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Study Title and Description

Effects of dietary fat modification on insulin sensitivity and on other risk factors of the metabolic syndrome--LIPGENE: a European randomized dietary intervention study.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Effects of dietary fat modification on insulin sensitivity and on other risk factors of the metabolic syndrome--LIPGENE: a European randomized dietary intervention study.
Author Tierney AC., McMonagle J., Shaw DI., Gulseth HL., Helal O., Saris WH., Paniagua JA., Gołąbek-Leszczyñska I., Defoort C., Williams CM., Karsltröm B., Vessby B., Dembinska-Kiec A., López-Miranda J., Blaak EE., Drevon CA., Gibney MJ., Lovegrove JA., Roche HM.
Country Nutrigenomics Research Group, UCD Conway Institute & UCD Institute of Food & Health, University College Dublin, Belfield, Dublin 4, Ireland.
Year 2011
Numbers Pubmed ID: 20938439
14782 (internal)

Secondary Publication Information
UI Title Author Country Year
A low-fat high-carbohydrate diet supplemented with long-chain n-3 PUFA reduces the risk of the metabolic syndrome. Paniagua JA., Pérez-Martinez P., Gjelstad IM., Tierney AC., Delgado-Lista J., Defoort C., Blaak EE., Risérus U., Drevon CA., Kiec-Wilk B., Lovegrove JA., Roche HM., López-Miranda J. Reina Sofia University Hospital, University of Cordoba, Cordoba, Spain. japaniaguag@yahoo.es 2011
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Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 Low n-3 diet LFHCC
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2 "Fish oil" (DHA+EPA) LFHCC n-3 (only diet with added n-3 supplement)
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Parallel (Omega-3 vs. Control; Omega-3 + X vs. X)
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What is the name of this study? (e.g. DART, Physician's Health Study) LIPGENE
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Country in which study conducted (where subjects live) Netherlands
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Norway
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Sweden
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UK
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Other(s) [Separate countries with commas]: ... Ireland, France, Poland, Spain
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Funding source Authors report industry affiliation
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Eligibility Criteria: 3-5 characteristics of Metabolic Syndrome (see Comment about Eligibility Criteria)
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Comment about Eligibility Criteria: 1. fasting glucose conc 5.5-7 mmol/l, 2. serum TAG >1/5 mmol/l, 3. serum HDL conc <1.0 mmol/L (men) or <1.3 mmol/L (women), 4. BP : sysolic >130 mm Hg, diastolic BP >85 mm , 5. Waist girth >102 cm(men) or >88 cm (women)
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Study Population Primary Prevention, Increased CVD Risk (ie, diabetes, metabolic syndrome*, hypertension, dyslipidemia, or chronic kidney disease)
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Comment about study design: Full trial has 4 diets: high saturated fatty acids, high mono-unsaturated fatty acids, low fat, high-complex carbohydrate with n-3, low fat, high-complex carbohydrate with placebo
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Duration of Intervention 3 months
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At baseline, did all subjects have (per eligibility criteria)...? Diabetes and/or metabolic syndrome*
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Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... low (below median) or high (above median) fat-intake ; excluding lowest and highest 5%
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Study start date(s) 2004
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Baseline Characteristics
Question Low n-3 diet "Fish oil" (DHA+EPA) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 100 100 100
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Baseline characteristics, continuous 54.70 55.39 nd
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0.91 0.96 nd
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139.53 137.73 nd
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1.46 1.52 nd
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85.50 85.52 nd
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0.87 0.91 nd
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91.96 91.20 nd
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Kg Kg nd
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1.38 1.43 nd
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mmol/L mmol/L nd
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mmol/L mmol/L
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mmol/L mmol/L
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1.67 1.68
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mmol/L mmol/L
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0.10 0.11
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32.51 32.42
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0.42 0.43
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nd nd
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5.22 5.38
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0.10 0.11
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3.17 3.31
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0.11 0.12
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1.09 1.11
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0.03 0.03
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Male, percent nd nd 80
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Race nd nd nd
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Comments about baseline data No data entered.
Baseline diet description nd nd
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Baseline omega-3 intake 1.63 1.46
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Does this study report baseline omega-3 biomarker data? No data entered.



Results & Comparisons


Results Data
Outcome: lipid      Population: 45535
Time Point Measure Low n-3 diet "Fish oil" (DHA+EPA)


3 months

N Analyzed 77 83
Prevalence 51.9 37.8
N with condition 40 31


0 months

N Analyzed 77 83
Prevalence 53.2 50.6
N with condition 41 42
Outcome: bp      Population: 44415
Time Point Measure Low n-3 diet "Fish oil" (DHA+EPA)


0 months

N Analyzed 106 100
Mean 85.50 85.52
SE 0.87 0.91


3 months

N Analyzed 106 100
Mean 83.64 82.94
SE 0.84 0.87
Outcome: bp      Population: 44416
Time Point Measure Low n-3 diet "Fish oil" (DHA+EPA)


0 months

N Analyzed 106 100
Mean 139.53 137.73
SE 1.46 1.52


3 months

N Analyzed 106 100
Mean 135.18 133.52
SE 1.44 1.50
Outcome: lipid      Population: 44460
Time Point Measure Low n-3 diet "Fish oil" (DHA+EPA)


0 months

N Analyzed 106 100
Mean 1.09 1.11
SE 0.03 0.03


3 months

N Analyzed 106 100
Mean 1.08 1.12
SE 0.03 0.03
Outcome: lipid      Population: 44461
Time Point Measure Low n-3 diet "Fish oil" (DHA+EPA)


0 months

N Analyzed 106 100
Mean 3.17 3.31
SE 0.11 0.12


3 months

N Analyzed 106 100
Mean 3.09 3.09
SE 0.11 0.12
Outcome: lipid      Population: 44462
Time Point Measure Low n-3 diet "Fish oil" (DHA+EPA)


0 months

N Analyzed 106 100
Mean 1.67 1.68
SE 0.10 0.11


3 months

N Analyzed 106 100
Mean 1.78 1.57
SE 0.09 0.10

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
Low n-3 diet Adverse Event 1 No adverse events described in study nd nd nd
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"Fish oil" (DHA+EPA) nd nd nd

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? Low Randomization was completed centrally = adequate allocation concealment.
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Was ALLOCATION adequately concealed (prior to assignment)? Low
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Were PARTICIPANTS adequately BLINDED? High Diet trials cannot be blinded
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Were OUTCOME ASSESSORS adequately BLINDED? Low
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Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data Low some 69 volunteers dropped out immediately after the initial preintervention clinical investigation and did not proceed with the dietary interven- tion;
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Is there evidence of SELECTIVE OUTCOME REPORTING bias (Yes/No)? Low
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INTENTION-TO-TREAT analysis? (Yes/No) Yes
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Group SIMILARITY AT BASELINE (**GENERAL**) Low
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Was there incomplete COMPLIANCE with interventions across groups? Low
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Group SIMILARITY AT BASELINE (**OMEGA-3**) Low
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Additional Bias: Bias due to problems not covered elsewhere in the table. No
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If outcome assessor blinding risk of bias is different for different outcomes (eg, lipids vs. MI), choose HIGH risk of bias and describe in Notes Low
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If attrition risk of bias is different for different outcomes (eg, lipids vs. MI) or different time points (eg, 1 year vs. 5 years), choose HIGH risk of bias and describe in Notes Low
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Quality Rating
No quality rating data was found.