Mediterranean DietNCT02840981
Adherence to the Mediterranean Diet and Circulating Levels of Sirtuin 4 in Obese Subjects
An observational study of Mediterranean Diet and Nutrition, run by Federico II University.
Trial summary
The Mediterranean diet (MD), a healthy dietary pattern based on some common dietary characteristics in Mediterranean countries, is associated with high antioxidant capacity linked to the low saturated fat intake that might contribute to reduce free fatty acid (FFA) availability and oxidation in mitochondria, thus… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Mediterranean Diet, Nutrition, Sirtuin 4
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Jan 2016
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 257 consecutive obese subjects visiting the out-patient Obesity Unit of the Section of Endocrinology, University of Naples Federico II
Who may be able to join
- Adult obese subjects
Who cannot join
- Hypocaloric diet in the last three months or specific nutritional regimens, including vegan or vegetarian diets;
- Presence of liver or renal failure, cancer, and acute or chronic inflammatory diseases based on a complete medical examination and laboratory investigations (psoriasis, rheumatoid arthritis and chronic obstructive pulmonary disease);
- Occasional or current of use of drugs affecting β-oxidation, including non-steroidal anti-inflammatory drugs, α-lipoic acid, valproic acid
- Use of weight loss medication or lipid-lowering drugs
- Altered thyroid hormone function tests or thyroid hormone treatment or altered somatotropic axis
- Alcohol abuse according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-V diagnostic criteria
- Vitamin/mineral or antioxidant supplementation
- Subjects dropped out from the study since they refused to undergo full laboratory-instrumental examinations.
About this study
Official title: Obese Patients Adhering to Mediterranean Diet Show Less Reduced Circulating Levels of Sirtuin 4
The Mediterranean diet (MD), a healthy dietary pattern based on some common dietary characteristics in Mediterranean countries, is associated with high antioxidant capacity linked to the low saturated fat intake that might contribute to reduce free fatty acid (FFA) availability and oxidation in mitochondria, thus reducing the production of the reactive oxygen species (ROS) superoxide, and promoting cellular health. To assess the adherence to the MD, a simple 14-item questionnaire had been tested in different settings by the PREDIMED (PREvención con DIeta MEDiterránea) multicenter, randomized, primary prevention trial. On the other hand, to allow a more an accurate measurement of the actual macro and micronutrient intakes, including dietary anti-oxidant micronutrients, the 7-day food records is considered as the "gold standard" of self-administered food frequency questionnaires.
Circulating levels of Sirtuin 4 (Sirt4), part of a complex of proteins that control diverse biological processes, including lipid metabolism, are low in obese patients, as a possible attempt to decrease fat oxidative capacity and mitochondrial ROS production, however promoting ectopic liver fat storage.
Read more
The phase angle (PA), a measure determined by bioelectrical impedance analysis (BIA), and the visceral adiposity index (VAI), a gender-specific mathematical index based on simple anthropometric and metabolic parameters, represent well-validated, reliable and widely used markers of cellular health and ectopic adipose distribution and function, respectively. The fatty liver index (FLI) is a surrogate measure for fatty liver recently proposed as an independent predictor for diabetes mellitus.
Aim of the present study was to investigate in adult obese individuals the levels of Sirt4 according to the adherence to the MD evaluated by PREDIMED questionnaire, focusing on the possible association with single dietary components evaluated by 7-day food records, and to evaluate the association between circulating levels of Sirt4 and PA, as marker of cellular health, VAI, as index of adipocyte dysfunction, and FLI, as a predictor of fatty liver.
- Conditions
- Mediterranean Diet, Nutrition, Sirtuin 4, Obesity
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Mediterranean Diet by Predimed Questionnaire
Measured: December 2013 to September 2015
Circulating Levels of Sirtuin 4 by ELISA method
Measured: December 2013 to September 2015
Obesity by Body Mass Index
Measured: December 2013 to September 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startDec 2013
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mediterranean DietStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Silvia Savastano, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840981
- Sponsor's protocol ID
- 5/14
- Status last verified
- Jul 2016
- First submitted
- 12 Jul 2016
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obese Patients Adhering to Mediterranean Diet Show Less Reduced Circulating Levels of Sirtuin 4
- ClinicalTrials.gov ID
- NCT02840981
- Acronym / sponsor ID
- 5/14
- Conditions
- Mediterranean Diet, Nutrition, Sirtuin 4, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 21 Jul 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.
The Mediterranean diet (MD), a healthy dietary pattern based on some common dietary characteristics in Mediterranean countries, is associated with high antioxidant capacity linked to the low saturated fat intake that might contribute to reduce free fatty acid (FFA) availability and oxidation in mitochondria, thus reducing the production of the reactive oxygen species (ROS) superoxide, and promoting cellular health. To assess the adherence to the MD, a simple 14-item questionnaire had been tested in different settings by the PREDIMED (PREvención con DIeta MEDiterránea) multicenter, randomized, primary prevention trial. On the other hand, to allow a more an accurate measurement of the actual macro and micronutrient intakes, including dietary anti-oxidant micronutrients, the 7-day food records is considered as the "gold standard" of self-administered food frequency questionnaires.
Circulating levels of Sirtuin 4 (Sirt4), part of a complex of proteins that control diverse biological processes, including lipid metabolism, are low in obese patients, as a possible attempt to decrease fat oxidative capacity and mitochondrial ROS production, however promoting ectopic liver fat storage.
The phase angle (PA), a measure determined by bioelectrical impedance analysis (BIA), and the visceral adiposity index (VAI), a gender-specific mathematical index based on simple anthropometric and metabolic parameters, represent well-validated, reliable and widely used markers of cellular health and ectopic adipose distribution and function, respectively. The fatty liver index (FLI) is a surrogate measure for fatty liver recently proposed as an independent predictor for diabetes mellitus.
Aim of the present study was to investigate in adult obese individuals the levels of Sirt4 according to the adherence to the MD evaluated by PREDIMED questionnaire, focusing on the possible association with single dietary components evaluated by 7-day food records, and to evaluate the association between circulating levels of Sirt4 and PA, as marker of cellular health, VAI, as index of adipocyte dysfunction, and FLI, as a predictor of fatty liver.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 257 consecutive obese subjects visiting the out-patient Obesity Unit of the Section of Endocrinology, University of Naples Federico II
Key inclusion criteria (1 listed)
- Adult obese subjects
Key exclusion criteria (8 listed)
- Hypocaloric diet in the last three months or specific nutritional regimens, including vegan or vegetarian diets;
- Presence of liver or renal failure, cancer, and acute or chronic inflammatory diseases based on a complete medical examination and laboratory investigations (psoriasis, rheumatoid arthritis and chronic obstructive pulmonary disease);
- Occasional or current of use of drugs affecting β-oxidation, including non-steroidal anti-inflammatory drugs, α-lipoic acid, valproic acid
- Use of weight loss medication or lipid-lowering drugs
- Altered thyroid hormone function tests or thyroid hormone treatment or altered somatotropic axis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adherence to Mediterranean Diet by Predimed Questionnaire
Time frame: December 2013 to September 2015
Circulating Levels of Sirtuin 4 by ELISA method
Time frame: December 2013 to September 2015
Obesity by Body Mass Index
Time frame: December 2013 to September 2015
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Mediterranean Diet and Nutrition, run by Federico II University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. 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: finished, as of the sponsor's last update on 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adherence to Mediterranean Diet by Predimed Questionnaire (time frame: December 2013 to September 2015). The study lists 3 primary outcomes in all. 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 21 Jul 2016.