Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000592741
Ethics application status
Approved
Date submitted
16/05/2013
Date registered
27/05/2013
Date last updated
23/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Does a High Protein Enriched Drink and Vitamin D Enhance the Health Benefits of Progressive Resistance Training Program in Older Adults with Type 2 Diabetes?
Scientific title
Does a High Protein Enriched Drink and Vitamin D Enhance the Health Benefits of the Lift for Life (Registered Trademark) Resistance Training Program on Glycaemic Control, Body Composition and Cardiometabolic Risk Factors in Older Adults with Type 2 Diabetes?
Secondary ID [1] 282345 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 289253 0
Condition category
Condition code
Metabolic and Endocrine 289241 289241 0 0
Diabetes
Diet and Nutrition 289242 289242 0 0
Other diet and nutrition disorders
Public Health 289243 289243 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 6-month, randomised controlled trial in which participants with type 2 diabetes will participate in a progressive resistance training program (termed Lift for Life) and receive a daily protein enriched drink and vitamin D supplements for 6 months. The Lift for Life program is an individually tailored and supervised group-based community-based program in which participants undertake progressive resistance training twice a week for the first 8 weeks and then three times each week thereafter. Each session will last 45-60 minutes and target all major muscle groups. Participants will perform 3 sets of 8-10 repetitions at a weight that cannot be lifted for more than 8-10 repetitions. Training will be made progressively more challenging by incorporating the principle of progressive overload (increments of 2-10% weekly). All training is supervised by accredited Lift for Life exercise trainers. To increase protein intake and vitamin D status, participants will be asked to consume a protein enriched drink each day that will contain approximately 20 g of protein and take two 1000 IU vitamin D3 capsules daily for the duration of the study. On the training days, participants will also be asked to consume a second protein enriched drink after training. Exercise logs and completed exercise cards regularly checked by the trainers will be used to monitor exercise adherence. Adherence to the drinks will be monitored using a daily calendar and counting any remaining drinks at 3 and 6 months. Compliance to the supplements will be monitored by a capsule count from bottles returned at 3 and 6 months.
Intervention code [1] 286965 0
Lifestyle
Intervention code [2] 286966 0
Treatment: Other
Comparator / control treatment
Participants allocated to the active control group will also undertake the same progressive resistance training program (Lift for Life) as those in the intervention group, but will not receive an energy matched placebo drink or placebo tablets.
Control group
Active

Outcomes
Primary outcome [1] 289507 0
Glycemic control (HbA1c)
Timepoint [1] 289507 0
Baseline, 3 and 6 months
Primary outcome [2] 289508 0
Insulin sensitivity (estimated from the HOMA-2 program)
Timepoint [2] 289508 0
Baseline, 3 and 6 months
Secondary outcome [1] 302651 0
Lean tissue mass (measured by DXA) and muscle cross-sectional area (measured by pQCT)
Timepoint [1] 302651 0
Baseline and 6 months
Secondary outcome [2] 302652 0
Systolic and diastolic blood pressure
Timepoint [2] 302652 0
Baseline and 6 months
Secondary outcome [3] 302653 0
Blood lipids (total cholesterol, HDL- and LDL- cholesterol and triglycerides)
Timepoint [3] 302653 0
Baseline, 3 and 6 months
Secondary outcome [4] 302654 0
Adipokines and inflammatory biomarkers
Timepoint [4] 302654 0
Baseline, 3 and 6 months
Secondary outcome [5] 302655 0
Three repetition maximum leg and back muscle strength will be assessed on an isotonic leg press and seated row machine.
Timepoint [5] 302655 0
Baseline and 6 months
Secondary outcome [6] 302656 0
Fat mass (percent body fat) measured by DXA
Timepoint [6] 302656 0
Baseline and 6 months
Secondary outcome [7] 302657 0
Balance and gait via the 30-sec sit-to-stand, timed-up-and-go (TUG) and four-square step test
Timepoint [7] 302657 0
Baseline and 6 months
Secondary outcome [8] 302658 0
Health related quality of life (SF36v2)
Timepoint [8] 302658 0
Baseline, 3 and 6 months

Eligibility
Key inclusion criteria
Males and females aged 50 to 75 years with established type 2 diabetes, treated with diet alone or oral hypoglycaemic agents (not insulin). All participants enrolled in the study must also have received approval from their local physician to participate in the community-based Lift for Life resistance training program.
Minimum age
50 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded based on the following: 1) glycemic control (HbA1c) >10%; 2) current or prior participation in progressive resistance training (>1 week) or moderate-intensity physical activity >=150 min/week for >3 months; 3) vitamin D and/or calcium supplement use (>500 IU/d and >600 mg/d) in the past 3 months; 4) severe orthopaedic, cardiovascular or respiratory conditions that would preclude participation in an exercise program, or those with absolute contraindications to exercise according to American College of Sports Medicine (ACSM) guidelines; 5) renal impairment (eGFR <45 mL/min/1.73m2) or disease; 6) use of protein supplements; 7) conditions that may affect vitamin D or calcium metabolism; 8) current smoker, or 9) BMI >40 kg/m2.

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 who are eligible and registered to commence participation in the Lift for Life resistance training program will be invited to participate in this study. Participants may be referred to the program from their doctor or may respond to local advertisements about the program. Eligible participants will then be screened further to ensure they fulfill the inclusion criteria for this study. 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 and diabetes treatment (diet or oral hypoglycaemic agents), using a computer-generated random number sequence by an independent researcher not involved in the study. The assignment will be blinded to the investigators involved in all testing so that they will be unaware of the group assignment.
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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Randomised controlled trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All statistical analyses will be conducted on an intention-to-treat basis using Stata (version 11). Wherever possible, we will obtain endpoint measures from all withdrawals and include all randomised subjects in our final ITT analysis. Time, group and group-by-time interactions will be examined using linear mixed regression models. Potential covariates to be included in the model will include: age, sex, race/ethnicity, changes in medication and change in habitual physical activity or diet.

Based on our previous data from progressive resistance training studies in people with type 2 diabetes and work of others that have assessed the independent or combined effects of protein, vitamin D and resistance training on the main outcome measures, we estimate that 168 participants would provide 90% power (P<0.05 two-tailed) to detect a 0.5% absolute difference for the change in HbA1c levels between the groups, assuming a conservative SD of 1.1%. For insulin sensitivity, a sample size of 140 would be required to detect a 0.7 difference for the change in HOMA-2 IR between the groups at a power of 90%, assuming a conservative SD of 1.2. To compensate for a projected 20% drop-out, a total of 202 participants will be recruited into the study and randomised 1:1 to the two groups (101 per group).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/10/2013
Actual
7/02/2014
Date of last participant enrolment
Anticipated
Actual
22/03/2016
Date of last data collection
Anticipated
Actual
22/09/2016
Sample size
Target
202
Accrual to date
Final
198
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 287227 0
Government body
Name [1] 287227 0
National Health and Medical Research Council (NHMRC)
Country [1] 287227 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Centre for Physical Activity and Nutrition Research
221 Burwood Highway,
Burwood, Melbourne, Victoria 3125
Country
Australia
Secondary sponsor category [1] 285982 0
Charities/Societies/Foundations
Name [1] 285982 0
Baker IDI Heart and Diabetes Institute
Address [1] 285982 0
Level 4
99 Commerical Rd, Melbourne, Victoria, 3004
Country [1] 285982 0
Australia
Secondary sponsor category [2] 285983 0
University
Name [2] 285983 0
Curtin University
Address [2] 285983 0
School of Public Health
GPO Box U 1987
Perth WA 6845
Country [2] 285983 0
Australia
Secondary sponsor category [3] 285984 0
Commercial sector/Industry
Name [3] 285984 0
Fitness Australia
Address [3] 285984 0
Level 3, 180 Albert Rd
South Melbourne VIC 3205
Country [3] 285984 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289214 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 289214 0
Human Research Ethics
Deakin Research Integrity
Deakin University
221 Burwood Highway
Burwood
Victoria 3125
Ethics committee country [1] 289214 0
Australia
Date submitted for ethics approval [1] 289214 0
Approval date [1] 289214 0
09/04/2013
Ethics approval number [1] 289214 0
2013-050

Summary
Brief summary
Lifestyle factors such as exercise and diet remains the cornerstone in the management of type 2 diabetes. Progressive resistance training is one mode of exercise that can improve glycaemic control and other metabolic risk factors that contribute to the development of diabetes complications. Whether diet and exercise combined can have added benefits remains unknown. In non-diabetic adults, high protein diets can enhance the benefits of resistance training on muscle mass and strength. There is also evidence that vitamin D deficiency is associated with glucose intolerance and insulin resistance, which can be improved with treatment. This study builds upon our current community-based resistance training program, titled ‘Lift for Life (L4L)’, to examine whether post-exercise ingestion of a protein enriched drink and vitamin D can enhance the benefits of resistance training on glycaemic control, body composition and cardiometabolic health in adults with type 2 diabetes. This study is important as the findings will underpin more precise exercise and nutrition guidelines for the management of glycaemic control and cardiometabolic risk factors in people with type 2 diabetes, along with the ongoing refinement of community-based initiatives for the management of this condition.
Trial website
Trial related presentations / publications
Miller EG, Nowson CA, Dunstan DW, Kerr DA, Solah V, Menzies D, Daly RM. Recruitment of older adults with type 2 diabetes into a community-based exercise and nutrition randomised controlled trial. Trials Sep 26;17(1):467, 2016.

Daly RM, Miller E, Dunstan DW, Nowson C, Kerr D, Solah V, Menzies D. The effects of progressive resistance training combined with a whey-protein drink and vitamin D supplementation on glycaemic control, body composition and cardiometabolic risk factors in older adults with Type 2 diabetes: Study protocol for a randomised controlled trial. Trials 15:431, 2014 DOI: 10.1186/1745-6215-15-431
Public notes

Contacts
Principal investigator
Name 39282 0
Prof Robin Daly
Address 39282 0
Deakin University
Centre for Physical Activity and Nutrition Research
221 Burwood Highway
Burwood, Melbourne, Victoria 3125
Country 39282 0
Australia
Phone 39282 0
+61 3 9244 6040
Fax 39282 0
Email 39282 0
[email protected]
Contact person for public queries
Name 39283 0
Eliza Miller
Address 39283 0
Deakin University
School of Exercise and Nutrition Sciences
221 Burwood Highway
Burwood, Melbourne, Victoria 3125
Country 39283 0
Australia
Phone 39283 0
+61 3 52271100
Fax 39283 0
Email 39283 0
[email protected]
Contact person for scientific queries
Name 39284 0
Robin Daly
Address 39284 0
Deakin University
Centre for Physical Activity and Nutrition Research
221 Burwood Highway
Burwood, Melbourne, Victoria 3125
Country 39284 0
Australia
Phone 39284 0
+61 3 9244 6040
Fax 39284 0
Email 39284 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 progressive resistance training combined with a whey-protein drink and vitamin D supplementation on glycaemic control, body composition and cardiometabolic risk factors in older adults with type 2 diabetes: Study protocol for a randomized controlled trial.2014https://dx.doi.org/10.1186/1745-6215-15-431
EmbaseRecruitment of older adults with type 2 diabetes into a community-based exercise and nutrition randomised controlled trial.2016https://dx.doi.org/10.1186/s13063-016-1589-5
EmbaseEffects of whey protein plus vitamin D supplementation combined with progressive resistance training on glycaemic control, body composition, muscle function and cardiometabolic risk factors in middle-aged and older overweight/obese adults with type 2 diabetes: A 24-week randomized controlled trial.2021https://dx.doi.org/10.1111/dom.14299
N.B. These documents automatically identified may not have been verified by the study sponsor.