Lacto-ovo-vegetarian Diet Riched in Omega-3 Fatty Acids in Menopausal Women
NCT ID: NCT02816814
Last Updated: 2016-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
12 participants
INTERVENTIONAL
2016-11-30
2018-06-30
Brief Summary
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Lipidomics aims to study the lipid molecules in a "dynamic" way and allows to define not only structure and functions of a set of lipid species present in an organism, but also the changes that occur during cell metabolism under physiological and pathological conditions in order to understand their role as part of the complex functional balance of a living organism.
Quantitative and qualitative determination of fatty acids profiles in cell membranes allows to follow their molecular changes occurring for intrinsic and extrinsic metabolic causes, such as inflammation, stress, nutrition.
Scientific evidence has shown that, for nutritional studies, the most representative cell is the erythrocyte, which is a biomarker of an individual's general state of health. In fact, the evaluation of the fatty acid composition contained in the membrane of red blood cell, which has an half-life of four months, allows to follow the nutritional status of a subject and to acquire information about his eating habits, with special reference to fat consumption.
The higher intake of omega-3 fatty acids is associated with a decreased inflammatory state which is often altered in patients with metabolic diseases, hepatic steatosis and obesity.
Overweight or obese women in menopause for at least 12 months, aged between 45 and 68 years, will be submitted at baseline to blood samples for lipidomic profile, blood tests, medical examination with blood pressure and anthropometric measurements (weight, height, waist and hip circumferences), indirect calorimetry and bioimpedentiometry. Participants will be randomly assigned to diet with extra virgin olive oil (LoVE DIET) or to diet riched in omega-3 fatty acids (LωVE DIET) for four months. During the treatment period, women enrolled will undergo medical examination and dietary control to assess the adherence to the dietary pattern, collecting anthropometric measurements, indirect calorimetry and bioimpedentiometry after 4 and 16 weeks as well as blood samples after 16 weeks.
The results will be analyzed using appropriate statistical tests. All patients will be made to sign an informed consent.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Love Diet
Overweight females (BMI \> 25) in menopause
Diet with extra virgin olive oil
A diet rich in EVO (25-30g/die) will be administered for 4 months to overwieght women in menopause
LωVE diet
Overweight females (BMI \> 25) in menopause
Diet rich in omega-3 fatty acids
A diet rich in omega-3 fatty acids (7g/die) will be administered for 4 months to overwieght women in menopause
Interventions
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Diet rich in omega-3 fatty acids
A diet rich in omega-3 fatty acids (7g/die) will be administered for 4 months to overwieght women in menopause
Diet with extra virgin olive oil
A diet rich in EVO (25-30g/die) will be administered for 4 months to overwieght women in menopause
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria will be: hormone replacement therapy, lipid-lowering therapy, use of corticosteroids and/or nutraceutics in the previous six months, patients with a history of cancer or in chemotherapy.
45 Years
68 Years
FEMALE
No
Sponsors
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Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
OTHER
Responsible Party
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Maria Gabriella Caruso
MD
Locations
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Azienda ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Castellana Grotte, Bari, Italy
Countries
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Other Identifiers
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RC242016
Identifier Type: -
Identifier Source: org_study_id