Metabolic SyndromeCOBRANCT00655902
Copenhagen Obesity Risk Assessment Study
A study testing Trans fat (soy bean oil) in people with Metabolic Syndrome and Abdominal Obesity, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Abdominal Obesity, Heart Disease
- What is being tested?
- Trans fat (soy bean oil)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 45-70 years
- BMI 25-32
- Waist circumference > 80 cm
- Postmenopausal for at least 1 year
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Department of Human Nutrition, University of Copenhagen
Frederiksberg, Copenhagen, 1958
About this 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.
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.
- Conditions
- Metabolic Syndrome, Abdominal Obesity, Heart Disease, Type 2 Diabetes
- Being tested
- Trans fat (soy bean oil), Control fat (sunflower oil)
- Keywords
- Trans fat, Obesity, Insulin sensitivity
- Medical subject headings
- Metabolic Syndrome, Obesity, Abdominal, Heart Diseases, Diabetes Mellitus, Type 2, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Dietary Supplement: Trans fat (soy bean oil) |
| 2 | Placebo comparator | Not described Receives: Dietary Supplement: Control fat (sunflower oil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in LDL-cholesterol/LDL-cholesterol ratio
Measured: week 0, 8, 16 and 28
Change in Liver fat measured by MR-S
Measured: week 0, 16 and 28
Change in Insulin sensitivity (ISI composite) from 3h OGTT
Measured: week 0, 8, 16 and 28
Secondary outcomes (9)
Change in Waist circumference
Measured: week 0, 8, 16 and 28
Change in Visceral adipose tissue measured by MR
Measured: week 0, 16 and 28
Change in Intramuscular fat measured by MR-S (Psoas Major)
Measured: week 0, 16 and 28
Change in Body fat percentage measured by DEXA
Measured: week 0, 16 and 28
Change in 24h heart rate variability measured by Holter-monitoring
Measured: week 0, 16 and 28
Changes in Cytokines in blood
Measured: week 0, 8, 16 and 28
Changes in Cytokines in abdominal adipose tissue
Measured: week 0, 16 and 28
Changes in Ceramide in abdominal adipose tissue
Measured: week 0, 16 and 28
Changes in Metabolomic profile in blood and urine
Measured: week 0, 16 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionFeb 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655902
- Sponsor's protocol ID
- B237
- Acronym
- COBRA
- Status last verified
- Apr 2009
- First submitted
- 4 Apr 2008
- Last updated
- 29 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
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 Jul;60(7):906-13. doi: 10.1016/j.metabol.2011.01.009. Epub 2011 Mar 11.
PubMed 21397284Bendsen 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.
PubMed 23154296Gurdeniz 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.
PubMed 23922748Bendsen 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.
PubMed 21795740
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00655902
- Acronym / sponsor ID
- COBRA / B237
- Conditions
- Metabolic Syndrome, Abdominal Obesity, Heart Disease, Type 2 Diabetes
- Keywords
- Trans fat, Obesity, Insulin sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 10 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Trans fat (soy bean oil) |
| 2 | Placebo comparator | Dietary Supplement: Control fat (sunflower oil) |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 45-70 years
- BMI 25-32
- Waist circumference > 80 cm
- Postmenopausal for at least 1 year
Key exclusion criteria (12 listed)
- BP > 160/100 mmHg
- Fasted blood glucose > 7 mM
- Fasted LDL-cholesterol > 6 mM
- Fasted triglycerides > 3 mM
- Diabetes mellitus or other chronic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | 1 |
| 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. | Dietary supplement | 2 |
Primary outcome
change in LDL-cholesterol/LDL-cholesterol ratio
Time frame: week 0, 8, 16 and 28
Change in Liver fat measured by MR-S
Time frame: week 0, 16 and 28
Change in Insulin sensitivity (ISI composite) from 3h OGTT
Time frame: week 0, 8, 16 and 28
9 secondary outcomes
Change in Waist circumference
Time frame: week 0, 8, 16 and 28
Change in Visceral adipose tissue measured by MR
Time frame: week 0, 16 and 28
Change in Intramuscular fat measured by MR-S (Psoas Major)
Time frame: week 0, 16 and 28
Change in Body fat percentage measured by DEXA
Time frame: week 0, 16 and 28
Change in 24h heart rate variability measured by Holter-monitoring
Time frame: week 0, 16 and 28
Changes in Cytokines in blood
Time frame: week 0, 8, 16 and 28
Changes in Cytokines in abdominal adipose tissue
Time frame: week 0, 16 and 28
Changes in Ceramide in abdominal adipose tissue
Time frame: week 0, 16 and 28
Changes in Metabolomic profile in blood and urine
Time frame: week 0, 16 and 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2011.
- Results publication: PubMed 21397284Bendsen 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.
- Results publication: PubMed 23154296Bendsen 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.
- Derived from this study: PubMed 23922748Gurdeniz 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.
- Derived from this study: PubMed 21795740Bendsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans fat (soy bean oil) in people with Metabolic Syndrome and Abdominal Obesity, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in LDL-cholesterol/LDL-cholesterol ratio (time frame: week 0, 8, 16 and 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00655902, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2011; AzTrials last refreshed its copy on 29 Oct 2026.