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

Primary Purpose

Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

Ireland

Study Type

Interventional

Intervention

Dietary Fatty Acid Modification

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring LIPGENE, Fatty acid, Dietary intervention, Metabolic syndrome, Insulin resistance

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Outcomes

Primary Outcome Measures

IVGTT

Lipoprotein metabolism

Cytokine profiles

Coagulation

Fibrinolysis

Oxidative status

Secondary Outcome Measures

Full Information

NCT ID

NCT00429195

First Posted

January 30, 2007

Last Updated

January 18, 2013

Sponsor

University College Dublin

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

1. Study Identification

Unique Protocol Identification Number

NCT00429195

Brief Title

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

Official Title

LIPGENE Dietary Intervention Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2007

Overall Recruitment Status

Completed

Study Start Date

February 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University College Dublin

Collaborators

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

Keywords

LIPGENE, Fatty acid, Dietary intervention, Metabolic syndrome, Insulin resistance

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Single

Allocation

Randomized

Enrollment

480 (false)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

Dietary Fatty Acid Modification

Primary Outcome Measure Information:

Title

IVGTT

Title

Lipoprotein metabolism

Title

Cytokine profiles

Title

Coagulation

Title

Fibrinolysis

Title

Oxidative status

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: