics
264 Ferntree Gully Rd, Notting Hill VIC 3168
Country 84202 0
Australia
Phone 84202 0
+6139905 6861
Fax 84202 0
Email 84202 0
ricardo.costa@monash.edu
Contact person for public queries
Name 84203 0
Ricardo Costa
Address 84203 0
Monash University, Department of Nutrition and Dietetics
264 Ferntree Gully Rd, Notting Hill VIC 3168
Country 84203 0
Australia
Phone 84203 0
+6139905 6861
Fax 84203 0
Email 84203 0
ricardo.costa@monash.edu
Contact person for scientific queries
Name 84204 0
Ricardo Costa
Address 84204 0
Monash University, Department of Nutrition and Dietetics
264 Ferntree Gully Rd, Notting Hill VIC 3168
Country 84204 0
Australia
Phone 84204 0
+6139905 6861
Fax 84204 0
Email 84204 0
ricardo.costa@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseDoes intestinal epithelial integrity status in response to high-protein dairy milk beverage with or without progressive resistance training impact systemic inflammatory responses in an active aging population?.2022https://dx.doi.org/10.1371/journal.pone.0274210
EmbaseWhat is real change in submaximal cardiorespiratory fitness in older adults? Retrospective analysis of a clinical trial.2022https://dx.doi.org/10.1186/s40798-022-00447-6
N.B. These documents automatically identified may not have been verified by the study sponsor.