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Study Title and Description

Alimentary habits, physical activity, and Framingham global risk score in metabolic syndrome.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Alimentary habits, physical activity, and Framingham global risk score in metabolic syndrome.
Author Soares TS., Piovesan CH., Gustavo Ada S., Macagnan FE., Bodanese LC., Feoli AM.
Country -- Not Found --
Year 2014
Numbers Pubmed ID: 24652053
16820 (internal)

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 Placebo dietary intervention and placebo
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2 "Fish oil" (DHA+EPA) dietary intervention and Omega 3 supplementation
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3 Placebo dietary intervention and placebo and exercise
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4 "Fish oil" (DHA+EPA) dietary intervention and Omega 3 and exercise
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Factorial Design
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Country in which study conducted (where subjects live) ... Specify Other(s) [Separate countries with commas]: ... Brazil
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Funding source No industry relationship reported (funding or affiliations reported)
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Eligibility Criteria: The participants included men and women aged between 30 and 60 years who exhibited three or more of the findings indicated by the National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III): an abdominal circumference (AC) of > 88 cm for women and > 102 cm for men, a systolic arterial pressure (SAP) of ≥ 130 mmHg and a diastolic arterial pressure of ≥ 85 mmHg, a fasting glucose level of ≥ 100 mg/dL, a triglyceride level of ≥150 mg/dL, and a high-density lipoprotein cholesterol (HDL-C) level of < 40 mg/dL for men and < 50 mg/dL for women. Patients with absolute contraindications for physical activity because of musculoskeletal, neurological, vascular, pulmonary, and cardiac problems; those on lipid-lowering medication; those on anticoagulant medication; those who exercised regularly (30 min twice a week or more); those with a psychiatric disorder; those on antidepressant medication; those diagnosed hypothyroidism; pregnant patients; those consuming omega 3 supplements or any other food or vitamin supplements; and those who were difficult to contact and/or were lost to follow-up were excluded
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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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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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Hypertension ... systolic arterial pressure (SAP) of ≥ 130 mmHg and a diastolic arterial pressure of ≥ 85 mmHg
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Dyslipidemia ... a triglyceride level of ≥150 mg/dL, and a high-density lipoprotein cholesterol (HDL-C) level of < 40 mg/dL for men and < 50 mg/dL for women
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Obesity/Overweight ... abdominal circumference (AC) of > 88 cm for women and > 102 cm for men
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Conflict of interest No conflict of interest (explicitly stated)
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Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... sex, exercise
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Does the study report a regression analysis with interaction terms for an outcome of interest? No
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Does the study report an analysis of the association between n-3 biomarkers and an outcome of interest? No
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Study start date(s) 2011
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Baseline Characteristics
Question Placebo "Fish oil" (DHA+EPA) Placebo "Fish oil" (DHA+EPA) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions No data entered.
Baseline characteristics, continuous 51.6 52 50.8 51
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13.4 12.5 13.4 14.7
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134.4 130.2 131.1 131.6
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35.1 31.7 36.6 36.3
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85.3 83.9 84.3 78.2
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21.2 23.1 22.4 20.3
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nd nd nd nd
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nd nd nd nd
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nd nd nd nd
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47.3 44.65 45.7 40.8
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mg/dL mg/dL mg/dL mg/dL
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14.1 14.9 15.7 12.3
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199.6 193.8 194.5 198.6
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mg/dL mg/dL mg/dL mg/dL
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126.3 93.2 96.3 76.3
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32.8 34.1 32.3 33.5
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8.1 7.9 8.9 8.6
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Male, percent 28.6
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Race nd
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Comments about baseline data No data entered.
Baseline diet description The dietary intervention included an eating plan, which was given to the patients during the first consultation. The eating plan was based on the recommendations of the First Brazilian Guideline for the Diagnosis and Treatment of Metabolic Syndrome (I DBSM)1, which recommends the following composition: total calories, to reduce weight by 5% to 10%; carbohydrates, 50% to 60% of total calories, with an emphasis on complex carbohydrates; fibers, 20 to 30 g/day; total fat, 25% to 35% of total calories; saturated fatty acids, < 10% of total calories; polyunsaturated fatty acids, up to 10% of total calories; monounsaturated fatty acids, up to 20% of total calories; cholesterol, < 300 mg/day; proteins, 0.8 g to 1.0 g/kg current weight/day or 15% of total calories; micronutrients, in accordance with the recommendations of the Dietary Reference Intakes (DRIs), with an emphasis on antioxidants. The dietary intervention included an eating plan, which was given to the patients during the first consultation. The eating plan was based on the recommendations of the First Brazilian Guideline for the Diagnosis and Treatment of Metabolic Syndrome (I DBSM)1, which recommends the following composition: total calories, to reduce weight by 5% to 10%; carbohydrates, 50% to 60% of total calories, with an emphasis on complex carbohydrates; fibers, 20 to 30 g/day; total fat, 25% to 35% of total calories; saturated fatty acids, < 10% of total calories; polyunsaturated fatty acids, up to 10% of total calories; monounsaturated fatty acids, up to 20% of total calories; cholesterol, < 300 mg/day; proteins, 0.8 g to 1.0 g/kg current weight/day or 15% of total calories; micronutrients, in accordance with the recommendations of the Dietary Reference Intakes (DRIs), with an emphasis on antioxidants. The dietary intervention included an eating plan, which was given to the patients during the first consultation. The eating plan was based on the recommendations of the First Brazilian Guideline for the Diagnosis and Treatment of Metabolic Syndrome (I DBSM)1, which recommends the following composition: total calories, to reduce weight by 5% to 10%; carbohydrates, 50% to 60% of total calories, with an emphasis on complex carbohydrates; fibers, 20 to 30 g/day; total fat, 25% to 35% of total calories; saturated fatty acids, < 10% of total calories; polyunsaturated fatty acids, up to 10% of total calories; monounsaturated fatty acids, up to 20% of total calories; cholesterol, < 300 mg/day; proteins, 0.8 g to 1.0 g/kg current weight/day or 15% of total calories; micronutrients, in accordance with the recommendations of the Dietary Reference Intakes (DRIs), with an emphasis on antioxidants. The dietary intervention included an eating plan, which was given to the patients during the first consultation. The eating plan was based on the recommendations of the First Brazilian Guideline for the Diagnosis and Treatment of Metabolic Syndrome (I DBSM)1, which recommends the following composition: total calories, to reduce weight by 5% to 10%; carbohydrates, 50% to 60% of total calories, with an emphasis on complex carbohydrates; fibers, 20 to 30 g/day; total fat, 25% to 35% of total calories; saturated fatty acids, < 10% of total calories; polyunsaturated fatty acids, up to 10% of total calories; monounsaturated fatty acids, up to 20% of total calories; cholesterol, < 300 mg/day; proteins, 0.8 g to 1.0 g/kg current weight/day or 15% of total calories; micronutrients, in accordance with the recommendations of the Dietary Reference Intakes (DRIs), with an emphasis on antioxidants.
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Baseline omega-3 intake nd
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Does this study report baseline omega-3 biomarker data? No
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Results & Comparisons


Results Data
Outcome: bp      Population: 51827
Time Point Measure Placebo "Fish oil" (DHA+EPA) Placebo "Fish oil" (DHA+EPA)


0 months

N Analyzed 18 20 15 17
Mean 134.4 130.2 131.1 131.6
SD 3.8 3.6 4.2 3.9


3 months

N Analyzed 18 20 15 17
Mean 127.0 123.4 122.4 126.7
SD 2.9 2.8 3.2 3.0
SE
Outcome: lipid      Population: 51829
Time Point Measure Placebo "Fish oil" (DHA+EPA) Placebo "Fish oil" (DHA+EPA)


0 months

N Analyzed
Mean
SD


3 months

N Analyzed
Mean
SD
Outcome: lipid      Population: 51829
Time Point Measure Placebo "Fish oil" (DHA+EPA) Placebo "Fish oil" (DHA+EPA)


0 months

N Analyzed 18 17 13 17
Mean 48.5 48.6 48.1 44.1
SD 2.2 3.1 3.2 2.4


3 months

N Analyzed 13 15 11 13
Mean 47.0 46.2 45.0 48.6
SD 3.1 2.3 2.1 3.4
Outcome: lipid      Population: 51829
Time Point Measure Placebo "Fish oil" (DHA+EPA) Placebo "Fish oil" (DHA+EPA)


0 months

N Analyzed 6 6 4 6
Mean 43.0 37.3 36.0 34.8
SD 6.5 3.7 3.5 2.1


3 months

N Analyzed 5 5 4 4
Mean 40.0 36.0 32.7 40.8
SD 4.8 3.1 0.3 8.3

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? UNCLEAR
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Was ALLOCATION adequately concealed (prior to assignment)? UNCLEAR
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Were PARTICIPANTS adequately BLINDED? LOW
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Were OUTCOME ASSESSORS adequately BLINDED? UNCLEAR
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Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data LOW
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Is there evidence of SELECTIVE OUTCOME REPORTING bias (Yes/No)? Yes baselines for tg, dbp given, but no followup values given
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INTENTION-TO-TREAT analysis? (Yes/No) No Only completers analyzed
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Group SIMILARITY AT BASELINE (**GENERAL**) LOW
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Was there incomplete COMPLIANCE with interventions across groups? UNCLEAR
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Group SIMILARITY AT BASELINE (**OMEGA-3**) UNCLEAR
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Additional Bias: Bias due to problems not covered elsewhere in the table.
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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
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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
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Quality Rating
No quality rating data was found.