Abdominal Obesity, Heart Disease, Metabolic Syndrome, Type 2 Diabetes
Conditions
Keywords
Trans fat, Obesity, Insulin sensitivity
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.
Interventions
DIETARY_SUPPLEMENTTrans 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.
DIETARY_SUPPLEMENTControl 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.
Sponsors
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Denmark
Outcome results
None listed