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Completed

NCT Number: NCT00655902

Copenhagen Obesity Risk Assessment Study

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.

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Key information

Conditions

Metabolic Syndrome Abdominal Obesity Body Weight Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Disease Heart Diseases Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes

Age range

45 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Human Nutrition, University of Copenhagen

Frederiksberg, Copenhagen, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trans fat (soy bean oil)

Dietary Supplement

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.

Control fat (sunflower oil)

Dietary Supplement

Control fat from sunflower oil, with 60% oleic acid (in total 25 g/d for 16 weeks). The fat will be baked into buns.

Primary outcomes

  1. change in LDL-cholesterol/LDL-cholesterol ratio

    Time frame: week 0, 8, 16 and 28

  2. Change in Liver fat measured by MR-S

    Time frame: week 0, 16 and 28

  3. Change in Insulin sensitivity (ISI composite) from 3h OGTT

    Time frame: week 0, 8, 16 and 28

Secondary outcomes

  1. Change in Waist circumference

    Time frame: week 0, 8, 16 and 28

  2. Change in Visceral adipose tissue measured by MR

    Time frame: week 0, 16 and 28

  3. Change in Intramuscular fat measured by MR-S (Psoas Major)

    Time frame: week 0, 16 and 28

  4. Change in Body fat percentage measured by DEXA

    Time frame: week 0, 16 and 28

  5. Change in 24h heart rate variability measured by Holter-monitoring

    Time frame: week 0, 16 and 28

  6. Changes in Cytokines in blood

    Time frame: week 0, 8, 16 and 28

  7. Changes in Cytokines in abdominal adipose tissue

    Time frame: week 0, 16 and 28

  8. Changes in Ceramide in abdominal adipose tissue

    Time frame: week 0, 16 and 28

  9. Changes in Metabolomic profile in blood and urine

    Time frame: week 0, 16 and 28

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study 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.

Acronym: COBRA

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 10, 2008
Registry last updated
Apr 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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