Lacto-ovo-vegetarian Diet Riched in Omega-3 Fatty Acids in Menopausal Women

Metabolic Syndrome Clinical Trial

Official title:

Effects of a Lacto-ovo-vegetarian Diet Riched in Omega-3 Fatty Acids on the Lipidomic Membrane Profile of Erythrocyte in Menopausal Women.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02816814
• Other study ID #: RC242016
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 17, 2016
• Last updated: June 29, 2016
• Start date: November 2016
• Est. completion date: June 2018

Study information

• Verified date: June 2016
• Source: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Healthy lifestyle, based on healthy diet and exercise, is a key factor to prevent the most common menopausal disorders and chronic diseases to which women are more exposed during this life stage. Therefore, menopausal women may represent a target for evaluating the effectiveness of nutritional intervention studies based on protective diets against the common metabolic diseases, such as metabolic syndrome, obesity and hepatic steatosis.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 12
• Est. completion date: June 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 68 Years

Eligibility

Inclusion Criteria will be: post-menopausal female women with BMI 25-33; baseline fasting glucose<110 mg/dl; total cholesterol ranging from 200 mg/dl and 260 mg/dl; triglycerides ranging from150 mg/dl and 200 mg/dl.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Fatty Liver
• Hepatic Steatosis
• Menopause
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Other:
• 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

Locations

Country	Name	City	State
Italy	Azienda ospedaliera Specializzata in Gastroenterologia Saverio de Bellis	Castellana Grotte	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatty acids quantification by GC and expressed as ppm in erythrocyte membranes	Quantitative analysis of the fatty acids composition of erythrocyte membranes using gas cromatography	4 months	Yes
Secondary	Vasomotor menopausal symptoms by Kupermann scale	Vasomotor menopausal symptoms will be registered using a standardised questionnaire (Kupperman scale	Baseline, 1 month, 4 months	Yes