Copenhagen Obesity Risk Assessment Study (COBRA)

University of Copenhagen

Status: Completed

Conditions: Abdominal Obesity; Type 2 Diabetes; Heart Disease; Metabolic Syndrome

Treatments: Dietary Supplement: Trans fat (soy bean oil); Dietary Supplement: Control fat (sunflower oil)

Study type: Interventional

Funder types: Other

Identifiers

NCT00655902

B237

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: Female

Ages: 45 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Dietary Supplement: Trans fat (soy bean oil)

2

Placebo Comparator group

Treatment:

Dietary Supplement: Control fat (sunflower oil)