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Copenhagen Obesity Risk Assessment Study (COBRA)

Primary Purpose

Metabolic Syndrome, Abdominal Obesity, Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Trans fat (soy bean oil)
Control fat (sunflower oil)
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring Trans fat, Obesity, Insulin sensitivity

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Human Nutrition, University of Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

change in LDL-cholesterol/LDL-cholesterol ratio
Change in Liver fat measured by MR-S
Change in Insulin sensitivity (ISI composite) from 3h OGTT

Secondary Outcome Measures

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

Full Information

First Posted
April 4, 2008
Last Updated
April 28, 2011
Sponsor
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT00655902
Brief Title
Copenhagen Obesity Risk Assessment Study
Acronym
COBRA
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 Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Copenhagen

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Abdominal Obesity, Heart Disease, Type 2 Diabetes
Keywords
Trans fat, Obesity, Insulin sensitivity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Trans fat (soy bean oil)
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Control fat (sunflower oil)
Intervention Description
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 Outcome Measure Information:
Title
change in LDL-cholesterol/LDL-cholesterol ratio
Time Frame
week 0, 8, 16 and 28
Title
Change in Liver fat measured by MR-S
Time Frame
week 0, 16 and 28
Title
Change in Insulin sensitivity (ISI composite) from 3h OGTT
Time Frame
week 0, 8, 16 and 28
Secondary Outcome Measure Information:
Title
Change in Waist circumference
Time Frame
week 0, 8, 16 and 28
Title
Change in Visceral adipose tissue measured by MR
Time Frame
week 0, 16 and 28
Title
Change in Intramuscular fat measured by MR-S (Psoas Major)
Time Frame
week 0, 16 and 28
Title
Change in Body fat percentage measured by DEXA
Time Frame
week 0, 16 and 28
Title
Change in 24h heart rate variability measured by Holter-monitoring
Time Frame
week 0, 16 and 28
Title
Changes in Cytokines in blood
Time Frame
week 0, 8, 16 and 28
Title
Changes in Cytokines in abdominal adipose tissue
Time Frame
week 0, 16 and 28
Title
Changes in Ceramide in abdominal adipose tissue
Time Frame
week 0, 16 and 28
Title
Changes in Metabolomic profile in blood and urine
Time Frame
week 0, 16 and 28

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Human Nutrition, University of Copenhagen
City
Frederiksberg
State/Province
Copenhagen
ZIP/Postal Code
1958
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
21397284
Citation
Bendsen NT, Haugaard SB, Larsen TM, Chabanova E, Stender S, Astrup A. Effect of trans-fatty acid intake on insulin sensitivity and intramuscular lipids--a randomized trial in overweight postmenopausal women. Metabolism. 2011 Jul;60(7):906-13. doi: 10.1016/j.metabol.2011.01.009. Epub 2011 Mar 11.
Results Reference
result
PubMed Identifier
23154296
Citation
Bendsen NT, Chabanova E, Thomsen HS, Larsen TM, Newman JW, Stender S, Dyerberg J, Haugaard SB, Astrup A. Effect of trans fatty acid intake on abdominal and liver fat deposition and blood lipids: a randomized trial in overweight postmenopausal women. Nutr Diabetes. 2011 Jan 31;1(1):e4. doi: 10.1038/nutd.2010.4.
Results Reference
result
PubMed Identifier
23922748
Citation
Gurdeniz G, Rago D, Bendsen NT, Savorani F, Astrup A, Dragsted LO. Effect of trans fatty acid intake on LC-MS and NMR plasma profiles. PLoS One. 2013 Jul 29;8(7):e69589. doi: 10.1371/journal.pone.0069589. Print 2013.
Results Reference
derived
PubMed Identifier
21795740
Citation
Bendsen NT, Stender S, Szecsi PB, Pedersen SB, Basu S, Hellgren LI, Newman JW, Larsen TM, Haugaard SB, Astrup A. Effect of industrially produced trans fat on markers of systemic inflammation: evidence from a randomized trial in women. J Lipid Res. 2011 Oct;52(10):1821-8. doi: 10.1194/jlr.M014738. Epub 2011 Jul 27.
Results Reference
derived

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Copenhagen Obesity Risk Assessment Study

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