COBRA: Copenhagen Obesity Risk Assessment Study

Sponsor

University of Copenhagen (Other)

Overall Status

Completed

CT.gov ID

NCT00655902

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome Abdominal Obesity Heart Disease Type 2 Diabetes	Dietary Supplement: Trans fat (soy bean oil) Dietary Supplement: Control fat (sunflower oil)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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.

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Feb 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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

Change in Waist circumference [week 0, 8, 16 and 28]
Change in Visceral adipose tissue measured by MR [week 0, 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]