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Trial registered on ANZCTR


Registration number
ACTRN12606000002583
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
3/01/2006
Date last updated
3/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Diet and weight loss in men
Scientific title
The effect of a high protein low carbohydrate compared to a high carbohydrate diet moderate protein diet on weight loss and wellbeing in obese men
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 963 0
Condition category
Condition code
Diet and Nutrition 1035 1035 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants assigned to a high protein (35% of energy) for 12 months.
Intervention code [1] 464 0
Lifestyle
Comparator / control treatment
Participants assigned to high carbohydrate diet (58% of energy) for 12 months.
Control group
Active

Outcomes
Primary outcome [1] 1385 0
Weight loss
Timepoint [1] 1385 0
At 12 and 52 weeks after start of diet intervention
Secondary outcome [1] 2449 0
FMD, lipids, insulin glucose CRP, blood pressure folate, homocysteine body composition.
Timepoint [1] 2449 0
At 12 and 52 weeks after start of diet intervention.

Eligibility
Key inclusion criteria
Have at least one CVD risk factor other than obesityBMI 27-40kg/m2
Minimum age
20 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Use of any form of drug therapy or medication or supplements on a regular basis that may interfere with bowel function (e.g. laxatives, antibiotics, anti-diarrhoeals or probiotics)Consumption of any over-the-counter medication that in the opinion of the investigator could interfere with the study.History or presence of gastrointestinal, renal or hepatic disease of any cause.

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)
No
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
Two dietary patterns
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 1135 0
Commercial sector/Industry
Name [1] 1135 0
Meat and Livestock Australia
Address [1] 1135 0
Country [1] 1135 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Meat and Livestock Australia
Address
Country
Australia
Secondary sponsor category [1] 992 0
Government body
Name [1] 992 0
CSIRO Human Nutrition
Address [1] 992 0
Country [1] 992 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2447 0
Adelaide
Ethics committee address [1] 2447 0
Ethics committee country [1] 2447 0
Australia
Date submitted for ethics approval [1] 2447 0
Approval date [1] 2447 0
Ethics approval number [1] 2447 0

Summary
Brief summary
The replacement of dietary carbohydrate with protein, combined with a low intake of fat, has been shown to induce larger weight loss in overweight participants when compared with conventional high carbohydrate/low fat diets and is an increasingly popular method for weight loss among the general public, suggesting this is a favourable weight loss regime for overweight people. There are concerns over the safety of the use of high protein-red meat diets, as red meat, although controversial, is proposed to increase the risk of colon cancer. Although a high protein-red meat diet may be associated with increasing the risk of colon cancer due to the higher content of meat, such a diet is also associated with weight loss and improved insulin sensitivity, which reduce colon cancer risk. From this it can be suggested that a higher protein dietary pattern used for weight loss that remains low in fat and high in fibre rich foods, in association with moderate exercise may not increase the risk of colon cancer. The impact of long term use of high protein-red meat diets on colon cancer risk has not been assessed. This study will assess the safety of high protein-red meat diets as a method for weight loss in overweight participants. It will also investigate a series of secondary outcomes that impact on total health status.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36095 0
Address 36095 0
Country 36095 0
Phone 36095 0
Fax 36095 0
Email 36095 0
Contact person for public queries
Name 9653 0
Dr Manny Noakes
Address 9653 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO) Human Nutrition
PO Box 10041 BC
Adelaide SA 5000
Country 9653 0
Australia
Phone 9653 0
+61 8 83038827
Fax 9653 0
+61 8 83038899
Email 9653 0
manny.noakes@csiro.au
Contact person for scientific queries
Name 581 0
Dr Manny Noakes
Address 581 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO) Human Nutrition
PO Box 10041 BC
Adelaide SA 5000
Country 581 0
Australia
Phone 581 0
+61 8 83038827
Fax 581 0
+61 8 83038899
Email 581 0
manny.noakes@csiro.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary