Mono Unsaturated Fatty Acids in Obesity - Weight Maintenance and Prevention of Lifestyle Diseases in Obese Subjects.

This study has been completed.
Sponsor:
Collaborators:
Department of Endocrinology and Metabolism, Århus Amtssygehus, Denmark
University Hospital, Gentofte, Copenhagen
Rigshospitalet, Denmark
Technical University of Denmark
Harvard School of Public Health
Children's Hospital Boston
Danske Slagterier (Danish Meat Research Institute)
Danisco
The Danish Dairy Research Foundation, Denmark
Various FOOD sponsors have provided groceries for the dietary intervention
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00274729
First received: January 10, 2006
Last updated: March 24, 2010
Last verified: January 2006
  Purpose

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.


Condition Intervention
Overweight
Obesity
Behavioral: Mono Unsaturated Fatty Acids in Obesity

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Changes in body weight
  • Weight loss maintenance efficacy (>5% and >10%)
  • Body composition (whole body DEXA-scanning)
  • Drop-out rate
  • Glucose metabolism (Oral Glucose Tolerance Test)
  • Endothelium function (flow-mediated vasodilatation, FMD)

Secondary Outcome Measures:
  • Changes in:
  • Blood lipids
  • Blood glucose
  • HbA1c
  • Insulin
  • Blood coagulation factors
  • Waist
  • Waist/hip-ratio
  • Blood pressure
  • Appetite & diet palatability
  • Appetite regulating hormones (during meal test)
  • Visual analogue scale (VAS) (during meal test)
  • Energy expenditure (24 hour whole body indirect calorimetry)

Estimated Enrollment: 125
Study Start Date: January 2004
Estimated Study Completion Date: June 2008
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., 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:

  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 (i.e. no restriction in calorie intake), but very strict in dietary composition.

  Eligibility

Ages Eligible for Study:   16 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age: 16-35 years
  • Body mass index (kg/m2): 28-36

Exclusion Criteria:

  • Body weight fluctuations > 3 kg over the previous 2 months
  • Smoking

Presence of:

  • Cardiovascular diseases, cancer tumours, kidney or lever diseases, infections or endocrinological diseases, malabsorption disorders
  • Systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg
  • Hypercholesterolemia with changes in pharmacological treatment within the last 2 months
  • Regular use of medicine other than birth pills, any psychological disorders, known or presumed abuse of alcohol, allergies to any food, special diets (eg. vegetarian) or particular dislikes
  • Pregnancy, lactating or planning pregnancy within 18 month from enrolment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274729

Sponsors and Collaborators
University of Copenhagen
Department of Endocrinology and Metabolism, Århus Amtssygehus, Denmark
University Hospital, Gentofte, Copenhagen
Rigshospitalet, Denmark
Technical University of Denmark
Harvard School of Public Health
Children's Hospital Boston
Danske Slagterier (Danish Meat Research Institute)
Danisco
The Danish Dairy Research Foundation, Denmark
Various FOOD sponsors have provided groceries for the dietary intervention
Investigators
Principal Investigator: Arne Astrup, MD DMSC Department of Human Nutrition, The Royal Veterinary & Agricultural University
  More Information

No publications provided by University of Copenhagen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00274729     History of Changes
Other Study ID Numbers: KF 01-172/03
Study First Received: January 10, 2006
Last Updated: March 24, 2010
Health Authority: Denmark: The Ministry of the Interior and Health

Keywords provided by University of Copenhagen:
Dietary intervention
High-carbohydrate diet
High-fat diet
Moderate-fat diet
Obesity
Weight maintenance
Body composition
Glucose metabolism
Cardiovascular disease
Appetite regulation
Energy expenditure

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014