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Effect of Diet and Omega-3 Supplementation on Markers of Risk for Heart Disease in Postmenopausal Women

Impact of Dietary Adequacy and Omega 3 Supplementation on the Metabolic and Inflammatory Markers of Cardiovascular Risk in Postmenopausal Women

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5668v4
Enrollment
Unknown
Registered
2013-10-04
Start date
2011-02-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome X, Potmenopause

Interventions

In this prospective and open study, 87 women with age above 45 years and last menstruation at least 12 months prior to this study, who were randomly assigned to two study arms. One group (control) of
Dietary supplement

Sponsors

Faculdade de Medicina de Botucatu da Universidade Estadual Paulista UNESP, Julio de Mesquita Filho
Lead Sponsor
FAPESP - Fundação de Amparo a Pesquisa do Estado de São Paulo
Collaborator

Eligibility

Sex/Gender
Female
Age
45 Years to 65 Years

Inclusion criteria

Inclusion criteria: Women with: (1) date of last menstrual period for at least 12 months, (2) age between 45 and 65 years, (3) at least three criteria for the diagnosis of metabolic syndrome (waist circumference > 88 cm; triglycerides > 150 mg/dL; HDL cholesterol 130/85 mmHg or under therapy; fasting glucose > 100 mg/dL or under therapy).

Exclusion criteria

Exclusion criteria: The exclusion criteria were: (1) presence of cardiovascular disease manifests current or previous, (2) use drugs that affect lipoprotein metabolism (hormone therapy, statins), (3) alcoholic or drogaditas; (4) story autoimmune diseases, (5) history of malignancy; (6) intolerance or food allergy to fish; (7) insulin-dependent diabetes.

Design outcomes

Primary

MeasureTime frame
It is expected that supplementation with omega-3 900mg/dia occurs reducing of triglycerides between 7-25% in postmenopausal women with metabolic syndrome compared women undergoing diet alone.;It is expected that supplementation with omega-3 supplementation 900mg/dia improves the inflammatory status, by cytokines values, in postmenopausal women with metabolic syndrome compared women undergoing diet alone.

Secondary

MeasureTime frame
It is expected that supplementation with omega-3 900mg/dia improves parameters of metabolic syndrome, such as improvement of insulin resistance (IR), assessed by HOMA-IR (Homeostasis Model Assessment-Insulin Resistant) calculated by the formula: Insulin (mU / mL) x fasting plasma glucose (mg / dl) / 405, with values?? > 3.6 indicate IR. Thus, the effect on blood pressure, reducing the values ??of systolic and diastolic blood pressure assessed by direct measurement of pressure.

Countries

Brazil

Contacts

Public ContactAna Paula Tardivo

Faculdade de Medicina de Botucatu da Universidade Estadual Paulista UNESP, Julio de Mesquita Filho

ana_tardivo@yahoo.com.br+55 (14) 38801377

Outcome results

None listed

Source: REBEC (via WHO ICTRP)