NCT00655902

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

April 29, 2011

Status Verified

April 1, 2009

Enrollment Period

10 months

First QC Date

April 4, 2008

Last Update Submit

April 28, 2011

Conditions

Metabolic SyndromeAbdominal ObesityHeart DiseaseType 2 Diabetes

Keywords

Trans fatObesityInsulin sensitivity

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Dietary Supplement: Trans fat (soy bean oil)

2

PLACEBO COMPARATOR
Dietary Supplement: Control fat (sunflower oil)

Interventions

Trans fat (soy bean oil)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.

1
Control fat (sunflower oil)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.

2

Eligibility Criteria

Age45 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 45-70 years
  • BMI 25-32
  • Waist circumference \> 80 cm
  • Postmenopausal for at least 1 year

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Human Nutrition, University of Copenhagen

Frederiksberg, Copenhagen, 1958, Denmark

Location

Related Publications (4)

  • 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.

    PMID: 21397284RESULT

  • 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.

    PMID: 23154296RESULT

  • 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.

    PMID: 23922748DERIVED

  • 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.

    PMID: 21795740DERIVED

MeSH Terms

Conditions

Metabolic SyndromeObesity, AbdominalHeart DiseasesDiabetes Mellitus, Type 2ObesityInsulin Resistance

Interventions

Trans Fatty AcidsSoybean OilSunflower Oil

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsCardiovascular DiseasesDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, UnsaturatedFatty AcidsLipidsDietary Fats, UnsaturatedDietary FatsFatsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 4, 2008

First Posted

April 10, 2008

Study Start

April 1, 2008

Primary Completion

February 1, 2009

Study Completion

March 1, 2009

Last Updated

April 29, 2011

Record last verified: 2009-04

Locations

DK(1)