Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001153707
Ethics application status
Approved
Date submitted
14/10/2013
Date registered
16/10/2013
Date last updated
6/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of resistance training combined with increased dietary protein (red meat) on muscle and brain health, and cognitive function in community-dwelling older adults: The Seniors Thinking, Exercise and Protein Study (STEPS)
Scientific title
Long-term effects of a protein enriched diet with lean red meat combined with progressive resistance compared to resistance training alone on muscle and brain health and cognitive function in community-dwelling older adults.
Secondary ID [1] 283272 0
Nil
Universal Trial Number (UTN)
Trial acronym
STEPS - Seniors Thinking, Exercise and Protein Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-related loss of muscle size and function (sarcopenia) 290145 0
Age-related decline in cognitive function 290146 0
Condition category
Condition code
Diet and Nutrition 290534 290534 0 0
Other diet and nutrition disorders
Musculoskeletal 290535 290535 0 0
Other muscular and skeletal disorders
Mental Health 290536 290536 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 6-month community-based randomised controlled trial with a 6-month follow-up in which participants aged 65 years and over will participate in a progressive resistance training program and consume a protein enriched diet achieved through the consumption of lean red meat on 3 days per week, or a carbohydrate control diet. The exercise program will be an individually tailored and supervised community-based program in which participants will undertake progressive resistance training three times a week. Each session will last 45-60 minutes and target all major muscle groups. Participants will perform 3 sets of 8-12 repetitions at a weight that cannot be lifted for more than 8-12 repetitions. Training will be made progressively more challenging by incorporating the principle of progressive overload (increments of 2-10% weekly). All training will be supervised by accredited exercise trainers. Participants in the lean red meat group will consume approximately 160g (cooked) of lean red meat three days per week on each training day while participants in the carbohydrate control group will consume at least half a cup of carbohydrates. Participants in both groups take one 1000 IU vitamin D3 capsule daily for the duration of the study. Exercise logs and completed exercise cards will be regularly checked by the trainers and will be used to monitor exercise adherence. Adherence to the lean red meat and carbohydrate diets will be monitored using a daily food calendars and compliance to the supplements will be monitored by a capsule count from bottles returned at 6 months. At the completion of the 6-month intervention, a follow-up assessment will be conducted 3 and 6 months post-intervention completion to evaluate any long-term behavioural changes with regard to maintaining participation in exercise and/or continuing to follow the intervention diet.
Intervention code [1] 287997 0
Lifestyle
Comparator / control treatment
Participants allocated to the comparator group will also undertake the same progressive resistance training program as those in the intervention group, but will consume a carbohydrate control diet.
Control group
Active

Outcomes
Primary outcome [1] 290561 0
Total body and regional (leg) lean tissue mass measured by DXA
Timepoint [1] 290561 0
Baseline and 6 months
Primary outcome [2] 290562 0
Leg muscle strength (three repetition maximum strength assessed on an isotonic leg press machine).
Timepoint [2] 290562 0
Baseline and 6 months
Primary outcome [3] 290563 0
Cognitive function (measured by Cogstate and BRIEF-A)
Timepoint [3] 290563 0
Baseline and 6 months
Secondary outcome [1] 304799 0
Balance and gait via the 30 second Sit-to-Stand, Timed-Up-and-Go test, Four-Square Step test and 4-m walk test.
Timepoint [1] 304799 0
Baseline and 6 months
Secondary outcome [2] 304800 0
Inflammatory, biochemical and hormonal measures (from blood and urine samples)
Timepoint [2] 304800 0
Baseline, 3 and 6 months
Secondary outcome [3] 304801 0
Neural plasticity (cortical excitability and inhibition) measured by transcranial magnetic stimulation
Timepoint [3] 304801 0
Baseline, 1, 2, 3 and 6 months.
Secondary outcome [4] 304802 0
Memory and mood measured by the Memory Assessment Questionnaire and Hospital Anxiety and Depression Scale
Timepoint [4] 304802 0
Baseline and 6 months
Secondary outcome [5] 304803 0
Health Related Quality of Life (SF36v2)
Timepoint [5] 304803 0
Baseline and 6 months
Secondary outcome [6] 304804 0
Blood pressure will be assessed after a 5 min seated rest in a quiet room using an automated blood pressure monitor. Three measurements will be taken with a 2-minute interval between readings; the mean of the final two readings will be used in the analysis.
Timepoint [6] 304804 0
Baseline and 6 months
Secondary outcome [7] 305065 0
Total body fat mass and percentage fat measured by DXA
Timepoint [7] 305065 0
Baseline and 6 months
Secondary outcome [8] 305066 0
Muscle and fat cross-sectional area at the femur measured by pQCT
Timepoint [8] 305066 0
Baseline and 6 months
Secondary outcome [9] 333566 0
Diet from two 24-hour food recalls
Timepoint [9] 333566 0
Baseline, 3, 6 and 12 months
Secondary outcome [10] 333567 0
Ongoing participation in an exercise program assessed via a brief questionnaire developed for this study
Timepoint [10] 333567 0
Adherence to the intervention was assessed at 12 months (6 months post the intervention)
Secondary outcome [11] 333568 0
Adherence to the intervention diet was assessed by a questionnaire developed for this study
Timepoint [11] 333568 0
6 months post intervention completion

Eligibility
Key inclusion criteria
Community-dwelling men and women aged 65 years and over. All participants enrolled in the study must also have received approval from their local physician to participate in the community-based intervention.
Minimum age
65 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded on the following criteria: 1) aged <65 years; 2) current or prior participation in resistance exercise (>1 week) and/or moderate-intensity physical activity greater than or equal to 150 minutes per week in the past 3 months; 3) acute or terminal illness, including current (treated or untreated) cancer or surgery/cessation of chemotherapy/radiotherapy less than 12-months ago; 4) history of a recent low trauma fracture with functional impairment that would limit participation in the exercise program; 5) body mass index (BMI) >40; 6) use of insulin to treat diabetes; 7) chronic liver disease, coeliac or inflammatory bowel disease, including ulcerative colitis or Crohn’s disease; 8) recent use of corticosteroids (past 6 months); or 9) inability to commit to the study and its requirements. Participants will not be excluded if they were currently taking vitamin D supplements, but will be asked to take the vitamin D that was provided as part of the study.

Eligible participants will then be screened using the Short Portable Mental Status Questionnaire (SPMSQ) and the Geriatric Depression Scale (GDS) to evaluate whether they are cognitively healthy and have no signs of depression. Those with a score of greater than two on the SPMSQ and/or a score of greater than six on the GDS will be excluded from the study. Participants that remained eligible will then be required to obtain approval from their local doctor to clear them of any contraindicated medical conditions to exercise, based upon American College of Sports Medicine (ACSM) guidelines, to participate in the program. Finally, participants will be asked to provide a fasted, morning blood sample to confirm that their estimated Glomerular Filtration Rate (eGFR) was >45 mL/min/1.73m2.

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)
Individuals interested in participating in the study will contact the research team at Deakin University to find out more about the study. They will be initially screened on the telephone to determine if they qualify for the study based on the above inclusion/exclusion criteria. Participants will also undergo a blood test to determine if their renal function permits them to take part. All participants must receive approval from their local physician prior to participating in the program. Randomisation will be at the level of the individual participant (ID), stratified by gender, using a computer-generated random number sequence by an independent researcher not involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be computer-generated (random number sequence), stratified by gender, by an independent researcher.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All statistical analyses will be conducted on an intention-to-treat (ITT) basis using Stata (version 11). Wherever possible, we will obtain endpoint measures from all withdrawals and include all randomised participants in our final ITT analysis. Time, group and group-by-time interactions will be examined using generalised linear mixed models. Hierarchical multiple regression analysis will be used to investigate the associated between various demographic, hormonal and inflammatory markers and neural plasticity on changes in muscle health and cognitive function. Potential covariates to be included in the model will include: age, sex, changes in medication and change in habitual physical activity.

The number of participants required for this study is based on power calculations for the expected changes in total body lean mass and lower limb muscle strength and cognitive function. Based on our previous study in elderly women (Daly et al. unpublished), we estimate that 55 older adults in each group will provide approximately 80% power to detect a 0.5 kg difference for the change in total body lean mass and a 18% difference for the change in muscle strength between the red meat group and control groups with an alpha level of 0.05 and estimated SD of 0.8 kg. This calculation allows for a possible 20% drop-out or loss to follow-up.

Since this will be the first study to have examined the effects of exercise combined with increased dietary protein on cognitive function, it is difficult to determine (or estimate) the magnitude of any effect from the intervention. Based on a number of previous trials, we estimated the effect size of increased protein on cognitive function to range from 0.5 to 1.1, which is considered to be a moderate to large effect. However, for our study we have used a conservative effect size of 0.4, which would equate to a 6-8% greater improvement in cognitive function (executive function) in the resistance training plus meat versus resistance training plus carbohydrate group. Please note that a larger effect may be observed but this is based on a conservative estimate. Based on this modest effect size, we estimate that with 76 participants per group (assuming a 20% attrition rate) we will have 80% power to detect the above differences after 6-months (152 participants in total) using an alpha level of less than 0.05 (two-tailed).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/01/2014
Actual
2/12/2013
Date of last participant enrolment
Anticipated
Actual
11/05/2015
Date of last data collection
Anticipated
Actual
27/05/2016
Sample size
Target
152
Accrual to date
Final
154
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288012 0
Commercial sector/Industry
Name [1] 288012 0
Meat and Livestock Australia
Country [1] 288012 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Centre for Physical Activity and Nutrition Research
221 Burwood Highway,
Burwood, Melbourne
Victoria, Australia 3125
Country
Australia
Secondary sponsor category [1] 286733 0
University
Name [1] 286733 0
The University of Melbourne
Address [1] 286733 0
Grattan Street
Parkville, Melbourne
Victoria, Australia 3010
Country [1] 286733 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289940 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 289940 0
Ethics committee country [1] 289940 0
Australia
Date submitted for ethics approval [1] 289940 0
Approval date [1] 289940 0
22/08/2013
Ethics approval number [1] 289940 0
2013-166

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

Contacts
Principal investigator
Name 43158 0
Prof Robin Daly
Address 43158 0
Deakin University
Centre for Physical Activity and Nutrition Research
221 Burwood Highway,
Burwood, Melbourne
Victoria, Australia 3125
Country 43158 0
Australia
Phone 43158 0
+61 3 9244 6040
Fax 43158 0
Email 43158 0
[email protected]
Contact person for public queries
Name 43159 0
Jenny Gianoudis
Address 43159 0
Deakin University
Centre for Physical Activity and Nutrition Research
221 Burwood Highway,
Burwood, Melbourne
Victoria, Australia 3125
Country 43159 0
Australia
Phone 43159 0
+61 3 9246 8286
Fax 43159 0
Email 43159 0
[email protected]
Contact person for scientific queries
Name 43160 0
Robin Daly
Address 43160 0
Deakin University
Centre for Physical Activity and Nutrition Research
221 Burwood Highway,
Burwood, Melbourne
Victoria, Australia 3125
Country 43160 0
Australia
Phone 43160 0
+61 3 9244 6040
Fax 43160 0
Email 43160 0
[email protected]

No information has been provided regarding IPD availability


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
EmbaseThe effects of a protein enriched diet with lean red meat combined with a multi-modal exercise program on muscle and cognitive health and function in older adults: Study protocol for a randomised controlled trial.2015https://dx.doi.org/10.1186/s13063-015-0884-x
EmbaseSelenium status is not associated with cognitive performance: A cross-sectional study in 154 older Australian adults.2018https://dx.doi.org/10.3390/nu10121847
EmbaseImpact of fractional excretion of sodium on a single morning void urine collection as an estimate of 24-hour urine sodium.2019https://dx.doi.org/10.1111/jch.13725
EmbaseEffect of lean red meat combined with a multicomponent exercise program on muscle and cognitive function in older adults: A 6-month randomized controlled trial.2020https://dx.doi.org/10.1093/ajcn/nqaa104
EmbaseEffects of a Multi-component, Resistance-Based Exercise Program Combined with Additional Lean Red Meat on Health-Related Quality of Life in Older Adults: Secondary Analysis of a 6-Month Randomized Controlled Trial.2023https://dx.doi.org/10.1007/s12603-023-1915-1
N.B. These documents automatically identified may not have been verified by the study sponsor.