Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000385246
Ethics application status
Approved
Date submitted
27/01/2009
Date registered
29/05/2009
Date last updated
29/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Gene Expression During an Energy Restricted Weight loss Diet
Scientific title
A randomized parallel study to investigate the effect of high and standard protein content on gene expression in skeletal muscle and adipose tissue in overweight/obese women.
Universal Trial Number (UTN)
Trial acronym
GE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity in women 4398 0
Condition category
Condition code
Diet and Nutrition 4454 4454 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention of fortnightly consultation with a dietitian, providing meal plans and advice aiming for the consumption of 1500 calories (6000 kJ/day)of either a high-protein or a high-carbohydrate diet for 12 weeks.
Intervention code [1] 3953 0
Lifestyle
Comparator / control treatment
Standard protein (15% of energy) energy restricted diet which is comprised of 15% calories as protein, 55% as carbohydrate and 30% as fat. Meal plans and dietary advice will be provide for 12 weeks.
Control group
Active

Outcomes
Primary outcome [1] 5515 0
Body weight measured using calibrated electronic digital scales
Timepoint [1] 5515 0
Baseline (week 0), week 2 and week 12
Primary outcome [2] 5516 0
Body Composition using a dual-energy x-ray absorptiometry (DEXA) scanner
Timepoint [2] 5516 0
Baseline (week 0) and week 12
Primary outcome [3] 5517 0
Skeletal muscle gene expression collected by tissue biopsy and analysed using deoxyribonucleic acid (DNA) microarrays
Timepoint [3] 5517 0
Baseline (week 0), week 2 and week 12
Secondary outcome [1] 9281 0
Glucose tolerance measured using an oral glucose tolerance test (consumption of a glucose load in the form of a 75g drink) and a number of blood samples collected over the following 3 hours. Plasma glucose measured by commercial assay kits
Timepoint [1] 9281 0
Baseline (-15 mins), 15, 30, 45, 60, 90, 120 and 180 minutes
Secondary outcome [2] 9282 0
Fasting blood glucose will be determined using commercial assay kits
Timepoint [2] 9282 0
Baseline (week 0), week 2, week 12
Secondary outcome [3] 9283 0
Blood plasma total cholesterol will be determined by commercial enzymatic methods
Timepoint [3] 9283 0
Baseline (week 0), week 2, week 12
Secondary outcome [4] 9284 0
Blood plasma triglycerides will be determined by commercial enzymatic methods
Timepoint [4] 9284 0
Baseline (week 0), week 2, week12
Secondary outcome [5] 9285 0
24 hour urinary urea/creatine will be analysed using commercial assay kits
Timepoint [5] 9285 0
Baseline (week 0) and week 12

Eligibility
Key inclusion criteria
Female, Aged between 40-60 years old, Body Mass Index (BMI) not greater than 40 or less than 27. Not currently participating in an exercise or weight loss program. Participants must understand the procedures involved and agree to participate in the study by giving full informed, written consent
Minimum age
40 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previously diagnosed or currently taking hypoglycaemic medication for Type 1 or 2 diabetes, Fasting blood glucose of > 7.0 mmol/L, Known allergy to anesthetics, Any abnormality of clinical significance on medical history, Currently pregnant, planning pregnancy or breastfeeding, Currently participating in a physical activity program, Currently taking a caloric restricted diet, Taking antihypertensive or cholesterol-lowering medication e.g. Lipitor, Xenical, Zetia or Hyperium. Proteinuria, a malignancy, or a history of metabolic disease such as liver, kidney, cardiovascular, respiratory or gastrointestinal disease, Cardiac (heart) abnormalit(y)ies, Cigarette smoker within 6 months prior to study commencement, Regular heavy alcohol consumption (> 5 standard drinks/day).

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 concealed when done by central randomization 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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
14/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4415 0
Self funded/Unfunded
Name [1] 4415 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO) - Human Nutrition
Country [1] 4415 0
Australia
Primary sponsor type
Government body
Name
CSIRO Human Nutrition
Address
Gate 13 Kintore Ave Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 3975 0
None
Name [1] 3975 0
Address [1] 3975 0
Country [1] 3975 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239141 0
CSIRO Human Research Ethics Committee
Ethics committee address [1] 239141 0
Ethics committee country [1] 239141 0
Australia
Date submitted for ethics approval [1] 239141 0
Approval date [1] 239141 0
22/12/2008
Ethics approval number [1] 239141 0
08/24

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29217 0
Address 29217 0
Country 29217 0
Phone 29217 0
Fax 29217 0
Email 29217 0
Contact person for public queries
Name 12464 0
Vanessa Courage
Address 12464 0
Gate 13 Kintore Ave Adelaide SA 5000
Country 12464 0
Australia
Phone 12464 0
+61 8 8303 8863
Fax 12464 0
Email 12464 0
[email protected]
Contact person for scientific queries
Name 3392 0
Dr Cassandra McIver
Address 3392 0
Gate 13 Kintore Ave Adelaide SA 5000
Country 3392 0
Australia
Phone 3392 0
+61 8 8303 8800
Fax 3392 0
+61 8 8303 8899
Email 3392 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
No additional documents have been identified.