Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000223235
Ethics application status
Approved
Date submitted
4/12/2008
Date registered
4/05/2009
Date last updated
24/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Lean red meat with exercise on muscle health in elderly women
Scientific title
The effect of increased consumption of lean read meat with regular exercise on inflammation markers, and muscle health and functional performance in elderly women.
Secondary ID [1] 282397 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Body composition in elderly women 4069 0
Inflammation markers in elderly women 4070 0
Condition category
Condition code
Diet and Nutrition 4276 4276 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The overall duration of the intervention is 16 weeks. Increased dietary protein. Subjects will be supplied with lean red meat to enable them to consume 1.3g/kg/day of protein. This equates to 160g of cooked meat per day, which they will be asked to consume for at least 6 days per week for 16 weeks. Subjects will receive a Vitamin D supplement (1000 IU/day) and will be asked to take this oral tablet daily for 16 weeks. Subjects will be asked to participate in an individually tailored resistance and balance/agility training program administered by a quaified personal trainer twice per week (45-60 minute sessions, 32 sessions in total), as well as participate in one additional unsupervised exercise session (30-60 minutes) per week for 16 weeks, such as walking, cycling or swimming.
Intervention code [1] 3789 0
Behaviour
Intervention code [2] 3790 0
Lifestyle
Comparator / control treatment
Dietary protein intake equivalent to the current estimated average requirement (EAR). Subjects will be supplied with pasta and rice and will be advised to focus on having larger servings of bread, cereals, rice and vegetables and small serves of protein foods: meat, fish to enable them to consume the EAR for protein of 0.75 g/kg/d. Subjects will receive a Vitamin D supplement (1000 International Units (IU)/day) and will be asked to take this oral tablet daily for 16 weeks. Subjects will be asked to participate in an individually tailored resistance and balance/agility training program administered by a quaified personal trainer twice per week (45-60 minute sessions, 32 sessions in total), as well as participate in one additional unsupervised exercise session (30-60 minutes) per week, such as walking, cycling or swimming. The total duration of the control treatment will be 16 weeks.
Control group
Active

Outcomes
Primary outcome [1] 5161 0
Total body and regional (leg and arm) lean tissue mass will be measured by dual energy X-ray absorptiometry (DXA Lunar Prodigy)
Timepoint [1] 5161 0
At baseline and 4 months after completing the intervention or control treatment.
Primary outcome [2] 5162 0
Skeletal muscle cross sectional area measured using peripheral computed tomography (pQCT).
Timepoint [2] 5162 0
Baseline and 4 months after completing the intervention or control treatment.
Primary outcome [3] 5163 0
The following cytokines will be assessed using commercially available Radioimmunoassay (RIA) or Enzyme Linked Immunosorbent Assay (ELISA) kits: interleukin-6 (IL-6), tumor necrosis factor (TNF-a), adiponectin, high sensitivity C-reactive protein (hs-CRP), and interleukin-10 (IL-10).
Timepoint [3] 5163 0
Baseline and 4 months after completing the intervention or control treatment.
Secondary outcome [1] 8685 0
Dynamic balance and strength/power will be assessed using the four square step test (FSST) and 30 sec sit to stand test (STS)
Timepoint [1] 8685 0
Baseline and 4 months after completing the intervention or control treatment.
Secondary outcome [2] 8686 0
Gait will be assessed using the 3-metre times up and go test.
Timepoint [2] 8686 0
Baseline and 4 months after completing the intervention or control treatment.
Secondary outcome [3] 8687 0
Lower limb muscle strength will be assessed using the leg extension machine.
Timepoint [3] 8687 0
Baseline and 4 months after completing the intervention or control treatment.
Secondary outcome [4] 8688 0
The following hormonal parameters: serum insulin-like growth factor-1 (IGF-1), 25-hydroxyvitamin D and parathyroid hormone (PTH) will be assessed by collecting serum blood samples.
Timepoint [4] 8688 0
Baseline, 2 and 4 months. after completing the intervention or control treatment.
Secondary outcome [5] 8689 0
Nutritional status will be assessed by urinary urea, via 24 hour urine collection, and serum concentrations of albumin, folate, vitamin B12 and homocysteine.
Timepoint [5] 8689 0
Baseline, 2 and 4 months after completing the intervention or control treatment.
Secondary outcome [6] 8690 0
Dietary intake will be calculated from 24 hour dietary recalls using Australia specific dietary analysis software (Foodworks, Xyris Software Qld).
Timepoint [6] 8690 0
Baseline, 1, 2, 3 and 4 months after completing the intervention or control treatment.
Secondary outcome [7] 8691 0
Physical activity will be assessed using the (Community Healthy Activities Model Progam for Seniors) CHAMPS physical activity survey.
Timepoint [7] 8691 0
Baseline, 1, 2, 3 and 4 months after completing the intervention or control treatment.
Secondary outcome [8] 8692 0
General health and well being will be assessed using the health-related quality life (SF-36) questionnaire.
Timepoint [8] 8692 0
Baseline and 4 months after completing the intervention or control treatment.
Secondary outcome [9] 302458 0
Hip and spine bone mineral density (BMD) will be assessed using DXA (Lunar Prodigy)
Timepoint [9] 302458 0
Baseline and 4 months after completing the intervention or control treatment.
Secondary outcome [10] 302459 0
Thigh fat cross-sectional area and muscle attenuation measured by pQCT
Timepoint [10] 302459 0
Baseline and 4 months after completing the intervention or control treatment.

Eligibility
Key inclusion criteria
Retired women aged 65 years and over residing in retirement villages within Metropolitan Melbourne and surrounding regions.
Minimum age
65 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who have been involved in resistance exercise and/or engaged in moderate-intensity exercise >150 min/week for >3 months.
Participants with acute or terminal illness, unstable metabolic or cardiovascular disease, diabetes, Body Mass Index (BMI) >40, current or previous weight loss (>5kg) in last 6 months, contradictions to the planned exercise or inability to commit to the 4 month program.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited from retirement villages in Melbourne and surrounding areas. Because the intervention will be conducted within the retirement villages, the participants will be randomised by cluster (e.g. retirement village) to avoid contamination. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by a computer software.
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/01/2009
Actual
4/02/2009
Date of last participant enrolment
Anticipated
Actual
19/07/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4248 0
Commercial sector/Industry
Name [1] 4248 0
Meat and Livestock Australia
Country [1] 4248 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway, Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 3821 0
None
Name [1] 3821 0
Address [1] 3821 0
Country [1] 3821 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6299 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 6299 0
Research Services Deakin University
221 Burwood Highway, Burwood VIC 3125
Ethics committee country [1] 6299 0
Australia
Date submitted for ethics approval [1] 6299 0
Approval date [1] 6299 0
19/11/2008
Ethics approval number [1] 6299 0
EC 181-2008

Summary
Brief summary
The research program will test the hypothesis that increasing dietary protein to at least 1.3 g/kg/d through the consumption of lean red meat on most days of the week, when combined with regular exercise (progressive resistance training), in a vitamin D replete state, can reduce markers of inflammation and enhance muscle mass, strength, power and functional performance in elderly women compared to resistance training alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29198 0
Prof Robin Daly
Address 29198 0
Deakin University
Centre for Physical Activity and Nutrition Research
221 Burwood Highway
Burwood, Melbourne Victoria 3125
Country 29198 0
Australia
Phone 29198 0
+61 3 92446040
Fax 29198 0
Email 29198 0
[email protected]
Contact person for public queries
Name 12355 0
Prof Robin Daly
Address 12355 0
Chair of Nutrition and Ageing
Deakin University
School of Exercise and Nutrition Sciences
221 Burwood Highway
Burwood VIC 3125
Country 12355 0
Australia
Phone 12355 0
+61392446040
Fax 12355 0
Email 12355 0
[email protected]
Contact person for scientific queries
Name 3283 0
Prof Robin Daly
Address 3283 0
Chair of Nutrition and Ageing
Deakin University
School of Exercise and Nutrition Sciences
221 Burwood Highway
Burwood VIC 3125
Country 3283 0
Australia
Phone 3283 0
+61392440640
Fax 3283 0
Email 3283 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
No additional documents have been identified.