The Effect of Dietary Fat Modification on Risk Factors Associated With the Metabolic Syndrome

January 18, 2013 updated by: University College Dublin

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

480

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland, 8
        • Nutrigenomics Research Group, Institute of Molecular Medicine, University of Dublin, Trinity College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
IVGTT
Lipoprotein metabolism
Cytokine profiles
Coagulation
Fibrinolysis
Oxidative status

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College Dublin

Collaborators

University of Oslo
Uppsala University
Institut National de la Santé Et de la Recherche Médicale, France
Maastricht University Medical Center
Jagiellonian University
University of Reading
Universidad Nacional de Córdoba

Investigators

  • Study Director: Helen M Roche, PhD, University of Dublin, Trinity College
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Study Completion

January 1, 2007

Study Registration Dates

First Submitted

January 30, 2007

First Submitted That Met QC Criteria

January 30, 2007

First Posted (Estimate)

January 31, 2007

Study Record Updates

Last Update Posted (Estimate)

January 21, 2013

Last Update Submitted That Met QC Criteria

January 18, 2013

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIPGENE Dietary Intervention

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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