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Copenhagen Obesity Risk Assessment Study (COBRA)
This study has been completed.
First Received: April 4, 2008   Last Updated: April 14, 2009   History of Changes
Sponsored by: University of Copenhagen
Information provided by: University of Copenhagen
ClinicalTrials.gov Identifier: NCT00655902
  Purpose

The aim of the present study is to assess the effect of a high intake of industrially produced trans fatty acids for 16 weeks on abdominal obesity and risk markers of type 2 diabetes and heart disease in healthy, moderately overweight, postmenopausal women.


Condition Intervention
Metabolic Syndrome
Abdominal Obesity
Heart Disease
Type 2 Diabetes
 Dietary Supplement: Trans fat (soy bean oil)
Dietary Supplement: Control fat (sunflower oil)

MedlinePlus related topics: Diabetes Dietary Supplements Diets Heart Disease in Women Heart Diseases Obesity
Drug Information available for: Soybean oil
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title: Copenhagen Obesity Risk Assessment Study - A Double Blind Randomized Dietary Intervention Study Examining the Effect of a High Intake of Trans Fatty Acids on Abdominal Obesity and Risk Markers of Type 2 Diabetes and Cardiovascular Disease.

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • LDL-cholesterol/LDL-cholesterol ratio [ Time Frame: week 0, 8, 16 and 28 ] [ Designated as safety issue: No ]
  • Liver fat measured by MR-S [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]
  • Insulin sensitivity (ISI composite) from 3h OGTT [ Time Frame: week 0, 8, 16 and 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Waist circumference [ Time Frame: week 0, 8, 16 and 28 ] [ Designated as safety issue: No ]
  • Visceral adipose tissue measured by MR [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]
  • Intramuscular fat measured by MR-S (Psoas Major) [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]
  • Body fat percentage measured by DEXA [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]
  • 24h heart rate variability measured by Holter-monitoring [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]
  • Cytokines in blood [ Time Frame: week 0, 8, 16 and 28 ] [ Designated as safety issue: No ]
  • Cytokines in abdominal adipose tissue [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]
  • Ceramide in abdominal adipose tissue [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]
  • Metabolomics on blood and urine [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: April 2008
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Dietary Supplement: Trans fat (soy bean oil)
Industrially produced trans fatty acid from soy bean oil (15 g/d for 16 weeks). The fat (a total of 25 g/d) will be baked into buns.
2: Placebo Comparator Dietary Supplement: Control fat (sunflower oil)
Control fat from sunflower oil, with 60% oleic acid (in total 25 g/d for 16 weeks). The fat will be baked into buns.

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 45-70 years
  • BMI 25-32
  • Waist circumference > 80 cm
  • Postmenopausal for at least 1 year

Exclusion Criteria:

  • BP > 160/100 mmHg
  • Fasted blood glucose > 7 mM
  • Fasted LDL-cholesterol > 6 mM
  • Fasted triglycerides > 3 mM
  • Diabetes mellitus or other chronic diseases
  • Current or previous cardiovascular disease
  • Weight change > 3 kg within last 2 months
  • Use of anti-hypertensive drugs
  • Use of statins/fibrates
  • Use of fish oil supplements
  • Smoking
  • Hard physical activity > 10 h/week
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00655902

Locations
Denmark, Copenhagen
Department of Human Nutrition, University of Copenhagen
Frederiksberg, Copenhagen, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
  More Information

No publications provided

Responsible Party: Department of Human Nutrition, University of Copenhagen ( Dr. med, prof. Arne Astrup )
Study ID Numbers: B237
Study First Received: April 4, 2008
Last Updated: April 14, 2009
ClinicalTrials.gov Identifier: NCT00655902     History of Changes
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Copenhagen:
Trans fat
Obesity
Insulin sensitivity

Study placed in the following topic categories:
Obesity
Heart Diseases
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Overweight
Insulin
Body Weight
 Signs and Symptoms
Diabetes Mellitus, Type 2
Nutrition Disorders
Overnutrition
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:
Obesity
Disease
Heart Diseases
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Overweight
Body Weight
 Signs and Symptoms
Pathologic Processes
Syndrome
Diabetes Mellitus, Type 2
Nutrition Disorders
Cardiovascular Diseases
Overnutrition
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009



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