Clinical trial NCT00655902: Copenhagen Obesity Risk Assessment Study
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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Abdominal Obesity
Heart Disease
Type 2 Diabetes
Keywords: Trans fat
Obesity
Insulin sensitivity
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2008-04-10
Enrollment: 52
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: change in LDL-cholesterol/LDL-cholesterol ratio
timeFrame: week 0, 8, 16 and 28
measure: Change in Liver fat measured by MR-S
timeFrame: week 0, 16 and 28
measure: Change in Insulin sensitivity (ISI composite) from 3h OGTT
timeFrame: week 0, 8, 16 and 28
Secondary outcomes:
measure: Change in Waist circumference
timeFrame: week 0, 8, 16 and 28
measure: Change in Visceral adipose tissue measured by MR
timeFrame: week 0, 16 and 28
measure: Change in Intramuscular fat measured by MR-S (Psoas Major)
timeFrame: week 0, 16 and 28
measure: Change in Body fat percentage measured by DEXA
timeFrame: week 0, 16 and 28
measure: Change in 24h heart rate variability measured by Holter-monitoring
timeFrame: week 0, 16 and 28
measure: Changes in Cytokines in blood
timeFrame: week 0, 8, 16 and 28
measure: Changes in Cytokines in abdominal adipose tissue
timeFrame: week 0, 16 and 28
measure: Changes in Ceramide in abdominal adipose tissue
timeFrame: week 0, 16 and 28
measure: Changes in Metabolomic profile in blood and urine
timeFrame: week 0, 16 and 28
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Human Nutrition, University of Copenhagen
state: Copenhagen
Study officials:
References:
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.
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.
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.
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.