Viewing Study NCT00274729



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Last Modification Date: 2024-10-26 @ 9:22 AM
Study NCT ID: NCT00274729
Status: COMPLETED
Last Update Posted: 2010-03-25
First Post: 2006-01-10

Brief Title: Mono Unsaturated Fatty Acids in Obesity - Weight Maintenance and Prevention of Lifestyle Diseases in Obese Subjects
Sponsor: University of Copenhagen
Organization: University of Copenhagen

Study Overview

Official Title: 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
Status: COMPLETED
Status Verified Date: 2006-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
Detailed Description: 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 eg 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

1 Willetts new dietary recommendations High in mono unsaturated fat and low in glycemic index 50 subjects
2 The traditional dietary recommendations Low in fat and medium in glycemic index 50 subjects
3 The average Danish diet Control High in fat and high in glycemic index 25 subjects

The diets are ad libitum ie no restriction in calorie intake but very strict in dietary composition

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None