Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000475549
Ethics application status
Approved
Date submitted
14/11/2006
Date registered
15/11/2006
Date last updated
15/11/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
High Protein Diets, Weight Loss and Diabetes Study 2007
Scientific title
A 12 week randomised parallel trial comparing 2 different high protein weight loss diets on blood cholesterol levels, blood sugar control and on kidney and cognitive function in Type 2 Diabetes and Obesity
Secondary ID [1] 317 0
Commonwealth Scientific Industrial Research Organisation (CSIRO): AD51A
Universal Trial Number (UTN)
Trial acronym
DACCK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 1450 0
Obesity 1451 0
Condition category
Condition code
Metabolic and Endocrine 1545 1545 0 0
Diabetes
Diet and Nutrition 1546 1546 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 week dietary intervention of daily high protein 31%/high dietary cholesterol 650mg/Fat 29%/Carbohydrate 37% diet for 3 meals per day. Both diets are energy restricted to achieve weight loss.
Intervention code [1] 1447 0
Lifestyle
Comparator / control treatment
12 week dietary intervention of daily high protein 34% /low dietary cholesterol 230mg/fat 26%/Carbohydrate 37% diet for 3 meals per day.
Control group
Active

Outcomes
Primary outcome [1] 2134 0
1. Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL) Total Cholesterol and triglycerides
Timepoint [1] 2134 0
At week 0 and week 12
Primary outcome [2] 2135 0
2. Fasting ApoB
Timepoint [2] 2135 0
At week 0 and week 12
Primary outcome [3] 2136 0
3. Glucose tolerance test (GTT) (0, 2hours)
Timepoint [3] 2136 0
At week 0 and week 12
Primary outcome [4] 2137 0
4. Post prandial glucose using CGMS (36hr)
Timepoint [4] 2137 0
At week 0 and week 12
Primary outcome [5] 2138 0
5. HbA1C
Timepoint [5] 2138 0
At week 0 and week 12
Secondary outcome [1] 3698 0
1. Plasma folate, homocysteine
Timepoint [1] 3698 0
at week 0 and 12
Secondary outcome [2] 3699 0
2. Cognitive function
Timepoint [2] 3699 0
at week 0 and 12
Secondary outcome [3] 3700 0
3. Satiety profiles
Timepoint [3] 3700 0
assessed over a 12 hour period at week 0 and 12
Secondary outcome [4] 3701 0
4. Weight loss (including lean and fat loss as assessed by bioelectrical impedance)
Timepoint [4] 3701 0
at week 0 and 12
Secondary outcome [5] 3702 0
5. Renal function (urinary urea, plasma creatinine and microalbuminuria)
Timepoint [5] 3702 0
at week 0 and 12
Secondary outcome [6] 3703 0
6. Plasma lutein zeaxanthein and other carotenoids
Timepoint [6] 3703 0
at week 0 and 12
Secondary outcome [7] 3704 0
7. Nutrient intakes before and during weight loss
Timepoint [7] 3704 0
at week 0 and 12

Eligibility
Key inclusion criteria
Body Mass Index (BMI) 25-40kg/m2 (this will be calculated for you)• Previously diagnosed Type 2 diabetes as noted on medical questionnaire or as assessed by a fasting blood glucose at screening (>6.1mmol/L).• HbA1C<9% (measured at screening)• Participants must understand the procedures involved and agree to participate in the study by giving full informed, written consent.• No abnormality of clinical significance on medical history (i.e. life-threatening cancer, liver or metabolic disease or cardiovascular problems - unstable angina, previous incidence of myocardial infarction, stroke or heart irregularity).• Not have type 1 diabetes (self reported)• Be available for the duration of the study (12 weeks).
Minimum age
20 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Consumption of any over-the-counter medication or food (and unwilling to cease) that in the opinion of the investigator could interfere with the study (eg Policosanol, Metamucil, plant sterol margarines, psyllium).• The following items if taken need to be kept stable during the study: corticosteroids, diuretics, B-blockers, fish oil supplements, cholesterol lowering agents• History of heavy alcohol consumption (> 5 STD drinks/day)• Allergy to eggs• Type 2 diabetes controlled with insulin• Extended absences due to travel or other commitments• Person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol and restrictions.

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)
Allocation was concealed when it was done by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random allocation using computer software clinstat
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
n/a
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1687 0
Government body
Name [1] 1687 0
Australian Egg Corporation Limited
Country [1] 1687 0
Australia
Funding source category [2] 1688 0
Government body
Name [2] 1688 0
Commonwealth Scientific Research and Industrial Research Organisation
Country [2] 1688 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific Research and Industraial Organisation
Address
Country
Australia
Secondary sponsor category [1] 1489 0
None
Name [1] 1489 0
n/a
Address [1] 1489 0
Country [1] 1489 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3137 0
CSIRO Human Nutrition
Ethics committee address [1] 3137 0
Ethics committee country [1] 3137 0
Australia
Date submitted for ethics approval [1] 3137 0
Approval date [1] 3137 0
22/09/2006
Ethics approval number [1] 3137 0
05/11

Summary
Brief summary
We propose to conduct a randomised controlled trial to compare the effect of eggs to a similar amount of protein and kilojoules from meat fish and chicken in the context of a high protein energy restricted dietary pattern. Primary outcome variables are LDL cholesterol and other cardiovascular risk factors. Our hypothesis is that daily consumption of 400mg dietary cholesterol as 2 eggs compared to an equivalent protein source low in saturated fat and low in cholesterol a kilojoule restricted diet will not adversely affect these outcomes We also propose to opportunistically compare the impact of these dietary patterns on post prandial glucose metabolism, cognitive function and satiety.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27381 0
Address 27381 0
Country 27381 0
Phone 27381 0
Fax 27381 0
Email 27381 0
Contact person for public queries
Name 10636 0
Anne McGuffin
Address 10636 0
CSIRO Human Nutrition
PO Box 10041
Adelaide BC SA 5000
Country 10636 0
Australia
Phone 10636 0
+61 8 83038988
Fax 10636 0
+ 61 8 83038899
Email 10636 0
[email protected]
Contact person for scientific queries
Name 1564 0
Dr Manny Noakes
Address 1564 0
CSIRO Human Nutrition
PO Box 10041
Adelaide BC SA 5000
Country 1564 0
Australia
Phone 1564 0
+ 61 8 83038827
Fax 1564 0
+ 61 8 83038899
Email 1564 0
manny.noakes @csiro.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
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