Copenhagen Obesity Risk Assessment Study - Full Text View

Sponsor:	University of Copenhagen
Information provided by:	University of Copenhagen
ClinicalTrials.gov Identifier:	NCT00655902

Purpose

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.

Condition	Intervention
Metabolic Syndrome Abdominal Obesity Heart Disease Type 2 Diabetes	Dietary Supplement: Trans fat (soy bean oil) Dietary Supplement: Control fat (sunflower oil)

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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 Heart Diseases Metabolic Syndrome Obesity

Drug Information available for: Soybean oil

U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:

change in LDL-cholesterol/LDL-cholesterol ratio [ Time Frame: week 0, 8, 16 and 28 ] [ Designated as safety issue: No ]
Change in Liver fat measured by MR-S [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]
Change in Insulin sensitivity (ISI composite) from 3h OGTT [ Time Frame: week 0, 8, 16 and 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Waist circumference [ Time Frame: week 0, 8, 16 and 28 ] [ Designated as safety issue: No ]
Change in Visceral adipose tissue measured by MR [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]
Change in Intramuscular fat measured by MR-S (Psoas Major) [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]
Change in Body fat percentage measured by DEXA [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]
Change in 24h heart rate variability measured by Holter-monitoring [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]
Changes in Cytokines in blood [ Time Frame: week 0, 8, 16 and 28 ] [ Designated as safety issue: No ]
Changes in Cytokines in abdominal adipose tissue [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]
Changes in Ceramide in abdominal adipose tissue [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]
Changes in Metabolomic profile in blood and urine [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]

Enrollment:	52
Study Start Date:	April 2008
Study Completion Date:	March 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	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.
Placebo Comparator: 2	Dietary Supplement: 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.

Eligibility

Ages Eligible for Study:	45 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655902

Locations

Denmark
Department of Human Nutrition, University of Copenhagen
Frederiksberg, Copenhagen, Denmark, 1958

Sponsors and Collaborators

University of Copenhagen

More Information

Publications:

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 Mar 10; [Epub ahead of print]

Responsible Party:	Dr. med, prof. Arne Astrup, Department of Human Nutrition, University of Copenhagen
ClinicalTrials.gov Identifier:	NCT00655902 History of Changes
Other Study ID Numbers:	B237
Study First Received:	April 4, 2008
Last Updated:	April 28, 2011
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Copenhagen:

Trans fat
Obesity
Insulin sensitivity

Additional relevant MeSH terms:

Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Obesity
Obesity, Abdominal
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases

Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism

ClinicalTrials.gov processed this record on February 12, 2012