NCT00429195

Brief 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 and molecular risk factors of the metabolic syndrome. Secondly to determine if common genetic polymorphisms affect an individual's responsiveness to dietary therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
480

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2004

Typical duration for not_applicable

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

February 1, 2004

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2007

Completed
Last Updated

January 21, 2013

Status Verified

January 1, 2007

First QC Date

January 30, 2007

Last Update Submit

January 18, 2013

Conditions

Metabolic Syndrome

Keywords

LIPGENEFatty acidDietary interventionMetabolic syndromeInsulin resistance

Outcome Measures

Primary Outcomes (6)

  • IVGTT

  • Lipoprotein metabolism

  • Cytokine profiles

  • Coagulation

  • Fibrinolysis

  • Oxidative status

Interventions

Dietary Fatty Acid ModificationBEHAVIORAL

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrigenomics Research Group, Institute of Molecular Medicine, University of Dublin, Trinity College

Dublin, Dublin, 8, Ireland

Location

Related Publications (18)

  • 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.

    PMID: 27029919DERIVED

  • Yubero-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.

    PMID: 26561628DERIVED

  • Delgado-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.

    PMID: 24203067DERIVED

  • Pena-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.

    PMID: 23647888DERIVED

  • Perez-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.

    PMID: 23092637DERIVED

  • Camargo 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.

    PMID: 22959058DERIVED

  • Perez-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.

    PMID: 22916254DERIVED

  • van 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.

    PMID: 22551950DERIVED

  • Delgado-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.

    PMID: 22269963DERIVED

  • Paniagua 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.

    PMID: 21839455DERIVED

  • Jans 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.

    PMID: 21701566DERIVED

  • Perez-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.

    PMID: 21674002DERIVED

  • Perez-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.

    PMID: 21389182DERIVED

  • Jimenez-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.

    PMID: 20631323DERIVED

  • Ferguson 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.

    PMID: 20409549DERIVED

  • van Hees AM, Saris WH, Hul GB, Schaper NC, Timmerman BE, Lovegrove JA, Roche HM, Blaak EE. Effects of dietary fat modification on skeletal muscle fatty acid handling in the metabolic syndrome. Int J Obes (Lond). 2010 May;34(5):859-70. doi: 10.1038/ijo.2010.6. Epub 2010 Feb 2.

    PMID: 20125104DERIVED

  • Ferguson JF, Phillips CM, Tierney AC, Perez-Martinez P, Defoort C, Helal O, Lairon D, Planells R, Shaw DI, Lovegrove JA, Gjelstad IM, Drevon CA, Blaak EE, Saris WH, Leszczynska-Golabek I, Kiec-Wilk B, Riserus U, Karlstrom B, Miranda JL, Roche HM. Gene-nutrient interactions in the metabolic syndrome: single nucleotide polymorphisms in ADIPOQ and ADIPOR1 interact with plasma saturated fatty acids to modulate insulin resistance. Am J Clin Nutr. 2010 Mar;91(3):794-801. doi: 10.3945/ajcn.2009.28255. Epub 2009 Dec 23.

    PMID: 20032495DERIVED

  • Hartwich J, Malec MM, Partyka L, Perez-Martinez P, Marin C, Lopez-Miranda J, Tierney AC, Mc Monagle J, Roche HM, Defoort C, Wolkow P, Dembinska-Kiec A. The effect of the plasma n-3/n-6 polyunsaturated fatty acid ratio on the dietary LDL phenotype transformation - insights from the LIPGENE study. Clin Nutr. 2009 Oct;28(5):510-5. doi: 10.1016/j.clnu.2009.04.016. Epub 2009 May 28.

    PMID: 19481310DERIVED

MeSH Terms

Conditions

Metabolic SyndromeInsulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Helen M Roche, PhD

    University of Dublin, Trinity College

    STUDY DIRECTOR

  • Christine Williams, PhD

    University of Reading

    PRINCIPAL INVESTIGATOR

  • Christian Drevon, MD

    University of Oslo

    PRINCIPAL INVESTIGATOR

  • Denis Larion, PhD

    INSERM, Marseille

    PRINCIPAL INVESTIGATOR

  • Wim Saris, PhD

    Maastricht University

    PRINCIPAL INVESTIGATOR

  • Jose Lopez Miranda, MD, PhD

    Universidad de Córdoba

    PRINCIPAL INVESTIGATOR

  • Aldona Dembinska-Kiec, MD

    The Jagiellonian University Medical College

    PRINCIPAL INVESTIGATOR

  • Bengt Vessby, MD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 30, 2007

First Posted

January 31, 2007

Study Start

February 1, 2004

Study Completion

January 1, 2007

Last Updated

January 21, 2013

Record last verified: 2007-01

Locations

IE(1)