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

March 24, 2010 updated by: University of Copenhagen

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

125

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Aarhus University Hospital
Rigshospitalet, Denmark
Boston Children's Hospital
The Danish Dairy Research Foundation, Denmark
Harvard School of Public Health (HSPH)
University Hospital, Gentofte, Copenhagen
Danisco
Technical University of Denmark
Danish Meat Research Institute
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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion

June 1, 2008

Study Registration Dates

First Submitted

January 10, 2006

First Submitted That Met QC Criteria

January 10, 2006

First Posted (Estimate)

January 11, 2006

Study Record Updates

Last Update Posted (Estimate)

March 25, 2010

Last Update Submitted That Met QC Criteria

March 24, 2010

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KF 01-172/03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe