This is the old version of SRDR. The next, SRDRplus is available! Registration of your SRDRPlus account is free and approval is automatic. Click Here to register an SRDRPlus account.

Advanced Search

Study Preview



Study Title and Description

Effects of omega-3 on metabolic markers in postmenopausal women with metabolic syndrome.



Key Questions Addressed
1 RCTs and other Comparative studies
  • Comments Comments (
    0
    ) |

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title Effects of omega-3 on metabolic markers in postmenopausal women with metabolic syndrome.
Author Tardivo AP., Nahas-Neto J., Orsatti CL., Dias FB., Poloni PF., Schmitt EB., Nahas EA.
Country Department of Gynecology and Obstetrics, Botucatu Medicine School, Sao Paulo State University - UNESP , São Paulo , Brazil.
Year 2015
Numbers Pubmed ID: 25394692

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


Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 "Fish oil" (DHA+EPA) omega-3 + diet
  • Comments Comments (
    0
    ) |
2 Placebo diet
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Parallel (Omega-3 vs. Control; Omega-3 + X vs. X)
  • Comments Comments (
    0
    ) |
Country in which study conducted (where subjects live) ... Specify Other(s) [Separate countries with commas]: ... Brazil
  • Comments Comments (
    0
    ) |
Funding source Industry funded
  • Comments Comments (
    0
    ) |
Eligibility Criteria: Women tho had their last menstruation at least 12 months prior to this study, aged >= 45 years old and with three or more diagnostic criteria for MetS were included in the study. Exclusion criteria were: known high cardiovascular risk due to existing or pre-existing CHD, CAD, abdominal aortic stenosis or aneurysm, peripheral artery disease, chronic kidney disease, insulin-dependent diabetes; use of medications (statins, hormone therapy); history of liver disease, infection, chronic inflammatory disease, autoimmune diseases, cancer; intolerance or good allergy to fish.
  • Comments Comments (
    0
    ) |
Study Population Primary Prevention, Healthy
  • Comments Comments (
    0
    ) |
Duration of Intervention 6 months
  • Comments Comments (
    0
    ) |
Conflict of interest ... Specify Conflict of interest stated ... The authors declare that there are no relevant conflicts of interest, nor commercial, no proprietary, nor financial in the products or instruments described in this artcile.
  • Comments Comments (
    0
    ) |
Does the study report a subgroup analysis for an outcome of interest? No
  • Comments Comments (
    0
    ) |
Does the study report a regression analysis with interaction terms for an outcome of interest? No
  • Comments Comments (
    0
    ) |
Does the study report an analysis of the association between n-3 biomarkers and an outcome of interest? No
  • Comments Comments (
    0
    ) |


Baseline Characteristics
Question "Fish oil" (DHA+EPA) Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions No data entered.
Baseline characteristics, continuous 55.1 55.0
  • Comments Comments (
    0
    ) |
skip skip
  • Comments Comments (
    0
    ) |
6.6 7.3
  • Comments Comments (
    0
    ) |
138.8 135.5
  • Comments Comments (
    0
    ) |
skip skip
  • Comments Comments (
    0
    ) |
14.4 12.1
  • Comments Comments (
    0
    ) |
86.2 85.3
  • Comments Comments (
    0
    ) |
skip skip
  • Comments Comments (
    0
    ) |
8.8 6.9
  • Comments Comments (
    0
    ) |
nd nd
  • Comments Comments (
    0
    ) |
219.1 221.5
  • Comments Comments (
    0
    ) |
mg/dL mg/dL
  • Comments Comments (
    0
    ) |
33.2 39.3
  • Comments Comments (
    0
    ) |
134.8 134.3
  • Comments Comments (
    0
    ) |
mg/dL mg/dL
  • Comments Comments (
    0
    ) |
29.6 35.0
  • Comments Comments (
    0
    ) |
45.9 44.6
  • Comments Comments (
    0
    ) |
mg/dL mg/dL
  • Comments Comments (
    0
    ) |
6.2 8.2
  • Comments Comments (
    0
    ) |
192.5 188.6
  • Comments Comments (
    0
    ) |
mg/dL mg/dL
  • Comments Comments (
    0
    ) |
65.4 57.4
  • Comments Comments (
    0
    ) |
32.8 32.0
  • Comments Comments (
    0
    ) |
skip skip
  • Comments Comments (
    0
    ) |
4.7 4.6
  • Comments Comments (
    0
    ) |
nd nd
  • Comments Comments (
    0
    ) |
Male, percent 0% 0%
  • Comments Comments (
    0
    ) |
Race 100 100
  • Comments Comments (
    0
    ) |
Comments about baseline data No data entered.
Baseline diet description No data entered.
Baseline omega-3 intake linolenic acid 1.6 mg linolenic acid 1.7
  • Comments Comments (
    0
    ) |
Does this study report baseline omega-3 biomarker data? No No
  • Comments Comments (
    0
    ) |



Results & Comparisons

No Results found.
Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
"Fish oil" (DHA+EPA)
  • Comments Comments (
    0
    ) |
Placebo

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? LOW
  • Comments Comments (
    0
    ) |
Was ALLOCATION adequately concealed (prior to assignment)? UNCLEAR
  • Comments Comments (
    0
    ) |
Were PARTICIPANTS adequately BLINDED? HIGH no mention of blinding
  • Comments Comments (
    0
    ) |
Were OUTCOME ASSESSORS adequately BLINDED? HIGH no mention of blinding
  • Comments Comments (
    0
    ) |
Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data HIGH missed follow-up, no blood collection, discontinued omega-3
  • Comments Comments (
    0
    ) |
Is there evidence of SELECTIVE OUTCOME REPORTING bias (Yes/No)? No
  • Comments Comments (
    0
    ) |
INTENTION-TO-TREAT analysis? (Yes/No) Unsure
  • Comments Comments (
    0
    ) |
Group SIMILARITY AT BASELINE (**GENERAL**) LOW
  • Comments Comments (
    0
    ) |
Was there incomplete COMPLIANCE with interventions across groups? UNCLEAR
  • Comments Comments (
    0
    ) |
Group SIMILARITY AT BASELINE (**OMEGA-3**) LOW
  • Comments Comments (
    0
    ) |
Additional Bias: Bias due to problems not covered elsewhere in the table. No
  • Comments Comments (
    0
    ) |
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
  • Comments Comments (
    0
    ) |
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
  • Comments Comments (
    0
    ) |

Quality Rating
No quality rating data was found.