Copenhagen Obesity Risk Assessment Study - Full Text View

Sponsored by:	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:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy 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.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Dietary Supplements Diets Heart Disease in Women Heart Diseases Obesity

Drug Information available for: Soybean oil

U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Waist circumference [ Time Frame: week 0, 8, 16 and 28 ] [ Designated as safety issue: No ]
Visceral adipose tissue measured by MR [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]
Intramuscular fat measured by MR-S (Psoas Major) [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]
Body fat percentage measured by DEXA [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]
24h heart rate variability measured by Holter-monitoring [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]
Cytokines in blood [ Time Frame: week 0, 8, 16 and 28 ] [ Designated as safety issue: No ]
Cytokines in abdominal adipose tissue [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]
Ceramide in abdominal adipose tissue [ Time Frame: week 0, 16 and 28 ] [ Designated as safety issue: No ]
Metabolomics on 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
1: Experimental	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.
2: Placebo Comparator	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, Copenhagen
Department of Human Nutrition, University of Copenhagen
Frederiksberg, Copenhagen, Denmark, 1958

Sponsors and Collaborators

University of Copenhagen

More Information

No publications provided

Responsible Party:	Department of Human Nutrition, University of Copenhagen ( Dr. med, prof. Arne Astrup )
Study ID Numbers:	B237
Study First Received:	April 4, 2008
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00655902 History of Changes
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Copenhagen:

Trans fat
Obesity
Insulin sensitivity

Study placed in the following topic categories:

Obesity
Heart Diseases
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Overweight
Insulin
Body Weight
Signs and Symptoms

Diabetes Mellitus, Type 2
Nutrition Disorders
Overnutrition
Endocrinopathy
Glucose Metabolism Disorders
Sunflower
Metabolic Disorder
Soy Bean

Additional relevant MeSH terms:

Obesity
Disease
Heart Diseases
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Overweight
Body Weight

Signs and Symptoms
Pathologic Processes
Syndrome
Diabetes Mellitus, Type 2
Nutrition Disorders
Cardiovascular Diseases
Overnutrition
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on July 06, 2009