Copenhagen Obesity Risk Assessment Study (COBRA)

April 28, 2011 updated by: University of Copenhagen

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen
      • Frederiksberg, Copenhagen, Denmark, 1958
        • Department of Human Nutrition, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

April 4, 2008

First Submitted That Met QC Criteria

April 9, 2008

First Posted (Estimate)

April 10, 2008

Study Record Updates

Last Update Posted (Estimate)

April 29, 2011

Last Update Submitted That Met QC Criteria

April 28, 2011

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B237

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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