Copenhagen Obesity Risk Assessment Study

Study Overview
=================
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.

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.

Conditions
-----------------
Metabolic Syndrome, Abdominal Obesity, Heart Disease, Type 2 Diabetes

Intervention / Treatment
-----------------
* Dietary Supplement: Trans fat (soy bean oil)
* Dietary Supplement: Control fat (sunflower oil)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Dietary Supplement: Trans fat (soy bean oil)<br>* 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.<br>|
| Placebo Comparator: 2<br> | Dietary Supplement: Control fat (sunflower oil)<br>* Control fat from sunflower oil, with 60% oleic acid (in total 25 g/d for 16 weeks). The fat will be baked into buns.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trans fat, Obesity, Insulin sensitivity