Metabolic SyndromeEtherpathsNCT01154478
Effects of Dietary Polyphenols and ω-3 Fatty Acids on Cardiovascular Risk Factors in High Risk Subjects
A study testing Diet rich in omega-3 fatty acids, Diet rich in polyphenols and diet rich in omega-3 and polyphenols in people with Metabolic Syndrome, run by Federico II University at 1 site in Italy.
Trial summary
The aim of this study is to explore if a 8-weeks dietary intervention with polyphenols and omega 3 fatty acids (alone or combined) may be effective on postprandial lipids metabolism and other cardiovascular risk factors in people at high cardiovascular risk. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Diet rich in omega-3 fatty acids, Diet rich in polyphenols and diet rich in omega-3 and polyphenols
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2010to Jun 2012
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- bmi >25<35 kg/m2
- High waist circumference (men >102 cm, women >88 cm) + one the following components of metabolic syndrome :
- Fasting plasma triglycerides ≥150 mg/dl Fasting HDL-col <40 mg/dl (men) and <50 mg/dl (women) Fasting plasma glucose 100-125 mg/dl
Who cannot join
- Fasting plasma triglycerides ≥400 mg/dl and cholesterol >270 mg/dl
- Cardiovascular events (AMI and/or stroke) in the last 6 months
- Diabetes mellitus
- Regular intensive physical activity
- Kidney (serum creatinine >1.7 mg/dl) and liver (transaminases >double)
- Hypolipidemic or antinflammatory drugs
- Anemia (Hb <12 g/dl) or any other chronic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Polyphenols and Omega-3 Fatty Acids on Cardiovascular Rik Factors (Focusing on Postprandial Lipids Metabolism) in Subjects With High Risk for Type 2 Diabetes and Cardiovascular Diseases
The aim of this study is to explore if a 8-weeks dietary intervention with polyphenols and omega 3 fatty acids (alone or combined) may be effective on postprandial lipids metabolism and other cardiovascular risk factors in people at high cardiovascular risk.
Read the detailed description
Fish consumption is associated with a lower cardiovascular risk and dietary supplementation with ω-3 fatty acids reduces plasma triglyceride levels. The mechanisms of action of ω-3 fatty acids are currently not completely understood. It has been hypothesized that polyunsaturated ω-3 fatty acids beneficial effects may be mediated through their ability to facilitate plasmalogen replenishment.
Polyphenols are associated with beneficial effects on some cardiovascular risk factors, in particular with a reduced lipid oxidation. Less data are available on their effects on lipid metabolism. Recent data suggest that these effects could be mediated by changes in plasmalogen levels.
The effects on lipid metabolism of combining the two dietary approaches (ω-3 fatty acids and polyphenols) are not known.
While developed populations live for the most part in the postprandial state, much of the information on lipid metabolism refers to fasting condition.
Dietary Intervention Study Design
Eighty people at high cardiovascular risk randomly assigned to one of the four different nutritional 8-week interventions:
(A) Control diet poor in omega-3 fatty acids and polyphenols (B) Diet rich in omega-3 fatty acids (C) Diet rich in polyphenols (D) Diet rich in omega-3 fatty acids and polyphenols
- Conditions
- Metabolic Syndrome
- Being tested
- Diet rich in omega-3 fatty acids, Diet rich in polyphenols, Control diet, diet rich in omega-3 and polyphenols
- Keywords
- polyphenols omega-3 postprandial lipemia adipose tissue
- Medical subject headings
- Metabolic Syndrome
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
fish at least 3 times per week, large leaf vegetables
Diet rich in polyphenolsOther
extra virgin olive oil, green tea, berries,fruits rich in polyphenols, dark chocolate, decaffenated coffee
Control dietOther
low content of omega-3 fatty acids and polyphenols (low intake of fish, nuts and legumes,oil rich in monounsaturated fatty acids, vegetables and fruits poor in polyphenols)
diet rich in omega-3 and polyphenolsOther
Fish at least 3 times x week,large leaf vegetables + extra virgin olive oil, green tea, berries,fruits rich in polyphenols, dark chocolate, decaffenated coffee
| Study group | Role | What they receive |
|---|---|---|
| B group | Experimental | Diet rich in omega-3 fatty acids Receives: Other: Diet rich in omega-3 fatty acids |
| C group | Experimental | Diet rich in polyphenols Receives: Other: Diet rich in polyphenols |
| D group | Experimental | Diet rich in polyphenols and in omega-3 fatty acids Receives: Other: diet rich in omega-3 and polyphenols |
| A group (control group) | Placebo comparator | diet with low content of omega-3 fatty acids and polyphenols Receives: Other: Control diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
incremental AUC after a test meal of triglycerides concentration in chylomicrons and VLDL fraction
Measured: 48 months
Secondary outcomes (3)
insulin sensitivity
Measured: 48 months
plasma and adipose tissue adipokines
Measured: 48 months
endothelial function
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rivellese angela, Federico II University
- Investigators
- Giovanni Annuzzi, Study director, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154478
- Sponsor's protocol ID
- EpWP5
- Acronym
- Etherpaths
- Status last verified
- Jun 2013
- First submitted
- 14 Jun 2010
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Costabile G, Vetrani C, Bozzetto L, Giacco R, Bresciani L, Del Rio D, Vitale M, Della Pepa G, Brighenti F, Riccardi G, Rivellese AA, Annuzzi G. Plasma TMAO increase after healthy diets: results from 2 randomized controlled trials with dietary fish, polyphenols, and whole-grain cereals. Am J Clin Nutr. 2021 Oct 4;114(4):1342-1350. doi: 10.1093/ajcn/nqab188.
PubMed 34091663Della Pepa G, Vetrani C, Vitale M, Bozzetto L, Costabile G, Cipriano P, Mangione A, Patti L, Riccardi G, Rivellese AA, Annuzzi G. Effects of a diet naturally rich in polyphenols on lipid composition of postprandial lipoproteins in high cardiometabolic risk individuals: an ancillary analysis of a randomized controlled trial. Eur J Clin Nutr. 2020 Jan;74(1):183-192. doi: 10.1038/s41430-019-0459-0. Epub 2019 Jun 27.
PubMed 31249395Bozzetto L, Annuzzi G, Ragucci M, Di Donato O, Della Pepa G, Della Corte G, Griffo E, Anniballi G, Giacco A, Mancini M, Rivellese AA. Insulin resistance, postprandial GLP-1 and adaptive immunity are the main predictors of NAFLD in a homogeneous population at high cardiovascular risk. Nutr Metab Cardiovasc Dis. 2016 Jul;26(7):623-629. doi: 10.1016/j.numecd.2016.01.011. Epub 2016 Apr 14.
PubMed 27134062Bozzetto L, Annuzzi G, Pacini G, Costabile G, Vetrani C, Vitale M, Griffo E, Giacco A, De Natale C, Cocozza S, Della Pepa G, Tura A, Riccardi G, Rivellese AA. Polyphenol-rich diets improve glucose metabolism in people at high cardiometabolic risk: a controlled randomised intervention trial. Diabetologia. 2015 Jul;58(7):1551-60. doi: 10.1007/s00125-015-3592-x. Epub 2015 Apr 24.
PubMed 25906754
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Polyphenols and Omega-3 Fatty Acids on Cardiovascular Rik Factors (Focusing on Postprandial Lipids Metabolism) in Subjects With High Risk for Type 2 Diabetes and Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT01154478
- Acronym / sponsor ID
- Etherpaths / EpWP5
- Conditions
- Metabolic Syndrome
- Keywords
- polyphenols omega-3 postprandial lipemia adipose tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 1 Jul 2010 (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 aim of this study is to explore if a 8-weeks dietary intervention with polyphenols and omega 3 fatty acids (alone or combined) may be effective on postprandial lipids metabolism and other cardiovascular risk factors in people at high cardiovascular risk.
Detailed description
Fish consumption is associated with a lower cardiovascular risk and dietary supplementation with ω-3 fatty acids reduces plasma triglyceride levels. The mechanisms of action of ω-3 fatty acids are currently not completely understood. It has been hypothesized that polyunsaturated ω-3 fatty acids beneficial effects may be mediated through their ability to facilitate plasmalogen replenishment.
Polyphenols are associated with beneficial effects on some cardiovascular risk factors, in particular with a reduced lipid oxidation. Less data are available on their effects on lipid metabolism. Recent data suggest that these effects could be mediated by changes in plasmalogen levels.
The effects on lipid metabolism of combining the two dietary approaches (ω-3 fatty acids and polyphenols) are not known.
While developed populations live for the most part in the postprandial state, much of the information on lipid metabolism refers to fasting condition.
Dietary Intervention Study Design
Eighty people at high cardiovascular risk randomly assigned to one of the four different nutritional 8-week interventions:
(A) Control diet poor in omega-3 fatty acids and polyphenols (B) Diet rich in omega-3 fatty acids (C) Diet rich in polyphenols (D) Diet rich in omega-3 fatty acids and polyphenols
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| B group | Experimental | Other: Diet rich in omega-3 fatty acidsDiet rich in omega-3 fatty acids |
| C group | Experimental | Other: Diet rich in polyphenolsDiet rich in polyphenols |
| D group | Experimental | Other: diet rich in omega-3 and polyphenolsDiet rich in polyphenols and in omega-3 fatty acids |
| A group (control group) | Placebo comparator | Other: Control dietdiet with low content of omega-3 fatty acids and polyphenols |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- bmi >25<35 kg/m2
- High waist circumference (men >102 cm, women >88 cm) + one the following components of metabolic syndrome :
- Fasting plasma triglycerides ≥150 mg/dl Fasting HDL-col <40 mg/dl (men) and <50 mg/dl (women) Fasting plasma glucose 100-125 mg/dl
Key exclusion criteria (7 listed)
- Fasting plasma triglycerides ≥400 mg/dl and cholesterol >270 mg/dl
- Cardiovascular events (AMI and/or stroke) in the last 6 months
- Diabetes mellitus
- Regular intensive physical activity
- Kidney (serum creatinine >1.7 mg/dl) and liver (transaminases >double)
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 acidsfish at least 3 times per week, large leaf vegetables | Other | B group |
| Diet rich in polyphenolsextra virgin olive oil, green tea, berries,fruits rich in polyphenols, dark chocolate, decaffenated coffee | Other | C group |
| Control dietlow content of omega-3 fatty acids and polyphenols (low intake of fish, nuts and legumes,oil rich in monounsaturated fatty acids, vegetables and fruits poor in polyphenols) | Other | A group (control group) |
| diet rich in omega-3 and polyphenolsFish at least 3 times x week,large leaf vegetables + extra virgin olive oil, green tea, berries,fruits rich in polyphenols, dark chocolate, decaffenated coffee | Other | D group |
Primary outcome
incremental AUC after a test meal of triglycerides concentration in chylomicrons and VLDL fraction
Time frame: 48 months
3 secondary outcomes
insulin sensitivity
Time frame: 48 months
plasma and adipose tissue adipokines
Time frame: 48 months
endothelial function
Time frame: 48 months
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 19 Jun 2013.
- Derived from this study: PubMed 34091663Costabile G, Vetrani C, Bozzetto L, Giacco R, Bresciani L, Del Rio D, Vitale M, Della Pepa G, Brighenti F, Riccardi G, Rivellese AA, Annuzzi G. Plasma TMAO increase after healthy diets: results from 2 randomized controlled trials with dietary fish, polyphenols, and whole-grain cereals. Am J Clin Nutr. 2021 Oct 4;114(4):1342-1350. doi: 10.1093/ajcn/nqab188.
- Derived from this study: PubMed 31249395Della Pepa G, Vetrani C, Vitale M, Bozzetto L, Costabile G, Cipriano P, Mangione A, Patti L, Riccardi G, Rivellese AA, Annuzzi G. Effects of a diet naturally rich in polyphenols on lipid composition of postprandial lipoproteins in high cardiometabolic risk individuals: an ancillary analysis of a randomized controlled trial. Eur J Clin Nutr. 2020 Jan;74(1):183-192. doi: 10.1038/s41430-019-0459-0. Epub 2019 Jun 27.
- Derived from this study: PubMed 27134062Bozzetto L, Annuzzi G, Ragucci M, Di Donato O, Della Pepa G, Della Corte G, Griffo E, Anniballi G, Giacco A, Mancini M, Rivellese AA. Insulin resistance, postprandial GLP-1 and adaptive immunity are the main predictors of NAFLD in a homogeneous population at high cardiovascular risk. Nutr Metab Cardiovasc Dis. 2016 Jul;26(7):623-629. doi: 10.1016/j.numecd.2016.01.011. Epub 2016 Apr 14.
- Derived from this study: PubMed 25906754Bozzetto L, Annuzzi G, Pacini G, Costabile G, Vetrani C, Vitale M, Griffo E, Giacco A, De Natale C, Cocozza S, Della Pepa G, Tura A, Riccardi G, Rivellese AA. Polyphenol-rich diets improve glucose metabolism in people at high cardiometabolic risk: a controlled randomised intervention trial. Diabetologia. 2015 Jul;58(7):1551-60. doi: 10.1007/s00125-015-3592-x. Epub 2015 Apr 24.
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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.
Giovanni Annuzzi study director
Federico II University
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, Diet rich in polyphenols and diet rich in omega-3 and polyphenols in people with Metabolic Syndrome, run by Federico II University 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?
The sponsor lists 3 inclusion and 7 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 19 Jun 2013. 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. Some participants in this study may receive a placebo. 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?
incremental AUC after a test meal of triglycerides concentration in chylomicrons and VLDL fraction (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01154478, which also lists 4 linked publications.
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 19 Jun 2013.