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

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mono Unsaturated Fatty Acids in Obesity
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Dietary intervention, High-carbohydrate diet, High-fat diet, Moderate-fat diet, Obesity, Weight maintenance, Body composition, Glucose metabolism, Cardiovascular disease, Appetite regulation, Energy expenditure

Eligibility Criteria

16 Years - 35 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Outcomes

    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)

    Full Information

    First Posted
    January 10, 2006
    Last Updated
    March 24, 2010
    Sponsor
    University of Copenhagen
    Collaborators
    Aarhus University Hospital, University Hospital, Gentofte, Copenhagen, Rigshospitalet, Denmark, Technical University of Denmark, Harvard School of Public Health (HSPH), Boston Children's Hospital, Danish Meat Research Institute, Danisco, The Danish Dairy Research Foundation, Denmark, Various FOOD sponsors have provided groceries for the dietary intervention
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00274729
    Brief Title
    Mono Unsaturated Fatty Acids in Obesity - Weight Maintenance and Prevention of Lifestyle Diseases in Obese Subjects.
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2008 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Copenhagen
    Collaborators
    Aarhus University Hospital, University Hospital, Gentofte, Copenhagen, Rigshospitalet, Denmark, Technical University of Denmark, Harvard School of Public Health (HSPH), Boston Children's Hospital, Danish Meat Research Institute, Danisco, The Danish Dairy Research Foundation, Denmark, Various FOOD sponsors have provided groceries for the dietary intervention

    4. Oversight

    5. Study Description

    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., 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: Willetts new dietary recommendations. High in mono unsaturated fat and low in glycemic index (50 subjects). The traditional dietary recommendations. Low in fat and medium in glycemic index (50 subjects). 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight, Obesity
    Keywords
    Dietary intervention, High-carbohydrate diet, High-fat diet, Moderate-fat diet, Obesity, Weight maintenance, Body composition, Glucose metabolism, Cardiovascular disease, Appetite regulation, Energy expenditure

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    125 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    Mono Unsaturated Fatty Acids in Obesity
    Primary Outcome Measure Information:
    Title
    Changes in body weight
    Title
    Weight loss maintenance efficacy (>5% and >10%)
    Title
    Body composition (whole body DEXA-scanning)
    Title
    Drop-out rate
    Title
    Glucose metabolism (Oral Glucose Tolerance Test)
    Title
    Endothelium function (flow-mediated vasodilatation, FMD)
    Secondary Outcome Measure Information:
    Title
    Changes in:
    Title
    Blood lipids
    Title
    Blood glucose
    Title
    HbA1c
    Title
    Insulin
    Title
    Blood coagulation factors
    Title
    Waist
    Title
    Waist/hip-ratio
    Title
    Blood pressure
    Title
    Appetite & diet palatability
    Title
    Appetite regulating hormones (during meal test)
    Title
    Visual analogue scale (VAS) (during meal test)
    Title
    Energy expenditure (24 hour whole body indirect calorimetry)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Arne Astrup, MD DMSC
    Organizational Affiliation
    Department of Human Nutrition, The Royal Veterinary & Agricultural University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28985039
    Citation
    Hjorth MF, Due A, Larsen TM, Astrup A. Pretreatment Fasting Plasma Glucose Modifies Dietary Weight Loss Maintenance Success: Results from a Stratified RCT. Obesity (Silver Spring). 2017 Dec;25(12):2045-2048. doi: 10.1002/oby.22004. Epub 2017 Oct 6.
    Results Reference
    derived
    PubMed Identifier
    18996857
    Citation
    Due A, Larsen TM, Mu H, Hermansen K, Stender S, Astrup A. Comparison of 3 ad libitum diets for weight-loss maintenance, risk of cardiovascular disease, and diabetes: a 6-mo randomized, controlled trial. Am J Clin Nutr. 2008 Nov;88(5):1232-41. doi: 10.3945/ajcn.2007.25695.
    Results Reference
    derived
    PubMed Identifier
    18400707
    Citation
    Due A, Larsen TM, Hermansen K, Stender S, Holst JJ, Toubro S, Martinussen T, Astrup A. Comparison of the effects on insulin resistance and glucose tolerance of 6-mo high-monounsaturated-fat, low-fat, and control diets. Am J Clin Nutr. 2008 Apr;87(4):855-62. doi: 10.1093/ajcn/87.4.855.
    Results Reference
    derived

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

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