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Copenhagen Obesity Risk Assessment Study

NCT ID: NCT00655902

Last Updated: 2011-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metabolic Syndrome Abdominal Obesity Heart Disease Type 2 Diabetes

Keywords

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Trans fat Obesity Insulin sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Trans fat (soy bean oil)

Intervention Type DIETARY_SUPPLEMENT

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

Group Type PLACEBO_COMPARATOR

Control fat (sunflower oil)

Intervention Type DIETARY_SUPPLEMENT

Control fat from sunflower oil, with 60% oleic acid (in total 25 g/d for 16 weeks). The fat will be baked into buns.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Department of Human Nutrition, University of Copenhagen

Locations

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Department of Human Nutrition, University of Copenhagen

Frederiksberg, Copenhagen, Denmark

Site Status

Countries

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Denmark

References

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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 Jul;60(7):906-13. doi: 10.1016/j.metabol.2011.01.009. Epub 2011 Mar 11.

Reference Type RESULT
PMID: 21397284 (View on PubMed)

Bendsen NT, Chabanova E, Thomsen HS, Larsen TM, Newman JW, Stender S, Dyerberg J, Haugaard SB, Astrup A. Effect of trans fatty acid intake on abdominal and liver fat deposition and blood lipids: a randomized trial in overweight postmenopausal women. Nutr Diabetes. 2011 Jan 31;1(1):e4. doi: 10.1038/nutd.2010.4.

Reference Type RESULT
PMID: 23154296 (View on PubMed)

Gurdeniz G, Rago D, Bendsen NT, Savorani F, Astrup A, Dragsted LO. Effect of trans fatty acid intake on LC-MS and NMR plasma profiles. PLoS One. 2013 Jul 29;8(7):e69589. doi: 10.1371/journal.pone.0069589. Print 2013.

Reference Type DERIVED
PMID: 23922748 (View on PubMed)

Bendsen NT, Stender S, Szecsi PB, Pedersen SB, Basu S, Hellgren LI, Newman JW, Larsen TM, Haugaard SB, Astrup A. Effect of industrially produced trans fat on markers of systemic inflammation: evidence from a randomized trial in women. J Lipid Res. 2011 Oct;52(10):1821-8. doi: 10.1194/jlr.M014738. Epub 2011 Jul 27.

Reference Type DERIVED
PMID: 21795740 (View on PubMed)

Other Identifiers

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B237

Identifier Type: -

Identifier Source: org_study_id