MenopauseNCT02816814
Lacto-ovo-vegetarian Diet Riched in Omega-3 Fatty Acids in Menopausal Women
A study testing Diet rich in omega-3 fatty acids and Diet with extra virgin olive oil in people with Menopause and Metabolic Syndrome, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 45 to 68 years, women only
- Conditions the study is for
- Menopause, Metabolic Syndrome, Hepatic Steatosis
- What is being tested?
- Diet rich in omega-3 fatty acids and Diet with extra virgin olive oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 68 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Castellana Grotte, Bari, 70013
About this study
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.
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.
Read more
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.
- Conditions
- Menopause, Metabolic Syndrome, Hepatic Steatosis
- Being tested
- Diet rich in omega-3 fatty acids, Diet with extra virgin olive oil
- Keywords
- Menopause, Diet, Lipidomic profile, Vasomotor symptoms, Omega-3 fatty acids
- Medical subject headings
- Metabolic Syndrome, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet rich in omega-3 fatty acidsOther
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 oilOther
A diet rich in EVO (25-30g/die) will be administered for 4 months to overwieght women in menopause
| Study group | Role | What they receive |
|---|---|---|
| Love Diet | Active comparator | Overweight females (BMI > 25) in menopause Receives: Other: Diet with extra virgin olive oil |
| LωVE diet | Experimental | Overweight females (BMI > 25) in menopause Receives: Other: Diet rich in omega-3 fatty acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months
Secondary outcomes (1)
Vasomotor menopausal symptoms by Kupermann scale
Vasomotor menopausal symptoms will be registered using a standardised questionnaire (Kupperman scale
Measured: Baseline, 1 month, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startNov 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Gabriella Caruso, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816814
- Sponsor's protocol ID
- RC242016
- Status last verified
- Jun 2016
- First submitted
- 17 Jun 2016
- Last updated
- 30 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02816814
- Acronym / sponsor ID
- RC242016
- Conditions
- Menopause, Metabolic Syndrome, Hepatic Steatosis
- Keywords
- Menopause, Diet, Lipidomic profile, Vasomotor symptoms, Omega-3 fatty acids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Love Diet | Active comparator | Other: Diet with extra virgin olive oilOverweight females (BMI > 25) in menopause |
| LωVE diet | Experimental | Other: Diet rich in omega-3 fatty acidsOverweight females (BMI > 25) in menopause |
Who may qualify
- Ages
- 45 to 68 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet rich in omega-3 fatty acidsA diet rich in omega-3 fatty acids (7g/die) will be administered for 4 months to overwieght women in menopause | Other | LωVE diet |
| Diet with extra virgin olive oilA diet rich in EVO (25-30g/die) will be administered for 4 months to overwieght women in menopause | Other | Love Diet |
Primary outcome
Fatty acids quantification by GC and expressed as ppm in erythrocyte membranes
Time frame: 4 months
Quantitative analysis of the fatty acids composition of erythrocyte membranes using gas cromatography
1 secondary outcome
Vasomotor menopausal symptoms by Kupermann scale
Time frame: Baseline, 1 month, 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet rich in omega-3 fatty acids and Diet with extra virgin olive oil in people with Menopause and Metabolic Syndrome, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatty acids quantification by GC and expressed as ppm in erythrocyte membranes (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2016.