Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000008729
Ethics application status
Approved
Date submitted
19/12/2012
Date registered
4/01/2013
Date last updated
10/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of long term consumption of Australian pork for weight loss and weight maintenance on cardiometabolic health, food cravings and cognition and psychological wellbeing in individuals with type 2 diabetes.
Scientific title
Diet and Lifestyle interventions for glycemic control, cardiometabolic and cognitive health in type 2 diabetes.
Secondary ID [1] 281544 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 287809 0
Overweight and Obese 287810 0
Condition category
Condition code
Diet and Nutrition 288160 288160 0 0
Obesity
Diet and Nutrition 288161 288161 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 288412 288412 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High Protein/Low Carbohydrate diet (containing 30% total dietary energy from protein) for 6 months, consisting of an Energy Restriction (weight loss) phase of 3 months, followed by an Energy Balance (weight maintenance) phase of 3 months. Combined with moderately intense aerobic exercise.

The dietary pattern will be prepared in accordance with the Australian Guide to Healthy Eating and will be a balanced diet consisting of all food groups.
30% Dietary energy will come from protein. Predomiant protein sources will be meat (pork, beef, chicken) as well as fish, dairy and plant sources (legumes and pulses)

To acheive weight loss, dietary energy will be restircted by 20-30% (approximately 2000-4000KJ per day) and each individual will have their diet tailored by a dietician based on energy requirements, gender and BMI.
After 3months weight loss, each individuals dietary energy will be adjusted by the dietician to maintain the weight loss to date for a further 3months.

Moderately intense excerise will be required 5x per week for 30minutes. Walking, Jogging or Running depending on individual choice will be undertaken. Volunteers may conduct their activity alone or join walking groups that will be offered around the Adelaide CBD. Excercise will be perceptually-regulated at a Rating of Perceived Exertion (RPE-13) that is perceived to be "somewhat hard" which results in moderately instese aerobic exercise.
Intervention code [1] 286059 0
Lifestyle
Comparator / control treatment
Low Protein/High Carbohydrate diet (containing 20% total dietary energy from protein) for 6 months, consisting of an Energy Restriction (weight loss) phase of 3 months, followed by an Energy Balance (weight maintenance) phase of 3 months. Combined with moderately intense aerobic exercise.

The dietary pattern will be prepared in accordance with the Australian Guide to Healthy Eating and will be a balanced diet consisting of all food groups.
20% Dietary energy will come from protein. Predomiant protein sources will be meat (pork, beef, chicken) as well as fish, dairy and plant sources (legumes and pulses) in reduced quantities compared to the high protein diet.
Additional sources of carbohydrate will be supplied as pasta, rice, potato and increased quantities of breads compared to the high protein diet.

To acheive weight loss, dietary energy will be restircted by 20-30% (approximately 2000-4000KJ per day) and each individual will have their diet tailored by a dietician based on energy requirements, gender and BMI.
After 3months weight loss, each individuals dietary energy will be adjusted by the dietician to maintain the weight loss to date for a further 3months.

Moderately intense excerise will be required 5x per week for 30minutes. Walking, Jogging or Running depending on individual choice will be undertaken. Volunteers may conduct their activity alone or join walking groups that will be offered around the Adelaide CBD. Excercise will be perceptually-regulated at a Rating of Perceived Exertion (RPE-13) that is perceived to be "somewhat hard" which results in moderately instese aerobic exercise.
Control group
Active

Outcomes
Primary outcome [1] 288365 0
HbA1c (glycosylated haemoglobin)
levels in whole blood.
Timepoint [1] 288365 0
0 months, 3months, 6 months
Secondary outcome [1] 299966 0
Body Weight (kg)
Measured on electronic scales
Timepoint [1] 299966 0
0 months, 3months, 6 months
Secondary outcome [2] 299967 0
Percentage body fat
Measured by dual x-ray absorptiometry (DEXA)
Timepoint [2] 299967 0
0 months, 3months, 6 months
Secondary outcome [3] 299968 0
Blood Lipids; Total cholesterol, HDL cholesterol, Trigylceride, and LDL cholesterol
Timepoint [3] 299968 0
0 months, 3months, 6 months
Secondary outcome [4] 299969 0
Blood pressure
Measured by automated oscillometry while seated
Timepoint [4] 299969 0
0 months, 3months, 6 months
Secondary outcome [5] 299970 0
Insulin and Glucose levels in blood
Timepoint [5] 299970 0
0 months, 3months, 6 months
Secondary outcome [6] 299971 0
C-reactive protein levels in blood
Timepoint [6] 299971 0
0 months, 3months, 6 months
Secondary outcome [7] 299972 0
Food Cravings
as assessed by the Food Cravings Inventory questionnaire
Timepoint [7] 299972 0
0 months, 3months, 6 months
Secondary outcome [8] 299973 0
Cognitive Function (executive function)

The cognitive battery consists of the following tests: Visual Spatial Learning Test, Visual Verbal Learning Test, Corsi Block Tapping Test, Tower of Hanoi, Grooved Pegboard, Psychomotor Test, Source Monitoring Test and Paragraph Recall. These tests will be administered on computer using E-Prime software, apart from the VSLT and Grooved Pegboard which will be administered by the experimenter by hand.
Timepoint [8] 299973 0
0 months, 3months, 6 months
Secondary outcome [9] 299974 0
Psychological Wellbeing and Quality of Life

as assessed by the following questionnaires:
Perceived Stress Scale (PSS-10),
Leeds Sleep Evaluation Questionnaire (LSEQ),
QualityMetric’s SF-36 (assessing physical, mental and social health),
Diabetes Management questionnaire (Diabetes-39),
Quality of life questionnaires (PAID)
Timepoint [9] 299974 0
0 months, 3months, 6 months
Secondary outcome [10] 299985 0
Waist Circumference
Measured according to the International Standards for Anthropometric Assessment by tape measure.
Timepoint [10] 299985 0
0 months, 3months, 6 months
Secondary outcome [11] 300234 0
Rate of Heart Rate increase

Recorded by personal heart rate monitor during a 5minute sub-maximal, perceptually-regulated graded treadmill exercise test
Timepoint [11] 300234 0
0 months, 3 months, 6 months

Eligibility
Key inclusion criteria
Poorly controlled type 2 diabetes (with a HbA1c level between 7-10%); overweight or obese (BMI, 25 kg/m2 and above); omnivorous; English as a First Language (different cognitive processes are applied when learning words from a non-native language)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects who report one of the following: known proteinuria, malignancy; liver, kidney, cardiovascular, respiratory, or gastrointestinal disease; uncontrolled hypertension; previous stroke; pregnancy or lactating; smoker (or smoking in the last 6months); musculoskeletal injury or joint or peripheral vascular disease sufficient to impede exercise; use of appetite suppressants or Orlistat (Xenical); retinopathy; inability to consume a high meat protein diet for 6 months; actively undertaking a weight loss program or report their weight is greater than 135kg (exceeds the capability for DEXA scanning to assess body composition); unable to participate in the trial for 6 months; taking medications for, or had a history of head/brain, neurological or psychiatric conditions, scores of <13 on the DemTect indicating mild cognitive impairment or dementia will be excluded.

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)
Eligibility will be determined by screening questionnaire as well as assesment of blood HbA1c levels.
An independant holder of the randomisation schedule will perform treatment allocation without contact with the volunteers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation by the process of minimisation based on age, gender and BMI
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
11/01/2013
Actual
23/01/2013
Date of last participant enrolment
Anticipated
1/06/2013
Actual
1/07/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 286326 0
Government body
Name [1] 286326 0
Pork CRC
Country [1] 286326 0
Australia
Primary sponsor type
Individual
Name
Prof Jon Buckley (Centre Director)
Address
GPO Box 2471, Adelaide, SA, 5001
Country
Australia
Secondary sponsor category [1] 285115 0
Individual
Name [1] 285115 0
Dr Karen Murphy (Chief Investigator)
Address [1] 285115 0
GPO Box 2471, Adelaide, SA, 5001
Country [1] 285115 0
Australia
Secondary sponsor category [2] 285119 0
Individual
Name [2] 285119 0
Prof Manny Noakes
Address [2] 285119 0
CSIRO Preventative Health, Kintore Ave, Adelaide, SA, 5001
Country [2] 285119 0
Australia
Secondary sponsor category [3] 285120 0
Individual
Name [3] 285120 0
Prof Peter Howe
Address [3] 285120 0
GPO Box 2471, Adelaide, SA, 5001
Country [3] 285120 0
Australia
Secondary sponsor category [4] 285121 0
Individual
Name [4] 285121 0
A/Prof Grant Brinkworth
Address [4] 285121 0
CSIRO Preventative Health, Kintore Ave, Adelaide, SA, 5001
Country [4] 285121 0
Australia
Secondary sponsor category [5] 285122 0
Individual
Name [5] 285122 0
A/Prof Alison Coates
Address [5] 285122 0
GPO Box 2471, Adelaide, SA, 5001
Country [5] 285122 0
Australia
Secondary sponsor category [6] 285123 0
Individual
Name [6] 285123 0
A/Prof Gaynor Parfitt
Address [6] 285123 0
GPO Box 2471, Adelaide, SA, 5001
Country [6] 285123 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288401 0
University of South Australia
Ethics committee address [1] 288401 0
Mawson Lakes Campus, Mawson Lakes Boulevard, Mawson Lakes, 5095, South Australia
Ethics committee country [1] 288401 0
Australia
Date submitted for ethics approval [1] 288401 0
08/10/2012
Approval date [1] 288401 0
18/12/2012
Ethics approval number [1] 288401 0
0000030653

Summary
Brief summary
In a 6 month dietary intervention trial, we aim to compare the effects of an energy restricted low carbohydrate/high protein diet and an energy restricted high carbohydrate/low protein diet with regular moderately intense aerobic exercise on glycemic control in individuals with type 2 diabetes. Assessing weight loss and weight maintenance, cardiometabolic health (blood pressure/cholesterol/C-reactive protein/insulin/glucose), food cravings, cognitive performance, psychological wellbeing and quality of life. We believe the low carbohydrate/high protein diet will give the greatest improvements in these outcomes.
Trial website
Trial related presentations / publications
Watson NA, Dyer KA, Buckley JD, Parfitt G, Coates, AM, Brinkworth GD, Noakes M, Dye L, Chadwick H, Murphy KJ. (2015) A randomised trial comparing low-fat diets differing in carbohydrate and protein ratio, combined with regular moderate intensity exercise, on glycaemic control, cardiometabolic risk factors, food cravings, cognitive function and psychological wellbeing in adults with type 2 diabetes: Study protocol. Contemp Clin Trials 45, 217-225.

Watson NA, Dyer KA, Buckley JD, Parfitt G, Coates, AM, Brinkworth GD, Noakes M, Dye L, Chadwick H, Murphy KJ. (2016) A randomised trial comparing low-fat diets differing in carbohydrate and protein ratio, combined with regular moderate intensity exercise, on glycaemic control, cardiometabolic risk factors, food cravings, cognitive function and psychological wellbeing in adults with type 2 diabetes: Submitted Feb 2016. Nutrients
Public notes

Contacts
Principal investigator
Name 34953 0
Dr Karen Murphy
Address 34953 0
GPO Box 2471, Adelaide, SA 5001
Country 34953 0
Australia
Phone 34953 0
+61 8 83022097
Fax 34953 0
+61 8 83022178
Email 34953 0
karen.murphy@unisa.edu.au
Contact person for public queries
Name 18200 0
Dr Karen Murphy
Address 18200 0
GPO Box 2471, Adelaide, SA 5001
Country 18200 0
Australia
Phone 18200 0
+61 8 83022097
Fax 18200 0
+61 8 83022178
Email 18200 0
karen.murphy@unisa.edu.au
Contact person for scientific queries
Name 9128 0
Prof Jon Buckley
Address 9128 0
GPO Box 2471, Adelaide, SA 5001
Country 9128 0
Australia
Phone 9128 0
+61 8 83022097
Fax 9128 0
+61 8 83022178
Email 9128 0
karen.murphy@unisa.edu.au

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
EmbaseComparison of two low-fat diets, differing in protein and carbohydrate, on psychological wellbeing in adults with obesity and type 2 diabetes: A randomised clinical trial.2018https://dx.doi.org/10.1186/s12937-018-0367-5
EmbaseEffects of low-fat diets differing in protein and carbohydrate content on cardiometabolic risk factors during weight loss and weight maintenance in obese adults with type 2 diabetes.2016https://dx.doi.org/10.3390/nu8050289
EmbaseA randomised trial comparing low-fat diets differing in carbohydrate and protein ratio, combined with regular moderate intensity exercise, on glycaemic control, cardiometabolic risk factors, food cravings, cognitive function and psychological wellbeing in adults with type 2 diabetes: Study protocol.2015https://dx.doi.org/10.1016/j.cct.2015.11.001
N.B. These documents automatically identified may not have been verified by the study sponsor.