Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000383369
Ethics application status
Approved
Date submitted
7/03/2017
Date registered
14/03/2017
Date last updated
9/05/2019
Date data sharing statement initially provided
9/05/2019
Date results information initially provided
9/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ladies' Exercise Training and Supplement Study: LET'S MOVE To Improve Muscle Health and Function
Scientific title
Effects of a dairy-derived nutrition supplement combined with physical activity on health and physical function in 45-65 year old habitually sedentary women
Secondary ID [1] 290419 0
None
Universal Trial Number (UTN)
Trial acronym
LET'S Move!
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sedentary lifestyle 300759 0
Musculoskeletal health 300760 0
Subjective vitality, health and well-being 300761 0
Condition category
Condition code
Musculoskeletal 300598 300598 0 0
Other muscular and skeletal disorders
Diet and Nutrition 302004 302004 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a 4-month community-based randomised controlled trial in which sedentary women aged 45-65 years will participate in a multi-modal exercise program involving progressive resistance training and functional balance/mobility activities and be randomised to receive either: 1) a milk-based fortified supplement (powder dissolved in water) or 2) a milk-based non-fortified energy matched drink/powder (dissolved in water). The fortified milk product (FMP, 30 g dose, 2x per day at breakfast and lunch or within 1-2 hours of each exercise session: total 60 g/d) is largely comprised of milk powder (skim and whole), vitamins, minerals, complex milk lipids, and a small amount of hydrolysed fish collagen. It also contains low levels of Vitamins B12, B6, E and C. Each drink will contain approximately 418 kJ, 9 g protein, 634 mg calcium, 7.5 ug vitamin D, 86 mg magnesium and 2 mg zinc. The exercise program will be run within community leisure centres, individually tailored and supervised by qualified trainers. All participants will train twice a week within the leisure centres (45-60 minutes each) and after week 5 will be asked to complete one additional home based training session per week (15-20 minutes). The training will target all major muscle groups and participants will perform 3 sets of 8-12 repetitions at a moderate to high intensity. Training will be made progressively more challenging by incorporating the principle of progressive overload. Training will be supervised by accredited exercise trainers. Participants in both groups will be asked to consume their supplemental drink daily, once with breakfast and once at lunch/dinner (and within 1-2 hours after the exercise sessions on the three training days). Exercise logs and completed exercise cards will be regularly checked by the trainers and will be used to monitor exercise adherence. Adherence to the supplemental drink will be monitored using a daily food calendar.
Intervention code [1] 296252 0
Lifestyle
Intervention code [2] 297455 0
Prevention
Comparator / control treatment
Participants allocated to the comparator group will also undertake the same exercise program as those in the intervention group, but will consume a non-fortified energy matched drink product (30 g dose, 2x per day, total dose 60 g/d. The placebo (PLA) will predominantly containing carbohydrates (rice powder and whole milk powder), with no added vitamins or minerals.
Control group
Placebo

Outcomes
Primary outcome [1] 300011 0
Functional muscle power will be assessed by the Leonardo Mechanography 5- step stair climb test (ascent).
Timepoint [1] 300011 0
Baseline and week 16
Primary outcome [2] 301431 0
Functional muscle power will be assessed by the 10-step stair climb test (ascent).
Timepoint [2] 301431 0
Baseline and week 16
Secondary outcome [1] 328887 0
Total body and regional (legs and arms) lean tissue tissue mass will be measured by dual energy X-ray absorptiometry (DXA).
Timepoint [1] 328887 0
Baseline and week 16
Secondary outcome [2] 328888 0
Lower leg muscle strength (force) and velocity will be used to calculate muscle power of the knee extensors using the Keiser pneumatic resistance training equipment (leg press).
Timepoint [2] 328888 0
Baseline and week 16
Secondary outcome [3] 328889 0
Cardiorespiratory fitness will be estimated from a 2-minute step test
Timepoint [3] 328889 0
Baseline and week 16
Secondary outcome [4] 328892 0
Muscle density as measure of skeletal muscle fat infiltration at the mid-thigh (50% site) and calf (66% site) will be assessed by peripheral QCT (pQCT).
Timepoint [4] 328892 0
Baseline and week 16
Secondary outcome [5] 328893 0
Balance/sway will be assessed by single-leg balance with eyes closed while standing on a force plate.
Timepoint [5] 328893 0
Baseline and week 16
Secondary outcome [6] 328895 0
General flexibility will be assessed using the sit-and-reach test.
Timepoint [6] 328895 0
Baseline and week 16
Secondary outcome [7] 328900 0
Markers of hormonal/menopausal status: estrogen, FSH and progesterone
Timepoint [7] 328900 0
Baseline
Secondary outcome [8] 328901 0
Habitual physical activity and sedentary time (7-days) will be assessed using inclinometer and accelerometer readings.
Timepoint [8] 328901 0
Baseline and week 16
Secondary outcome [9] 328902 0
Dietary intake will be assessed by self-reported food intake over 3 days
Timepoint [9] 328902 0
Baseline, week 8 and week 16.
Secondary outcome [10] 328903 0
Perceptions of well being and vitality will be assessed using the Subjective Vitality Scale (VS)
Timepoint [10] 328903 0
Baseline and week 16
Secondary outcome [11] 328905 0
As an exploratory outcome, muscle biomarkers will be assessed using micro-RNA of muscle.
Timepoint [11] 328905 0
Baseline and week 16
Secondary outcome [12] 332610 0
Ankle dorsiflexion strength assessed using an isometric device.
Timepoint [12] 332610 0
Baseline and week 16
Secondary outcome [13] 332611 0
Grip strength using standard grip strength test (dominant arm).
Timepoint [13] 332611 0
Baseline and week 16
Secondary outcome [14] 332612 0
Functional muscle strength will be assessed using the 3 m timed up-and-go (TUG),
Timepoint [14] 332612 0
Baseline and week 16
Secondary outcome [15] 332613 0
Functional strength and power will be assessed using the sit-to-stand test and vertical jump test (squat static and countermovement jump).
Timepoint [15] 332613 0
Baseline and week 16 (Sit to stand will also be measured at week 8).
Secondary outcome [16] 332614 0
Walking speed will be measured the 4-m walk test – self paced and maximum speed),
Timepoint [16] 332614 0
Baseline and week 16
Secondary outcome [17] 332615 0
Functional mobility/dynamic balance will be measured using the four square step test (FSST) and choice stepping reaction time.
Timepoint [17] 332615 0
Baseline and week 16
Secondary outcome [18] 332616 0
Maximum ankle joint range of motion will be assessed using the dorsiflexion knee to wall test
Timepoint [18] 332616 0
Baseline and week 16
Secondary outcome [19] 332617 0
Descending stair climb using the Leonardo Mechanography Stair Climb Test
Timepoint [19] 332617 0
Baseline and week 16
Secondary outcome [20] 332618 0
Descending stair climb using the 10-step stair climb test
Timepoint [20] 332618 0
Baseline and week 16
Secondary outcome [21] 332619 0
Blood pressure will be measured using an automated blood pressure monitor after a 5-minute rest period seated in a quiet room
Timepoint [21] 332619 0
Baseline and week 16
Secondary outcome [22] 332620 0
Circulating markers of inflammation (serum IL-6, IL-10, TNF-a, hsCRP)
Timepoint [22] 332620 0
Baseline and week 16
Secondary outcome [23] 332621 0
Blood biomarkers of cardiometabolic health: fasting plasma glucose, serum insulin, fasting lipid profile (cholesterol, HDL and LDL-cholesterol and triglycerides)
Timepoint [23] 332621 0
Baseline and week 16
Secondary outcome [24] 332622 0
Blood biomarkers of bone and joint health: serum CTx-1, P1NP, PTH and vitamin D (25OHD); urinary CTX-2
Timepoint [24] 332622 0
Baseline and week 16
Secondary outcome [25] 332623 0
Biomarkers of oxidative stress: Plasma carbonyls, Red cell ratio of oxidised and reduced glutathione (GSH/GSSG), 7,8-Dihydro-8-oxo-2’-deoxyguanosine (8-oxo-dGuo) and F2a-isoprostane (8-isoprostane).
Timepoint [25] 332623 0
Baseline and week 16
Secondary outcome [26] 332624 0
Nitrogen balance: urinary nitrogen and urine creatinine (from 24 h urine collection).
Timepoint [26] 332624 0
Baseline and week 16
Secondary outcome [27] 332625 0
Quality of life will be assessed using the SF-36 questionnaire
Timepoint [27] 332625 0
Baseline and week 16
Secondary outcome [28] 332630 0
Routine biochemical markers: full blood count, serum creatinine, eGFR and calcium.
Timepoint [28] 332630 0
Baseline and week 16
Secondary outcome [29] 332707 0
Muscle cross-sectional area at the mid-thigh (50% site) and calf (66% site) will be assessed by peripheral QCT (pQCT).
Timepoint [29] 332707 0
Baseline and week 16
Secondary outcome [30] 332708 0
Total body and regional (legs and arms) fat mass and percentage body fat will be measured by dual energy X-ray absorptiometry (DXA).
Timepoint [30] 332708 0
Baseline and week 16

Eligibility
Key inclusion criteria
Relatively sedentary, healthy, community-dwelling women aged 45-65 years with a BMI 17-40 and not engaged in any regular physical activity over the past 6 months (>150 min/week), including resistance training >1 week.
Minimum age
45 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded based on the following: 1) BMI <17 or >40kg/m2, 2) daily step count >7500 per day, or 7501-9000 with <9 daily hours of sedentary time, 3) Previous negative reaction or allergies to milk, dairy proteins, fish collagen, rice, soy lecithin, sweeteners (sucralose, Ace K), vanillin, vitamin D, calcium, magnesium or zinc, 4) Moderate or high level physical activity over the past 6 months (>150 minutes moderate-vigorous physical activity) , 5) Any sustained form of resistance or strength training or regular physical activity (>1 session per week) for either leisure or occupation in the past 12 months, 6) Calcium intake of > 900 mg/day, 7) Use of calcium fortified foods such as biscuits or juice, vitamin D and multivitamin supplements on a regular basis; use of anti-acids containing calcium on a regular basis; bone/joint supplements glucosamine and chondroitin; magnesium supplements (if unable to stop for 4 weeks prior to entering the trial) or protein supplements, 8) Self-reported diagnosed osteoporosis or any low-trauma fracture in the past 12 months, such as hip, spine or wrist fractures, 9) Any fixations (i.e. spine or femoral rods, hip replacements) that would limit participation in the exercise program, 10) Current use of oral hormone replacement therapy, or within previous 12 months, 11) Pregnant, planning to become pregnant, or currently breastfeeding, 12) Self-reported renal disease. [note: Glomerular filtration rate (eGRF) <45ml/min/ 1.73m2, 13) Regular (>3 times per week) anti-inflammatory use over the past 3 months (including aspirin, ibuprofen, omega 3 supplements/fish oils), 14) Rheumatoid arthritis, 15) Self-reported cardiovascular disease (CVD), including heart disease as indicated by the ESSA screening tool or peripheral vascular disease that would limit participation in an exercise program, 16) Current use of any diuretic medication, 17) Metabolic bone disease (including osteomalacia, osteogenesis imperfect and Paget’s disease); also current use of bisphosphonates or during 12 months prior, 18) Endocrine disorders (including hyper- or hypothyroidism (if unstable for past 3 months), parathyroid disease, diabetes mellitus and Cushing’s syndrome), 19) Current (or past 6 months) cancer (including cervical, ovarian, uterine, breast, liver and of the gastrointestinal system), 20) Other medical conditions impacting on digestion, including diseases of the GI tract (eg. Crohn’s Disease, Ulcerative Colitis, Coeliac), or previous bariatric surgery, or liver cirrhosis, 21) Any chronic muscle disease, disorder or injury, not ambulatory, or any injury that would limit participation in the exercise program, 22) Asthma that is not controlled, or other chronic respiratory disease, 26) currently participating in a weight loss program, 27) Failure to obtain GP consent to exercise for those identified using the ESSA Adult Pre-Exercise Screening Tool.

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 then be asked to wear a pedometer for 7 consecutive days to determine their average daily step count. Those who qualify (<7500 steps per day or <9000 steps per day if >9 hours daily sedentary time) will undergo a blood test to determine if their renal function permits them to take part. Randomisation will be at the level of the individual participant (ID) 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) by an independent researcher.
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
Efficacy
Statistical methods / analysis
A sample size of 240 participants in total (120 per treatment arm) was determined using baseline and 12 week follow up data from a cohort of women currently participating in the Fonterra Reduced Steps intervention trial. From a preliminary analysis of covariance (ANCOVA) for the change in ascending stair climb power between baseline and 12 weeks of a subset of the trial data we obtained a standard deviation of 32.0 W. The sample size required to detect a difference between the dairy supplement and placebo of 12.5 W with a significance of 5% and a power of 80% is 104 subjects per treatment arm. To allow for 15% attrition, 240 subjects (120 per treatment arm) will be recruited in total.

Data will be analysed on an intention to treat (ITT) basis. Wherever possible, we will obtain endpoint measures from all withdrawals and include all randomised participants in our final ITT analysis. Analyses will be based primarily on the difference for the change over time from baseline, and in addition, the raw data will be subjected to repeated measures analysis of covariance using mixed models approach. Analysis of (co)variance will be followed by post-hoc comparisons using Tukey’s t test. Data will be log transformed if required to achieve homogeneity of variance. Sensitivity analysis [per protocol] will also be undertaken that only includes those who have achieved at least 90% compliance to nutrition supplement and >=66% (2 of 3 sessions per week) compliance to exercise sessions. Significance is declared if P<0.05. Analyses will be performed using appropriate statistical software such as Stata, SAS, SPSS, or R.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/12/2016
Date of last participant enrolment
Anticipated
2/03/2018
Actual
20/02/2018
Date of last data collection
Anticipated
31/08/2018
Actual
3/08/2018
Sample size
Target
240
Accrual to date
Final
244
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 294859 0
Commercial sector/Industry
Name [1] 294859 0
Fonterra Co-operative Group Ltd
Country [1] 294859 0
New Zealand
Primary sponsor type
University
Name
Deakin University
Address
Institute for Physical Activity and Nutrition Research
Deakin University
221 Burwood Highway,
Burwood, Melbourne
Victoria, Australia 3125
Country
Australia
Secondary sponsor category [1] 293699 0
None
Name [1] 293699 0
Address [1] 293699 0
Country [1] 293699 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296241 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 296241 0
Human Research Ethics
Deakin Research Integrity
Deakin University
221 Burwood Highway
Burwood
Victoria 3125
Ethics committee country [1] 296241 0
Australia
Date submitted for ethics approval [1] 296241 0
Approval date [1] 296241 0
19/10/2016
Ethics approval number [1] 296241 0
2016-300

Summary
Brief summary
This research project will investigate the effect of a dairy-derived nutritional supplement on physical health, mobility and well-being when combined with a physical activity program in 45-65 year-old women identified as habitually sedentary. The project has been designed to determine whether supplementation augments the positive response to a healthy lifestyle that includes moderate-level physical activity, and therefore whether supplementation is a beneficial addition to a healthy, active lifestyle. This is a 4-month randomised controlled trial in which 240 healthy, sedentary women will be randomised to receive: 1) a Fortified Milk Product (FMP) containing addition protein, vitamin D and calcium or a Non-Fortified drink (NFD). All women will also be asked to undertake a supervised gym-based exercise program twice a week under the supervision of accredited exercise trainers and one home-based training session. The multimodal exercise program will consist of strength, mobility and balance/functional training. Participants will undergo testing at baseline and after completion of the intervention (week 16) in the clinical lab at Deakin University. The main outcome for the study is functional muscle power, Secondary outcomes include: muscle strength, function, mobility and balance, body composition, cardiovascular health (blood pressure), circulating bone, cartilage, inflammatory and hormonal markers and perceptions of health, Dietary and physical activity habits will also be assessed. This study is important as the findings will underpin more precise exercise and nutrition guidelines for the prevention (and management) of age-related loss in muscle health and function in sedentary middle-aged adults, along with the ongoing refinement of community-based initiatives for the management of these age-related changes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70018 0
Prof Robin Daly
Address 70018 0
Deakin University
Institute for Physical Activity and Nutrition
221 Burwood Highway,
Burwood, Melbourne
Victoria, Australia 3125
Country 70018 0
Australia
Phone 70018 0
+61 3 9244 6040
Fax 70018 0
Email 70018 0
rmdaly@deakin.edu.au
Contact person for public queries
Name 70019 0
Jenny Gianoudis
Address 70019 0
Deakin University
Institute for Physical Activity and Nutrition
221 Burwood Highway,
Burwood, Melbourne
Victoria, Australia 3125
Country 70019 0
Australia
Phone 70019 0
+61 3 9244 6243
Fax 70019 0
Email 70019 0
j.gianoudis@deakin.edu.au
Contact person for scientific queries
Name 70020 0
Robin Daly
Address 70020 0
Deakin University
Institute for Physical Activity and Nutrition
221 Burwood Highway,
Burwood, Melbourne
Victoria, Australia 3125
Country 70020 0
Australia
Phone 70020 0
+61 3 9244 6040
Fax 70020 0
Email 70020 0
rmdaly@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Approval was not originally sought nor granted from our human research ethics committee.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1997Ethical approval    371740-(Uploaded-05-05-2019-10-53-51)-Study-related document.pdf



Results publications and other study-related documents

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