Copenhagen Obesity Risk Assessment Study

Type 2 Diabetes Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00655902
• Other study ID #: B237
• Status: Completed
• Phase: N/A
• First received: April 4, 2008
• Last updated: April 28, 2011
• Start date: April 2008
• Est. completion date: March 2009

Study information

• Verified date: April 2009
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Abdominal Obesity
• Diabetes Mellitus, Type 2
• Heart Disease
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Obesity, Abdominal
• Type 2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition, University of Copenhagen	Frederiksberg	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in LDL-cholesterol/LDL-cholesterol ratio		week 0, 8, 16 and 28	No
Primary	Change in Liver fat measured by MR-S		week 0, 16 and 28	No
Primary	Change in Insulin sensitivity (ISI composite) from 3h OGTT		week 0, 8, 16 and 28	No
Secondary	Change in Waist circumference		week 0, 8, 16 and 28	No
Secondary	Change in Visceral adipose tissue measured by MR		week 0, 16 and 28	No
Secondary	Change in Intramuscular fat measured by MR-S (Psoas Major)		week 0, 16 and 28	No
Secondary	Change in Body fat percentage measured by DEXA		week 0, 16 and 28	No
Secondary	Change in 24h heart rate variability measured by Holter-monitoring		week 0, 16 and 28	No
Secondary	Changes in Cytokines in blood		week 0, 8, 16 and 28	No
Secondary	Changes in Cytokines in abdominal adipose tissue		week 0, 16 and 28	No
Secondary	Changes in Ceramide in abdominal adipose tissue		week 0, 16 and 28	No
Secondary	Changes in Metabolomic profile in blood and urine		week 0, 16 and 28	No