Study title
LIPGENE: European randomized dietary intervention study
Template
Intervention/Observation study
title
LIPGENE: European randomized dietary intervention study
description
EU FP6 Integrated Programme conducted by a Consortium of 25 European research centres (2004-2009) Contract: FOOD-CT-2003-505944. Intervention study conducted by 8 centres. Subjects receive 1 of 4 Diets; A high fat SFA rich diet (HSFA), A high-fat MUFA-rich diet (HMUFA), An isoenergetic low-fat high complex carbohydrate Diet (LFHCC), An isoenergetic low-fat, high-complex carbohydrate diet with VLC n-3 PUFA (LFHCC n-3)
startDate
2004-01-01 00:00:00.0
Study type
Human Intervention
Principle Investigator
PROF. HELEN ROCHE (UCD, Dublin)
Objectives
LIPGENE was a pan-European, multicentre dietary intervention study with 500 subjects designed to determine the relative efficacy of altering the quality and quantity of dietary fat on insulin sensitivity and metabolic risk factors associated with the Metabolic Syndrome. This was an isoenergetic intervention to exclude the effects of weight change.
Exclusion criteria
Age: < 35 or >70years
Diabetes or other endocrine disorders (Diabetes (Type 1 and 2), Hypothyroidism, Hyperthyroidism, Adrenal disorders, Addisons Disease, Cushings Disease, Pheochromocytomas, Mulitiple Endocrine Neoplasia (MENS), other rare conditions as encountered)
Chronic inflammatory conditions (Inflammatory Bowel Disease, Crohn’s Disease, Ulcerative Colitis, Rheumatoid Arthritis, Lupus, Atopic Dermatitis, Psoriasis, Coeliac Disease, Fibromyalgia, Pelvic Inflammatory Disease, Endometriosis, Asthma (on regular anti inflammatory medication), other rare conditions encountered)
Kidney or liver dysfunction.
Iron deficiency anaemia (haemoglobin < 12g/dl men, < 11g/dl women)
Prescribed hypolipidaemic medication1
Prescribed anti-inflammatory medication
Fatty acid supplements including fish oils, evening primrose oil, etc.
Consumers of high doses of antioxidant vitamins (A, C, E, -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 low amounts of n-3 PUFA.
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.
Inclusion criteria
Age: 35 -70 years
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 adhered 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
Smokers and non-smokers.
Regular consumers of alcohol, which was not excessive as defined by AST/ALT
Ethnicity: Intention to include white Europeans.
Institute
Eight intervention centres
UCD Dublin Ireland
Reading, UK
Oslo, Norway
Marseille, France
Maastricht, The Netherlands
Cordoba, Spain
Krakow, Poland
Uppsala, Sweden
Collaborators involved
PROF. MIKE GIBNEY, Dr. CATHERINE PHILLIPS
Diet short codes and descriptions
