Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
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
Query!
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
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Obesity
963
0
Query!
Condition category
Condition code
Diet and Nutrition
1035
1035
0
0
Query!
Obesity
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Participants assigned to a high protein (35% of energy) for 12 months.
Query!
Intervention code [1]
464
0
Lifestyle
Query!
Comparator / control treatment
Participants assigned to high carbohydrate diet (58% of energy) for 12 months.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
1385
0
Weight loss
Query!
Assessment method [1]
1385
0
Query!
Timepoint [1]
1385
0
At 12 and 52 weeks after start of diet intervention
Query!
Secondary outcome [1]
2449
0
FMD, lipids, insulin glucose CRP, blood pressure folate, homocysteine body composition.
Query!
Assessment method [1]
2449
0
Query!
Timepoint [1]
2449
0
At 12 and 52 weeks after start of diet intervention.
Query!
Eligibility
Key inclusion criteria
Have at least one CVD risk factor other than obesityBMI 27-40kg/m2
Query!
Minimum age
20
Years
Query!
Query!
Maximum age
65
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation using computer software Clinstat
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Two dietary patterns
Query!
Phase
Phase 3 / Phase 4
Query!
Type of endpoint/s
Safety/efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Date of first participant enrolment
Anticipated
1/03/2005
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
120
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Funding & Sponsors
Funding source category [1]
1135
0
Commercial sector/Industry
Query!
Name [1]
1135
0
Meat and Livestock Australia
Query!
Address [1]
1135
0
Query!
Country [1]
1135
0
Australia
Query!
Primary sponsor type
Commercial sector/Industry
Query!
Name
Meat and Livestock Australia
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
992
0
Government body
Query!
Name [1]
992
0
CSIRO Human Nutrition
Query!
Address [1]
992
0
Query!
Country [1]
992
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
2447
0
Adelaide
Query!
Ethics committee address [1]
2447
0
Query!
Ethics committee country [1]
2447
0
Australia
Query!
Date submitted for ethics approval [1]
2447
0
Query!
Approval date [1]
2447
0
Query!
Ethics approval number [1]
2447
0
Query!
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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
36095
0
Query!
Address
36095
0
Query!
Country
36095
0
Query!
Phone
36095
0
Query!
Fax
36095
0
Query!
Email
36095
0
Query!
Contact person for public queries
Name
9653
0
Dr Manny Noakes
Query!
Address
9653
0
Commonwealth Scientific and Industrial Research Organisation (CSIRO) Human Nutrition
PO Box 10041 BC
Adelaide SA 5000
Query!
Country
9653
0
Australia
Query!
Phone
9653
0
+61 8 83038827
Query!
Fax
9653
0
+61 8 83038899
Query!
Email
9653
0
[email protected]
Query!
Contact person for scientific queries
Name
581
0
Dr Manny Noakes
Query!
Address
581
0
Commonwealth Scientific and Industrial Research Organisation (CSIRO) Human Nutrition
PO Box 10041 BC
Adelaide SA 5000
Query!
Country
581
0
Australia
Query!
Phone
581
0
+61 8 83038827
Query!
Fax
581
0
+61 8 83038899
Query!
Email
581
0
[email protected]
Query!
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
Source
Title
Year of Publication
DOI
Embase
Long-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
https://dx.doi.org/10.1371/journal.pone.0161297
Embase
Psychological well-being response to high protein and high carbohydrate weight loss diets in overweight and obese men: Arandomised trial.
2013
https://dx.doi.org/10.1016/j.clnme.2013.08.002
Dimensions AI
Comparison 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 males
2012
https://doi.org/10.1038/nutd.2012.11
N.B. These documents automatically identified may not have been verified by the study sponsor.
Download to PDF