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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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

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

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.

Key inclusion criteria
Have at least one CVD risk factor other than obesityBMI 27-40kg/m2
Minimum age
20 Years
Maximum age
65 Years
Both males and females
Can healthy volunteers participate?
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
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Other design features
Two dietary patterns
Phase 3 / Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment status
Active, not recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
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
Country [1] 1135 0
Primary sponsor type
Commercial sector/Industry
Meat and Livestock Australia
Secondary sponsor category [1] 992 0
Government body
Name [1] 992 0
CSIRO Human Nutrition
Address [1] 992 0
Country [1] 992 0

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

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

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
Phone 9653 0
+61 8 83038827
Fax 9653 0
+61 8 83038899
Email 9653 0
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
Phone 581 0
+61 8 83038827
Fax 581 0
+61 8 83038899
Email 581 0

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
Dimensions AIComparison of the effects of 52 weeks weight loss with either a high-protein or high-carbohydrate diet on body composition and cardiometabolic risk factors in overweight and obese males2012
EmbasePsychological well-being response to high protein and high carbohydrate weight loss diets in overweight and obese men: Arandomised trial.2013
EmbaseLong-term effects of a randomised controlled trial comparing high protein or high carbohydrate weight loss diets on testosterone, SHBG, erectile and urinary function in overweight and obese men.2016
N.B. These documents automatically identified may not have been verified by the study sponsor.