Copenhagen Obesity Risk Assessment Study - Tabular View

Tracking Information
First Received Date ^ICMJE	April 4, 2008
Last Updated Date	April 14, 2009
Start Date ^ICMJE	April 2008
Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 14, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE (submitted: April 9, 2008)	LDL-cholesterol/LDL-cholesterol ratio [ Designated as safety issue: No ] Liver fat measured by MR-S [ Designated as safety issue: No ] Insulin sensitivity (ISI composite) from 3h OGTT [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00655902 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 14, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: April 9, 2008)	Waist circumference Visceral adipose tissue measured by MR Intramuscular fat measured by MR-S Body fat percentage measured by DEXA 24h heart rate variability measured by Holter-monitoring Cytokines in blood Cytokines in abdominal adipose tissue Ceramide in abdominal adipose tissue Metabolomics on blood and urine

Descriptive Information
Brief Title ^ICMJE	Copenhagen Obesity Risk Assessment Study
Official Title ^ICMJE	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.
Brief Summary	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.
Detailed Description
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Condition ^ICMJE	Metabolic Syndrome Abdominal Obesity Heart Disease Type 2 Diabetes
Intervention ^ICMJE	Dietary Supplement: Trans fat (soy bean oil) Dietary Supplement: Control fat (sunflower oil)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	52
Completion Date	March 2009
Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	45 Years to 70 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Denmark

Administrative Information
NCT ID ^ICMJE	NCT00655902
Responsible Party	Dr. med, prof. Arne Astrup, Department of Human Nutrition, University of Copenhagen
Study ID Numbers ^ICMJE	B237
Study Sponsor ^ICMJE	University of Copenhagen
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	University of Copenhagen
Verification Date	April 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP