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Trial registered on ANZCTR


Registration number
ACTRN12616000310460
Ethics application status
Approved
Date submitted
25/02/2016
Date registered
9/03/2016
Date last updated
14/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimal Nutrition in the Elderly: High Protein Diets for Muscular Metabolic, and Microbiome Health
Scientific title
The effects of 10 weeks of high or low protein intake on muscular strength, metabolism and faecal microbiome in elderly men
Secondary ID [1] 288619 0
NIL
Universal Trial Number (UTN)
U1111­1176­5813 
Trial acronym
OptiMuM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia 297773 0
Condition category
Condition code
Diet and Nutrition 297958 297958 0 0
Other diet and nutrition disorders
Musculoskeletal 298102 298102 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will consume a controlled diet provided by the experimenters for 10 weeks. The diet will provide 1.6 g/kg/day of protein and will meet energy needs for each participant based on the Harris-Benedict equation. The diet will also consist of approximately 30% fat and 50% carbohydrate. Participants will be asked to record any food not consumed in a food diary.
Intervention code [1] 294023 0
Lifestyle
Intervention code [2] 294140 0
Prevention
Intervention code [3] 294141 0
Treatment: Other
Comparator / control treatment
Participants will consume a controlled diet provided by the experimenters for 10 weeks. The diet will provide 0.8 g/kg/day of protein and will meet energy needs for each participant based on the Harris-Benedict equation. The diet will also consist of approximately 30% fat and 60% carbohydrate. Participants will be asked to record any food not consumed in a food diary.
Control group
Dose comparison

Outcomes
Primary outcome [1] 297475 0
Isometric knee extension strength measured on a Biodex dynamometer
Timepoint [1] 297475 0
Baseline, post intervention (10 week)
Primary outcome [2] 297476 0
lean body mass measured with DXA
Timepoint [2] 297476 0
Baseline, post intervention (10 weeks)
Primary outcome [3] 297477 0
Insulin sensitivity measured by oral glucose tolerance test
Timepoint [3] 297477 0
Baseline, post intervention (10 week)
Secondary outcome [1] 321151 0
Thigh muscle cross sectional area as measured by pqCT
Timepoint [1] 321151 0
Baseline, post intervention (10 week)
Secondary outcome [2] 321169 0
Short physical performance battery score
Timepoint [2] 321169 0
Baseline, post intervention (10 week)
Secondary outcome [3] 321170 0
quality of life assessed using the SF-36 Quality of Life Questionnaire
Timepoint [3] 321170 0
Baseline, post intervention (10 week)
Secondary outcome [4] 321171 0
Gut microbiome composition measured with faecal RNA sequencing
Timepoint [4] 321171 0
Baseline, Post intervention (10 week)
Secondary outcome [5] 321172 0
Muscle fibre size measured with a muscle biopsy
Timepoint [5] 321172 0
Baseline, Post intervention (10 week)

Eligibility
Key inclusion criteria
*Healthy community dwellers (activities of daily living preformed unassisted)
*BMI (18-35 kg/m2)
*Sedentary to moderately active (structured activity of less than 4 hours per week)
*No history of gastrointestinal disease or disturbance, or antibiotics use in the previous 3 months, or probiotic use in the preceding one month. Normal bowel frequency (minimum once every 2 days, maximum 3 times per day)
Minimum age
70 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
*Receiving dietetic intervention or prescribed dietary supplements in the last month, including calcium and fish oil.
*Receiving palliative care
*History of alcohol abuse
*Smoking
*Participation in an investigational drug evaluation
*On medications which may affect the muscle: however, ACE inhibitors, statins and calcium channel blockers will be allowed.
*Advanced organic diseases: cardiac illness; myocardial infarction; thrombophlebitis; cerebrovascular disease
*Major systemic disease diagnosed or active within the previous 20 years (e.g. cancer, rheumatoid arthritis)
*Osteoarthritis, classified by inability to perform maximal contractions of upper and lower limbs without pain
*Acute febrile illness within the previous 6 months
*Metabolic disease (e.g. diabetes, obesity, thyroid disease)
*Meat or dairy allergy, vegetarian

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)
Allocation is concealed using a lock spreedsheet
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomization sequence was generated with Random.org
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
Two way ANOVA with diet as a between subject factor and time as a within subject factor will be used. A total of 30 subjects with 15 subjects each in the 2 treatment arms will be required to achieve a power of 80% and a significance of 5% for the comparison between treatment and control arms. These calculations are based on the variance in appendicular muscle mass (as measured by DXA) from (Gregorio, et al., 2014), effect size was also based on an extrapolation of these data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7616 0
New Zealand
State/province [1] 7616 0
Auckland

Funding & Sponsors
Funding source category [1] 292982 0
Government body
Name [1] 292982 0
Ministry of Business, Innovation and Employment
Address [1] 292982 0
15 Stout Street, Wellington 6011
PO Box 1473, Wellington 6140
New Zealand
Country [1] 292982 0
New Zealand
Primary sponsor type
University
Name
University Of Auckland
Address
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 291752 0
None
Name [1] 291752 0
NIL
Address [1] 291752 0
NIL
Country [1] 291752 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294491 0
Health and Dissablity Ethics Committees (southern)
Ethics committee address [1] 294491 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington
6011
Ethics committee country [1] 294491 0
New Zealand
Date submitted for ethics approval [1] 294491 0
19/11/2015
Approval date [1] 294491 0
24/02/2016
Ethics approval number [1] 294491 0
15/STH/236

Summary
Brief summary
40 healthy men age 70+ years old will be randomized to consume a weight maintenance diet containing either 0.8 or 1.6 g/kg/day of protein for 10 weeks. Muscle size, strength, lean body mass, physical function (SPPB and timed up and go), insulin sensitivity and gut microbiome composition will be measured before and after the 10 week dietary intervention period. Muscle fibre size will be measured via muscle biopsies taken before and after the intervention period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63886 0
Prof David Cameron-Smith
Address 63886 0
Liggins Institute
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
New Zealand
Country 63886 0
New Zealand
Phone 63886 0
+64 9 923 1336
Fax 63886 0
Email 63886 0
d.cameron-smith@auckland.ac.nz
Contact person for public queries
Name 63887 0
Dr Cameron Mitchell
Address 63887 0
Liggins Institute
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
New Zealand
Country 63887 0
New Zealand
Phone 63887 0
+64 9 923 6606
Fax 63887 0
Email 63887 0
cameron.mitchell@auckland.ac.nz
Contact person for scientific queries
Name 63888 0
Dr Cameron Mitchell
Address 63888 0
Liggins Institute
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
New Zealand
Country 63888 0
New Zealand
Phone 63888 0
+64 9 923 6606
Fax 63888 0
Email 63888 0
cameron.mitchell@auckland.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary