Mono Unsaturated Fatty Acids in Obesity - Weight Maintenance and Prevention of Lifestyle Diseases in Obese Subjects.
|ClinicalTrials.gov Identifier: NCT00274729|
Recruitment Status : Completed
First Posted : January 11, 2006
Last Update Posted : March 25, 2010
|First Submitted Date ICMJE||January 10, 2006|
|First Posted Date ICMJE||January 11, 2006|
|Last Update Posted Date||March 25, 2010|
|Start Date ICMJE||January 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00274729 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Mono Unsaturated Fatty Acids in Obesity - Weight Maintenance and Prevention of Lifestyle Diseases in Obese Subjects.|
|Official Title ICMJE||MUFObes: MonoUnsaturated Fatty Acids in Obesity - a Comparison Between 3 Different Diets in Weight Maintenance and the Prevention of Lifestyle Diseases in Obese Subjects. A Randomised, Long-term Intervention Study.|
|Brief Summary||The purpose of this study is to investigate the effect of three diets different in type and amount of fat in weight maintenance and prevention of life-style diseases in obese subjects.|
The obesity epidemic has raised concerns, because of complications such as type 2 diabetes, cardiovascular disease and certain types of cancer. Much conflict and confusion about the optimal diet for weight control exists among the public.
The current dietary recommendations aim at reducing the total fat in the diet to less than 30% of calories, increasing carbohydrates to 55-60%, and protein from lean meat and dairy products to 15-20%, and to keep the intake of sugar sweetened soft-drinks limited. There is good evidence from meta-analyses of intervention studies that a low fat diet can prevent weight gain in normal weight individuals, induce a small but clinically relevant weight loss in overweight individuals, and also reduce the risk of cardiovascular disease and type 2 diabetes.
However this recommended diet may not be of the optimal composition in preventing the progressive increase in obesity and lifestyle diseases. The traditional dietary recommendation has been challenged by the epidemiologist Walter Willett, Harvard Medical School in Boston. He claims that dietary fat is less important for the development of obesity, and that the fat content of the diet can be 40-45% of the energy providing from mainly mono- and polyunsaturated fatty acids. Based on mainly large-scale observational studies ('Nurses Health Study') he has developed new dietary guidelines, expressed as a new diet pyramid. In contrast to the current guidelines, more plant oils and plant foods, limited animal products, such as meat and dairy products (even lean products), and increased intake of olive oil, nuts, etc., e.g. guidelines closer to the "Mediterranean Diet".
There is circumstantial evidence to support that this moderate fat, MUFA-rich diet will have a beneficial effect on some of the traditional risk factors for cardiovascular disease and type-2 diabetes. However, there is also growing concern that the increased total fat content will lead to weight gain and increased risk of obesity, and secondary to this, type-2 diabetes and cardiovascular disease. This debate has now been taken up by some of the finest scientific journals. To test this hypothesis the largest and longest dietary intervention trial in Denmark is carried out at the Department of Human Nutrition.
The objective is to identify the diet and diet components most effective for protection against weight gain, weight regain and prevention of life-style diseases in obese subjects. The three diets tested are according to:
The diets are ad libitum (i.e. no restriction in calorie intake), but very strict in dietary composition.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Intervention ICMJE||Behavioral: Mono Unsaturated Fatty Acids in Obesity|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||June 2008|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||16 Years to 35 Years (Child, Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Not Provided|
|Removed Location Countries|
|NCT Number ICMJE||NCT00274729|
|Other Study ID Numbers ICMJE||KF 01-172/03|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University of Copenhagen|
|PRS Account||University of Copenhagen|
|Verification Date||January 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP