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Trial registered on ANZCTR
Registration number
ACTRN12614001197628
Ethics application status
Approved
Date submitted
3/11/2014
Date registered
14/11/2014
Date last updated
8/01/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Can protein improve glucose tolerance in older adults with type-2 diabetes??
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Scientific title
Can protein supplementation combined with a 14 week exercise program improve glucose tolerance in older adults with type-2 diabetes?
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Secondary ID [1]
285590
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none
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-insulin dependent type-2 diabetes
293430
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Condition category
Condition code
Metabolic and Endocrine
293704
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants will be randomly allocated to 1 of 3 dietary supplementation groups: 1) wool derived protein, 2) whey protein, or 3) placebo. The study duration will be 17 weeks, which includes an initial two testing weeks, 14 weeks of exercise and protein supplementation co-intervention and a final testing week.. For the 2 week familiarisation, all participants will consume the placebo. The supplement will only be consumed during weekdays, to coincide with the exercise sessions.
Supplement: will be delivered in the form of health bars and capsules, to be consumed 2 times per day (post-exercise, 1 hour prior to bedtime), separated by at least 3 hours. The total daily protein dose in each treatment arm will be 40 gram: a) 17 g KDP+23 g whey, b) 40 g whey, or c) placebo - no added protein. The placebo bars will have the supplemental protein energy content replaced with gluten free flour and refined carbohydrate (maltodextrin, glucose) and fat to match energy and minimize protein content.
Exercise: Exercise Physiologists will supervise 5 days/week intermittent high-intensity mixed-mode, group-based exercise program designed to achieve a fixed-rate 2% gain in exercise load/week. Each training session will be approximately 60 minutes in duration, including: a. Warm-up:10 min light cardio machine exercise and stretching b. Days 1, 2, 4, 5: aerobic (stationary cycle) exercise, comprising a mix of continuous exercise and anaerobic intervals (70-90% of peak power and recovery at 40-50% of peak power). Exercise intensity will be standardised by having all sessions conducted on calibrated ergometers c. Day 3: standardised circuit resistance training (10-30% of the exercise 1 repetition maximum) emphasising the legs d. Cool-down: 5-10 minutes of stretching to cool down Subjects will be required to attend a minimum of 60 sessions over the 14 weeks, and will be provided with the opportunity to complete any missed sessions on weekends.
To ensure adherence to exercise the participants will be supervised. The participants will be required to complete a 3-day dietary recall each time they visit the laboratory for testing, and a text message will be sent to remind the participant to consume the evening dose.
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Intervention code [1]
290540
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Treatment: Other
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Comparator / control treatment
The control bars will have the supplemental protein energy content replaced with by refined carbohydrate (maltodextrin, glucose) and fat to match energy. The control group will be prescribed identical exercise. The only difference between groups is the allotment of protein or placebo
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Whole-body glucose disposal rate during hyperinsulinemic euglycaemic clamp
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Assessment method [1]
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Timepoint [1]
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Weeks 2 and 16
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Secondary outcome [1]
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GLUT4 density and sarcolemmal translocation using differential centrifugation and immunoblot or ELISA, immunoflurochemistry. Skeletal muscle tissue harvested will be from the vastus lateralis.
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Assessment method [1]
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Timepoint [1]
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Weeks 2 and 16
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Secondary outcome [2]
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Insulin-stimulated skeletal muscle (vastus lateralis) mircovascular blood flow, assessed using near-infrared spectroscopy during the hyperinsulinemic euglycaemic clamp
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Assessment method [2]
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Timepoint [2]
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Weeks 2 and 16
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Secondary outcome [3]
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Mitochondrial capacity of the vastus lateralis muscle, assessed using near-infrared spectroscopy
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Assessment method [3]
311208
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Timepoint [3]
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Weeks 2 and 16
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Secondary outcome [4]
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contraction-mediated skeletal muscle (vastus lateralis) microvascular blood flow, assessed using near-infrared spectroscopy during leg-kicking exercise
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Assessment method [4]
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Timepoint [4]
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Weeks 2 and 16
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Secondary outcome [5]
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Blood cholesterol, triglycerides, fasting glucose/insulin, Hb1Ac, alkaline phosphatase, total protein
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Assessment method [5]
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Timepoint [5]
311210
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Weeks 2, 5, 8, 12, 17
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Secondary outcome [6]
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Metabolomics (urine)
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Assessment method [6]
311211
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Timepoint [6]
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Weeks 2, 5, 8, 12, 17
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Secondary outcome [7]
311212
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Daily physical activity, assessed over 7 day using accelerometry
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Assessment method [7]
311212
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Timepoint [7]
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Weeks 1 and 15
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Secondary outcome [8]
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Functional health and well-being via psychometric assessment using
SF36 and DASS
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Assessment method [8]
311213
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Timepoint [8]
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Weeks 2 and 16
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Secondary outcome [9]
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Body composition, using anthropometry and bio-impedance analysis
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Assessment method [9]
311214
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Timepoint [9]
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Weeks 2, 5, 8, 12, 17
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Secondary outcome [10]
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Sleep behaviour, assessed over 7 day using accelerometry
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Assessment method [10]
311319
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Timepoint [10]
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Weeks 2 and 16
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Secondary outcome [11]
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Skeletal muscle capillary density by light microscopy. Skeletal muscle tissue harvested will be from the vastus lateralis.
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Assessment method [11]
311321
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Timepoint [11]
311321
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Weeks 2 and 16
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Secondary outcome [12]
311322
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Mitochondrial metabolic function will be gauged via citrate synthase and cytochrome oxidase IV activity using ELISA. Skeletal muscle tissue harvested will be from the vastus lateralis.
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Assessment method [12]
311322
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Timepoint [12]
311322
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Weeks 2 and 16
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Secondary outcome [13]
311323
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Tissue fibrosis plasticity by endomyosium/myofibril area using light microscopy. Skeletal muscle tissue harvested will be from the vastus lateralis.
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Assessment method [13]
311323
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Timepoint [13]
311323
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Weeks 2 and 16
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Secondary outcome [14]
311324
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phosphorylation status of insulin signalling pathway (PI3K, AS160 on multiple phosphorylation sites) using immunoblot and immunoflurochemistry. Skeletal muscle tissue harvested will be from the vastus lateralis.
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Assessment method [14]
311324
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Timepoint [14]
311324
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Weeks 2 and 16
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Secondary outcome [15]
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gene and protein expression using RT-PCR, transcriptome, proteome and associated molecular methods. Skeletal muscle tissue harvested will be from the vastus lateralis.
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Assessment method [15]
311326
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Timepoint [15]
311326
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Weeks 2 and 16
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Secondary outcome [16]
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anti-oxidant biology (e.g. glutathione, glutathione peroxidase pathways) using biochemical methods. Skeletal muscle tissue harvested will be from the vastus lateralis.
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Assessment method [16]
311327
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Timepoint [16]
311327
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Weeks 2 and 16
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Secondary outcome [17]
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Carotid arterial stiffness. Measured using B-mode ultrasound
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Assessment method [17]
321333
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Timepoint [17]
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Weeks 2, 5, 8, 12, 17
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Secondary outcome [18]
321334
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maximal oxygen uptake via indirect calorimetry using an incremental cycle test to exhaustion
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Assessment method [18]
321334
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Timepoint [18]
321334
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Weeks 2 and 16
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Secondary outcome [19]
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isokinetic leg strength on a Biodex dynamometer
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Assessment method [19]
321335
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Timepoint [19]
321335
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Weeks 2 and 16
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Secondary outcome [20]
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isometric leg strength on a Biodex dynamometer
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Assessment method [20]
321336
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Timepoint [20]
321336
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Weeks 2 and 16
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Secondary outcome [21]
321337
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dynamic leg strength. Tested as 1RM on a leg press
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Assessment method [21]
321337
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Timepoint [21]
321337
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Weeks 2 and 16
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Eligibility
Key inclusion criteria
Thirty-six men and women with non-insulin dependent Type-2 diabetics (diagnosed for a minimum of 1 year), aged 35-70, BMI 25-40, HbA1c >48 mmol/mol, stable weight and not having participated in regular exercise in the past 6 months
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Minimum age
35
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria will include; use of beta-blockers, moderate to severe retinopathy, nephropathy and neuropathy, history of cerebrovascular or cardiovascular diseases, current smoker or having smoked 6 months prior.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited through advertising and through medical centres in Wellington NZ, based upon database records identifying them as meeting the eligibility criteria. After baseline testing, a researcher not involved in the study will randomly allocate participants to treatment and control groups.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each sex will be allocated into the 3 conditions by way of minimisation to reduce the differences between the group means in: baseline glucose clearance rate being the primary clinical defining parameter; peak power on a cycle ergometer as the secondary and fasting baseline glucose concentration as the third parameter.
The process will be completed using an Excel spreadsheet (not using sealed envelopes).
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
The between group effect of treatment will be analysed using mixed linear models via the Proc Mixed utility in SAS (SAS, Cary, NC). Fixed effects within the models will be group (treatment) and time. Random effects (covariance matrix) will be subject, treatment; additional random effects may be added following evaluation of other sources of variability. The baseline values will be added as a covariate to adjust for between-subject variability. Parametric data will be log-transformed prior to analysis, which allows for changes to be expressed as percents and manages heteroscedasticity to adjust residuals to normally-distributed data. Clinical inference and inference to mechanisms outcomes will be via the method of magnitude-based inference.
Sample size estimate was based upon the primary outcome, glucose infusion rate (GIR = glucose disposal rate or the measure of insulin sensitivity). The rationale and calculations are as follows: the test-retest measures for GIR values reported by Defronzo et al and equations for statistical superiority reported in Zhong. The minimum meaningful effect size was set at 23%, a statistically significant outcome following 3 months of diabetic medication. GIR has not been measured following chronic amino acid supplementation, but improvements in HbA1c, fasting and postprandial blood glucose that were seen in T2DM participants following 8 weeks of supplementation, exceeded improvements documented in another study comparing the effect of 3 months treatment with hypoglycaemic medication in poorly controlled diabetes. In that study GIR improved by 23%. To achieve power of 0.80, statistical significance p<.05, and a minimum effect of 23% each group requires 12 participants, which accounts for potential drop-outs.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
27/01/2016
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Actual
27/01/2016
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Date of last participant enrolment
Anticipated
1/05/2017
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Actual
24/01/2017
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Date of last data collection
Anticipated
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Actual
24/05/2017
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Sample size
Target
36
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Accrual to date
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Final
42
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Recruitment outside Australia
Country [1]
6448
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New Zealand
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State/province [1]
6448
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Wellington
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Ministry of Business Innovation and Employment
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Address [1]
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15 Stout Street, Wellington 6011
PO Box 1473, Wellington 6140
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Country [1]
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New Zealand
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Primary sponsor type
University
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Name
Massey University
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Address
63 Wallace St
Mt Cook, Wellington
6021
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
288895
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Country [1]
288895
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Health and Disability Ethics Committee
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Ethics committee address [1]
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Ministry of Health No 1 The Terrace PO Box 5013 Wellington Central 6011
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Ethics committee country [1]
291893
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New Zealand
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Date submitted for ethics approval [1]
291893
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13/11/2014
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Approval date [1]
291893
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15/12/2014
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Ethics approval number [1]
291893
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14/CEN/194
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Summary
Brief summary
There has been a recent growing interest in the use of protein supplementation in type 2 diabetes (T2DM) therapy. Dietary amino acids are potent stimulators of vascular and skeletal muscle adaptations that have been associated with improved cardiovascular health and metabolic flexibility. Previous studies have typically derived these dietary amino acids from dairy sources; alternatively, keratin- derived protein (KDP) is uniquely rich in the amino acid cysteine and has high levels of selenium — both key components in glutathione, a critical agent in cellular antioxidant processes. Preliminary findings suggest that KDP supplementation may aid the attenuation of oxidative stress in diseased (e.g. T2DM) skeletal muscle leading to attenuation in muscle-degradative stress and fibrosis. Therefore, the current study will determine whether chronic KDP supplementation enhances the effects of 12 weeks exercise training on systemic glucose disposal and insulin signalling in middle-aged adults with T2DM. The findings may provide a new simple and practical direction for improving diabetic rehabilitation.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Lee Stoner
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Address
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School of Sport and Exercise, College of Health, Massey University 63 Wallace St Mt Cook, Wellington, 6021
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Country
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New Zealand
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Phone
52478
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+6421817878
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Fax
52478
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Email
52478
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dr.l.stoner@gmail.com
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Contact person for public queries
Name
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Martin Gram
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Address
52479
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School of Sport and Exercise, College of Health, Massey University 63 Wallace St Mt Cook, Wellington, 6021
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Country
52479
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New Zealand
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Phone
52479
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+64221692343
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Fax
52479
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Email
52479
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m.gram@massey.ac.nz
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Contact person for scientific queries
Name
52480
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Martin Gram
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Address
52480
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School of Sport and Exercise, College of Health, Massey University 63 Wallace St Mt Cook, Wellington, 6021
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Country
52480
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New Zealand
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Phone
52480
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+64221692343
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Fax
52480
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Email
52480
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m.gram@massey.ac.nz
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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
Source
Title
Year of Publication
DOI
Embase
Effects of whey protein on skeletal muscle microvascular and mitochondrial plasticity following 10 weeks of exercise training in men with type 2 diabetes.
2021
https://dx.doi.org/10.1139/apnm-2020-0943
Embase
Changes to insulin sensitivity in glucose clearance systems and redox following dietary supplementation with a novel cysteine-rich protein: A pilot randomized controlled trial in humans with type-2 diabetes.
2023
https://dx.doi.org/10.1016/j.redox.2023.102918
N.B. These documents automatically identified may not have been verified by the study sponsor.
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