Metabolic SyndromeNCT00429195
The Effect of Dietary Fat Modification on Risk Factors Associated With the Metabolic Syndrome
A study testing Dietary Fatty Acid Modification in people with Metabolic Syndrome, run by University College Dublin at 1 site in Ireland.
Trial summary
The LIPGENE Human Dietary Intervention Study, multi-centre, trans -European, single-blinded, randomised, controlled trial with two principal aims. Firstly to determine the relative efficacy of reducing dietary SFA consumption, by altering quality of dietary fat and reducing the quantity of dietary fat, on metabolic… Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Dietary Fatty Acid Modification
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 480 participants
- Where
- 1 siteIreland
- Study dates
- Feb 2004to Jan 2007
- 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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gender: males and females (not pregnant or lactating).
- Body Mass Index (BMI) 20-40 kg/m2
- Total cholesterol concentration equal to or < 8.0 mmol/l.
- Medications / nutritional supplements allowed, on condition that the subjects adhere to the same regimen during the intervention: anti-hypertensive medication (including beta-blockers), oral contraceptives, hormone replacement therapy, multi-vitamin supplements, other non-fatty acid based nutritional supplements (e.g. garlic, anti-oxidants, etc).
- Smokers and non-smokers.
- Regular consumers of alcohol, which is not excessive as defined by elevated liver enzymes (AST and ALT).
- Ethnicity: Intention to include white Europeans.
Who cannot join
- Diabetes or other endocrine disorders.
- Chronic inflammatory conditions.
- Kidney or liver dysfunction.
- Iron deficiency anaemia (haemoglobin < 12g/dl men, < 11g/dl women)
- Prescribed hypolipidaemic medication
- Prescribed anti-inflammatory medication
Show all 15Show fewer
- Fatty acid supplements including fish oils, evening primrose oil, etc.
- Consumers of high doses of antioxidant vitamins (A, C, E, beta-carotene).
- Red rice yeast (Monascus purpureus) supplement usage.
- High consumers of oily fish (> 2 serving of oily fish per week of herring, mackerel, kippers, pilchards, sardines, salmon, trout, tuna (fresh), crabmeat or marlin). One portion is defined as a small herring or mackerel, one can of salmon or sardines or one salmon or tuna steak. Tinned tuna is permitted as it contains only minor amounts of long chain n-3 PUFAs.
- Highly trained or endurance athletes or those who participate in more than 3 periods of intense exercise per week.
- Volunteers planning to start a special diet or loose weight (e.g. the Slimfast Plan, Atkins Diet etc).
- Weight change equal or >3kg within the last 3 months.
- Alcohol or drug abuse (based on clinical judgement).
- Pregnant / lactating females / women planning a pregnancy in the next 12 months. Women who become pregnant during the dietary intervention period should be removed from the study.
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Nutrigenomics Research Group, Institute of Molecular Medicine, University of Dublin, Trinity College
Dublin, Dublin, 8
About this study
Official title: LIPGENE Dietary Intervention Study
The LIPGENE Human Dietary Intervention Study, multi-centre, trans -European, single-blinded, randomised, controlled trial with two principal aims. Firstly to determine the relative efficacy of reducing dietary SFA consumption, by altering quality of dietary fat and reducing the quantity of dietary fat, on metabolic and molecular risk factors of the metabolic syndrome. Secondly to determine if common genetic polymorphisms affect an individual's responsiveness to dietary therapy.
Read the detailed description
521 free-living subjects with the metabolic syndrome received one of four dietary treatments for 12 weeks: (1) High-fat (38% energy) SFA-rich diet; (2) High-fat (38% energy), MUFA-rich diet; (3) Isocaloric low-fat (28% energy), high-complex carbohydrate diet and (4) Isocaloric low-fat (28% energy), high-complex carbohydrate diet, with 1 g/d LC n-3 PUFA. A 3-day weighed food intake assessed dietary compliance pre-, mid- and post- intervention. An IVGTT, lipoprotein analysis, cytokine, adhesion molecule, coagulation factor and isoprostane levels were determined pre- and post-intervention. DNA, adipose and skeletal muscle biopsies, and PBMC were isolated to characterise nutrient sensitive molecular markers of insulin sensitivity.
- Conditions
- Metabolic Syndrome
- Being tested
- Dietary Fatty Acid Modification
- Keywords
- LIPGENE, Fatty acid, Dietary intervention, Metabolic syndrome, Insulin resistance
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Fatty Acid ModificationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
IVGTT
Lipoprotein metabolism
Cytokine profiles
Coagulation
Fibrinolysis
Oxidative status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2007 (estimated)
- Study startFeb 2004
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 480 participants
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- University of Reading, University of Oslo, Institut National de la Santé Et de la Recherche Médicale, France, Maastricht University Medical Center, Universidad Nacional de Córdoba, Jagiellonian University, Uppsala University
- Investigators
- Helen M Roche, PhD, Study director, University of Dublin, Trinity CollegeChristine Williams, PhD, Principal investigator, University of ReadingChristian Drevon, MD, Principal investigator, University of OsloDenis Larion, PhD, Principal investigator, INSERM, MarseilleWim Saris, PhD, Principal investigator, Maastricht UniversityJose Lopez Miranda, MD, PhD, Principal investigator, Universidad de CórdobaAldona Dembinska-Kiec, MD, Principal investigator, The Jagiellonian University Medical CollegeBengt Vessby, MD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429195
- Sponsor's protocol ID
- LIPGENE Dietary Intervention
- Status last verified
- Jan 2007
- First submitted
- 30 Jan 2007
- Last updated
- 21 Jan 2013
- Results posted
- No
Publications
Camargo A, Rangel-Zuniga OA, Alcala-Diaz J, Gomez-Delgado F, Delgado-Lista J, Garcia-Carpintero S, Marin C, Almaden Y, Yubero-Serrano EM, Lopez-Moreno J, Tinahones FJ, Perez-Martinez P, Roche HM, Lopez-Miranda J. Dietary fat may modulate adipose tissue homeostasis through the processes of autophagy and apoptosis. Eur J Nutr. 2017 Jun;56(4):1621-1628. doi: 10.1007/s00394-016-1208-y. Epub 2016 Mar 30.
PubMed 27029919Yubero-Serrano EM, Delgado-Lista J, Tierney AC, Perez-Martinez P, Garcia-Rios A, Alcala-Diaz JF, Castano JP, Tinahones FJ, Drevon CA, Defoort C, Blaak EE, Dembinska-Kiec A, Riserus U, Lovegrove JA, Perez-Jimenez F, Roche HM, Lopez-Miranda J. Insulin resistance determines a differential response to changes in dietary fat modification on metabolic syndrome risk factors: the LIPGENE study. Am J Clin Nutr. 2015 Dec;102(6):1509-17. doi: 10.3945/ajcn.115.111286. Epub 2015 Nov 11.
PubMed 26561628Delgado-Lista J, Perez-Martinez P, Solivera J, Garcia-Rios A, Perez-Caballero AI, Lovegrove JA, Drevon CA, Defoort C, Blaak EE, Dembinska-Kiec A, Riserus U, Herruzo-Gomez E, Camargo A, Ordovas JM, Roche H, Lopez-Miranda J. Top single nucleotide polymorphisms affecting carbohydrate metabolism in metabolic syndrome: from the LIPGENE study. J Clin Endocrinol Metab. 2014 Feb;99(2):E384-9. doi: 10.1210/jc.2013-3165. Epub 2013 Nov 7.
PubMed 24203067Pena-Orihuela P, Camargo A, Rangel-Zuniga OA, Perez-Martinez P, Cruz-Teno C, Delgado-Lista J, Yubero-Serrano EM, Paniagua JA, Tinahones FJ, Malagon MM, Roche HM, Perez-Jimenez F, Lopez-Miranda J. Antioxidant system response is modified by dietary fat in adipose tissue of metabolic syndrome patients. J Nutr Biochem. 2013 Oct;24(10):1717-23. doi: 10.1016/j.jnutbio.2013.02.012. Epub 2013 May 3.
PubMed 23647888Perez-Martinez P, Garcia-Rios A, Delgado-Lista J, Gjelstad IM, Gibney J, Kiec-Wilk B, Camargo A, Helal O, Karlstrom B, Blaak EE, Hall W, Riserus U, Dembinska-Kiec A, Defoort C, Saris WH, Lovegrove JA, Drevon CA, Roche HM, Lopez-Miranda J. Gene-nutrient interactions on the phosphoenolpyruvate carboxykinase influence insulin sensitivity in metabolic syndrome subjects. Clin Nutr. 2013 Aug;32(4):630-5. doi: 10.1016/j.clnu.2012.10.003. Epub 2012 Oct 8.
PubMed 23092637Camargo A, Rangel-Zuniga OA, Pena-Orihuela P, Marin C, Perez-Martinez P, Delgado-Lista J, Gutierrez-Mariscal FM, Malagon MM, Roche HM, Tinahones FJ, Perez-Jimenez F, Lopez-Miranda J. Postprandial changes in the proteome are modulated by dietary fat in patients with metabolic syndrome. J Nutr Biochem. 2013 Jan;24(1):318-24. doi: 10.1016/j.jnutbio.2012.06.014. Epub 2012 Sep 5.
PubMed 22959058Perez-Martinez P, Perez-Caballero AI, Garcia-Rios A, Yubero-Serrano EM, Camargo A, Gomez-Luna MJ, Marin C, Gomez-Luna P, Dembinska-Kiec A, Rodriguez-Cantalejo F, Tinahones FJ, Roche HM, Perez-Jimenez F, Lopez-Miranda J, Delgado-Lista J. Effects of rs7903146 variation in the Tcf7l2 gene in the lipid metabolism of three different populations. PLoS One. 2012;7(8):e43390. doi: 10.1371/journal.pone.0043390. Epub 2012 Aug 20.
PubMed 22916254van Hees AM, Jocken JW, Essers Y, Roche HM, Saris WH, Blaak EE. Adipose triglyceride lipase and hormone-sensitive lipase protein expression in subcutaneous adipose tissue is decreased after an isoenergetic low-fat high-complex carbohydrate diet in the metabolic syndrome. Metabolism. 2012 Oct;61(10):1404-12. doi: 10.1016/j.metabol.2012.03.017. Epub 2012 Apr 30.
PubMed 22551950Delgado-Lista J, Perez-Martinez P, Garcia-Rios A, Phillips CM, Hall W, Gjelstad IM, Lairon D, Saris W, Kiec-Wilk B, Karlstrom B, Drevon CA, Defoort C, Blaak EE, Dembinska-Kiec A, Riserus U, Lovegrove JA, Roche HM, Lopez-Miranda J. A gene variation (rs12691) in the CCAT/enhancer binding protein alpha modulates glucose metabolism in metabolic syndrome. Nutr Metab Cardiovasc Dis. 2013 May;23(5):417-23. doi: 10.1016/j.numecd.2011.09.008. Epub 2012 Jan 23.
PubMed 22269963Paniagua JA, Perez-Martinez P, Gjelstad IM, Tierney AC, Delgado-Lista J, Defoort C, Blaak EE, Riserus U, Drevon CA, Kiec-Wilk B, Lovegrove JA, Roche HM, Lopez-Miranda J; LIPGENE Study Investigators. A low-fat high-carbohydrate diet supplemented with long-chain n-3 PUFA reduces the risk of the metabolic syndrome. Atherosclerosis. 2011 Oct;218(2):443-50. doi: 10.1016/j.atherosclerosis.2011.07.003. Epub 2011 Jul 12.
PubMed 21839455Jans A, Sparks LM, van Hees AM, Gjelstad IM, Tierney AC, Riserus U, Drevon CA, Roche HM, Schrauwen P, Blaak EE. Transcriptional metabolic inflexibility in skeletal muscle among individuals with increasing insulin resistance. Obesity (Silver Spring). 2011 Nov;19(11):2158-66. doi: 10.1038/oby.2011.149. Epub 2011 Jun 23.
PubMed 21701566Perez-Martinez P, Delgado-Lista J, Garcia-Rios A, Mc Monagle J, Gulseth HL, Ordovas JM, Shaw DI, Karlstrom B, Kiec-Wilk B, Blaak EE, Helal O, Malczewska-Malec M, Defoort C, Riserus U, Saris WH, Lovegrove JA, Drevon CA, Roche HM, Lopez-Miranda J. Glucokinase regulatory protein genetic variant interacts with omega-3 PUFA to influence insulin resistance and inflammation in metabolic syndrome. PLoS One. 2011;6(6):e20555. doi: 10.1371/journal.pone.0020555. Epub 2011 Jun 6.
PubMed 21674002Perez-Martinez P, Delgado-Lista J, Garcia-Rios A, Ferguson JF, Gulseth HL, Williams CM, Karlstrom B, Kiec-Wilk B, Blaak EE, Helal O, Malczewska-Malec M, Defoort C, Riserus U, Saris WH, Lovegrove JA, Drevon CA, Roche HM, Lopez-Miranda J. Calpain-10 interacts with plasma saturated fatty acid concentrations to influence insulin resistance in individuals with the metabolic syndrome. Am J Clin Nutr. 2011 May;93(5):1136-41. doi: 10.3945/ajcn.110.010512. Epub 2011 Mar 9.
PubMed 21389182Jimenez-Gomez Y, Marin C, Peerez-Martinez P, Hartwich J, Malczewska-Malec M, Golabek I, Kiec-Wilk B, Cruz-Teno C, Rodriguez F, Gomez P, Gomez-Luna MJ, Defoort C, Gibney MJ, Perez-Jimenez F, Roche HM, Lopez-Miranda J. A low-fat, high-complex carbohydrate diet supplemented with long-chain (n-3) fatty acids alters the postprandial lipoprotein profile in patients with metabolic syndrome. J Nutr. 2010 Sep;140(9):1595-601. doi: 10.3945/jn.109.120816. Epub 2010 Jul 14.
PubMed 20631323Ferguson JF, Phillips CM, McMonagle J, Perez-Martinez P, Shaw DI, Lovegrove JA, Helal O, Defoort C, Gjelstad IM, Drevon CA, Blaak EE, Saris WH, Leszczynska-Golabek I, Kiec-Wilk B, Riserus U, Karlstrom B, Lopez-Miranda J, Roche HM. NOS3 gene polymorphisms are associated with risk markers of cardiovascular disease, and interact with omega-3 polyunsaturated fatty acids. Atherosclerosis. 2010 Aug;211(2):539-44. doi: 10.1016/j.atherosclerosis.2010.03.027. Epub 2010 Mar 27.
PubMed 20409549
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIPGENE Dietary Intervention Study
- ClinicalTrials.gov ID
- NCT00429195
- Acronym / sponsor ID
- LIPGENE Dietary Intervention
- Conditions
- Metabolic Syndrome
- Keywords
- LIPGENE, Fatty acid, Dietary intervention, Metabolic syndrome, Insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- University of Reading, University of Oslo, Institut National de la Santé Et de la Recherche Médicale, France, Maastricht University Medical Center, Universidad Nacional de Córdoba, Jagiellonian University, Uppsala University
- Study start
- Feb 2004
- Study completion
- Jan 2007
- First posted
- 31 Jan 2007 (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 LIPGENE Human Dietary Intervention Study, multi-centre, trans -European, single-blinded, randomised, controlled trial with two principal aims. Firstly to determine the relative efficacy of reducing dietary SFA consumption, by altering quality of dietary fat and reducing the quantity of dietary fat, on metabolic and molecular risk factors of the metabolic syndrome. Secondly to determine if common genetic polymorphisms affect an individual's responsiveness to dietary therapy.
Detailed description
521 free-living subjects with the metabolic syndrome received one of four dietary treatments for 12 weeks: (1) High-fat (38% energy) SFA-rich diet; (2) High-fat (38% energy), MUFA-rich diet; (3) Isocaloric low-fat (28% energy), high-complex carbohydrate diet and (4) Isocaloric low-fat (28% energy), high-complex carbohydrate diet, with 1 g/d LC n-3 PUFA. A 3-day weighed food intake assessed dietary compliance pre-, mid- and post- intervention. An IVGTT, lipoprotein analysis, cytokine, adhesion molecule, coagulation factor and isoprostane levels were determined pre- and post-intervention. DNA, adipose and skeletal muscle biopsies, and PBMC were isolated to characterise nutrient sensitive molecular markers of insulin sensitivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Gender: males and females (not pregnant or lactating).
- Body Mass Index (BMI) 20-40 kg/m2
- Total cholesterol concentration equal to or < 8.0 mmol/l.
- Medications / nutritional supplements allowed, on condition that the subjects adhere to the same regimen during the intervention: anti-hypertensive medication (including beta-blockers), oral contraceptives, hormone replacement therapy, multi-vitamin supplements, other non-fatty acid based nutritional supplements (e.g. garlic, anti-oxidants, etc).
- Smokers and non-smokers.
Key exclusion criteria (15 listed)
- Diabetes or other endocrine disorders.
- Chronic inflammatory conditions.
- Kidney or liver dysfunction.
- Iron deficiency anaemia (haemoglobin < 12g/dl men, < 11g/dl women)
- Prescribed hypolipidaemic medication
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 |
|---|---|---|
| Dietary Fatty Acid Modification | Behavioural | – |
Primary outcome
IVGTT
Lipoprotein metabolism
Cytokine profiles
Coagulation
Fibrinolysis
Oxidative status
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 21 Jan 2013.
- Derived from this study: PubMed 27029919Camargo A, Rangel-Zuniga OA, Alcala-Diaz J, Gomez-Delgado F, Delgado-Lista J, Garcia-Carpintero S, Marin C, Almaden Y, Yubero-Serrano EM, Lopez-Moreno J, Tinahones FJ, Perez-Martinez P, Roche HM, Lopez-Miranda J. Dietary fat may modulate adipose tissue homeostasis through the processes of autophagy and apoptosis. Eur J Nutr. 2017 Jun;56(4):1621-1628. doi: 10.1007/s00394-016-1208-y. Epub 2016 Mar 30.
- Derived from this study: PubMed 26561628Yubero-Serrano EM, Delgado-Lista J, Tierney AC, Perez-Martinez P, Garcia-Rios A, Alcala-Diaz JF, Castano JP, Tinahones FJ, Drevon CA, Defoort C, Blaak EE, Dembinska-Kiec A, Riserus U, Lovegrove JA, Perez-Jimenez F, Roche HM, Lopez-Miranda J. Insulin resistance determines a differential response to changes in dietary fat modification on metabolic syndrome risk factors: the LIPGENE study. Am J Clin Nutr. 2015 Dec;102(6):1509-17. doi: 10.3945/ajcn.115.111286. Epub 2015 Nov 11.
- Derived from this study: PubMed 24203067Delgado-Lista J, Perez-Martinez P, Solivera J, Garcia-Rios A, Perez-Caballero AI, Lovegrove JA, Drevon CA, Defoort C, Blaak EE, Dembinska-Kiec A, Riserus U, Herruzo-Gomez E, Camargo A, Ordovas JM, Roche H, Lopez-Miranda J. Top single nucleotide polymorphisms affecting carbohydrate metabolism in metabolic syndrome: from the LIPGENE study. J Clin Endocrinol Metab. 2014 Feb;99(2):E384-9. doi: 10.1210/jc.2013-3165. Epub 2013 Nov 7.
- Derived from this study: PubMed 23647888Pena-Orihuela P, Camargo A, Rangel-Zuniga OA, Perez-Martinez P, Cruz-Teno C, Delgado-Lista J, Yubero-Serrano EM, Paniagua JA, Tinahones FJ, Malagon MM, Roche HM, Perez-Jimenez F, Lopez-Miranda J. Antioxidant system response is modified by dietary fat in adipose tissue of metabolic syndrome patients. J Nutr Biochem. 2013 Oct;24(10):1717-23. doi: 10.1016/j.jnutbio.2013.02.012. Epub 2013 May 3.
- Derived from this study: PubMed 23092637Perez-Martinez P, Garcia-Rios A, Delgado-Lista J, Gjelstad IM, Gibney J, Kiec-Wilk B, Camargo A, Helal O, Karlstrom B, Blaak EE, Hall W, Riserus U, Dembinska-Kiec A, Defoort C, Saris WH, Lovegrove JA, Drevon CA, Roche HM, Lopez-Miranda J. Gene-nutrient interactions on the phosphoenolpyruvate carboxykinase influence insulin sensitivity in metabolic syndrome subjects. Clin Nutr. 2013 Aug;32(4):630-5. doi: 10.1016/j.clnu.2012.10.003. Epub 2012 Oct 8.
- Derived from this study: PubMed 22959058Camargo A, Rangel-Zuniga OA, Pena-Orihuela P, Marin C, Perez-Martinez P, Delgado-Lista J, Gutierrez-Mariscal FM, Malagon MM, Roche HM, Tinahones FJ, Perez-Jimenez F, Lopez-Miranda J. Postprandial changes in the proteome are modulated by dietary fat in patients with metabolic syndrome. J Nutr Biochem. 2013 Jan;24(1):318-24. doi: 10.1016/j.jnutbio.2012.06.014. Epub 2012 Sep 5.
- Derived from this study: PubMed 22916254Perez-Martinez P, Perez-Caballero AI, Garcia-Rios A, Yubero-Serrano EM, Camargo A, Gomez-Luna MJ, Marin C, Gomez-Luna P, Dembinska-Kiec A, Rodriguez-Cantalejo F, Tinahones FJ, Roche HM, Perez-Jimenez F, Lopez-Miranda J, Delgado-Lista J. Effects of rs7903146 variation in the Tcf7l2 gene in the lipid metabolism of three different populations. PLoS One. 2012;7(8):e43390. doi: 10.1371/journal.pone.0043390. Epub 2012 Aug 20.
- Derived from this study: PubMed 22551950van Hees AM, Jocken JW, Essers Y, Roche HM, Saris WH, Blaak EE. Adipose triglyceride lipase and hormone-sensitive lipase protein expression in subcutaneous adipose tissue is decreased after an isoenergetic low-fat high-complex carbohydrate diet in the metabolic syndrome. Metabolism. 2012 Oct;61(10):1404-12. doi: 10.1016/j.metabol.2012.03.017. Epub 2012 Apr 30.
- Derived from this study: PubMed 22269963Delgado-Lista J, Perez-Martinez P, Garcia-Rios A, Phillips CM, Hall W, Gjelstad IM, Lairon D, Saris W, Kiec-Wilk B, Karlstrom B, Drevon CA, Defoort C, Blaak EE, Dembinska-Kiec A, Riserus U, Lovegrove JA, Roche HM, Lopez-Miranda J. A gene variation (rs12691) in the CCAT/enhancer binding protein alpha modulates glucose metabolism in metabolic syndrome. Nutr Metab Cardiovasc Dis. 2013 May;23(5):417-23. doi: 10.1016/j.numecd.2011.09.008. Epub 2012 Jan 23.
- Derived from this study: PubMed 21839455Paniagua JA, Perez-Martinez P, Gjelstad IM, Tierney AC, Delgado-Lista J, Defoort C, Blaak EE, Riserus U, Drevon CA, Kiec-Wilk B, Lovegrove JA, Roche HM, Lopez-Miranda J; LIPGENE Study Investigators. A low-fat high-carbohydrate diet supplemented with long-chain n-3 PUFA reduces the risk of the metabolic syndrome. Atherosclerosis. 2011 Oct;218(2):443-50. doi: 10.1016/j.atherosclerosis.2011.07.003. Epub 2011 Jul 12.
- Derived from this study: PubMed 21701566Jans A, Sparks LM, van Hees AM, Gjelstad IM, Tierney AC, Riserus U, Drevon CA, Roche HM, Schrauwen P, Blaak EE. Transcriptional metabolic inflexibility in skeletal muscle among individuals with increasing insulin resistance. Obesity (Silver Spring). 2011 Nov;19(11):2158-66. doi: 10.1038/oby.2011.149. Epub 2011 Jun 23.
- Derived from this study: PubMed 21674002Perez-Martinez P, Delgado-Lista J, Garcia-Rios A, Mc Monagle J, Gulseth HL, Ordovas JM, Shaw DI, Karlstrom B, Kiec-Wilk B, Blaak EE, Helal O, Malczewska-Malec M, Defoort C, Riserus U, Saris WH, Lovegrove JA, Drevon CA, Roche HM, Lopez-Miranda J. Glucokinase regulatory protein genetic variant interacts with omega-3 PUFA to influence insulin resistance and inflammation in metabolic syndrome. PLoS One. 2011;6(6):e20555. doi: 10.1371/journal.pone.0020555. Epub 2011 Jun 6.
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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.
Helen M Roche, PhD study director
University of Dublin, Trinity College
Christine Williams, PhD principal investigator
University of Reading
Christian Drevon, MD principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Fatty Acid Modification in people with Metabolic Syndrome, run by University College Dublin at 1 site in Ireland.
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 7 inclusion and 15 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 21 Jan 2013. 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 Ireland. 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. 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?
IVGTT. The study lists 6 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 NCT00429195, which also lists 18 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 21 Jan 2013.