Copenhagen Obesity Risk Assessment Study (COBRA)

This study has been completed.
Sponsor:
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00655902
First received: April 4, 2008
Last updated: April 28, 2011
Last verified: April 2009
  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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

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

Secondary Outcome Measures:
  • Change in Waist circumference [ Time Frame: week 0, 8, 16 and 28 ] [ Designated as safety issue: No ]
  • Change in Visceral adipose tissue measured by MR [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]
  • Change in Intramuscular fat measured by MR-S (Psoas Major) [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]
  • Change in Body fat percentage measured by DEXA [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]
  • Change in 24h heart rate variability measured by Holter-monitoring [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]
  • Changes in Cytokines in blood [ Time Frame: week 0, 8, 16 and 28 ] [ Designated as safety issue: No ]
  • Changes in Cytokines in abdominal adipose tissue [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]
  • Changes in Ceramide in abdominal adipose tissue [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]
  • Changes in Metabolomic profile in 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
Experimental: 1 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.
Placebo Comparator: 2 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
Department of Human Nutrition, University of Copenhagen
Frederiksberg, Copenhagen, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. med, prof. Arne Astrup, Department of Human Nutrition, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00655902     History of Changes
Other Study ID Numbers: B237
Study First Received: April 4, 2008
Last Updated: April 28, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Obesity
Obesity, Abdominal
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism

ClinicalTrials.gov processed this record on April 17, 2014