Copenhagen Obesity Risk Assessment Study

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Abdominal Obesity; Heart Disease; Type 2 Diabetes
• Interventions: Dietary Supplement: Trans fat (soy bean oil); Dietary Supplement: Control fat (sunflower oil)

• Registration Number: NCT00655902
• Lead Sponsor: University of Copenhagen

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

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-04
• Study First Submitted QC: 2008-04-09
• Study First Posted: 2008-04-10
• Primary Completion: 2009-02
• Study Completion: 2009-03
• Status Verified: 2009-04
• Last Update Submitted: 2011-04-28
• Last Update Posted: 2011-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Trans fat (soy bean oil)	-
2	Control fat (sunflower oil)	-

Primary Outcome Measures

Name	Time	Method
change in LDL-cholesterol/LDL-cholesterol ratio	week 0, 8, 16 and 28
Change in Liver fat measured by MR-S	week 0, 16 and 28
Change in Insulin sensitivity (ISI composite) from 3h OGTT	week 0, 8, 16 and 28

Secondary Outcome Measures

Name	Time	Method
Change in Visceral adipose tissue measured by MR	week 0, 16 and 28
Change in Waist circumference	week 0, 8, 16 and 28
Change in Intramuscular fat measured by MR-S (Psoas Major)	week 0, 16 and 28
Change in Body fat percentage measured by DEXA	week 0, 16 and 28
Change in 24h heart rate variability measured by Holter-monitoring	week 0, 16 and 28
Changes in Cytokines in blood	week 0, 8, 16 and 28
Changes in Cytokines in abdominal adipose tissue	week 0, 16 and 28
Changes in Ceramide in abdominal adipose tissue	week 0, 16 and 28
Changes in Metabolomic profile in blood and urine	week 0, 16 and 28

Trial Locations

Locations (1)

Department of Human Nutrition, University of Copenhagen; 🇩🇰 Frederiksberg, Copenhagen, Denmark