Acute Myocardial Infarction With ST ElevationNCT05244707
The Effects of a Mediterranean Style Diet in Heart Disease Patients Running a Cardiac Rehabilitation Program
A study testing Mediterranean style diet in people with Acute Myocardial Infarction With ST Elevation, run by Universidade Nova de Lisboa at 1 site in Portugal.
Trial summary
Nutrition is capable of altering the cardiovascular health of the general population. However, the ideal food and nutritional interventions for the secondary prevention of cardiovascular brain disease and for cardiac rehabilitation are still far from being defined, given the lack of scientific evidence in this… Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Acute Myocardial Infarction With ST Elevation
- What is being tested?
- Mediterranean style diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jun 2022to 31 Dec 2022
- 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women with ST-segment elevation acute myocardial infarction undergoing primary angioplasty;
- Ages 30-90 years;
- Willing and able to provide written informed consent.
Who cannot join
- Subjects with heart failure (LVEF <40%) on admission;
- Subjects with renal failure (GFR <50 ml / min / 1.73m²);
- Subjects requiring internment;
- Subjects who present any other condition that may interfere with adherence to the study protocol.
- Subjects who attract to be accompanied by another nutritionist;
- Subjects who have a specific dietary pattern or who take vitamin and/or mineral supplements;
- Subjects unable to give consent.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
NOVA Medical School | Universidade NOVA de Lisboa Campo Mártires da Pátria, 130
Lisbon, 1169-056 Lisboa
About this study
Nutrition is capable of altering the cardiovascular health of the general population. However, the ideal food and nutritional interventions for the secondary prevention of cardiovascular brain disease and for cardiac rehabilitation are still far from being defined, given the lack of scientific evidence in this specific population of individuals with atherosclerotic disease. This work aims to demonstrate that an intensive program will improve cardiovascular risk predictor parameters, such as high systolic blood pressure, altered lipid and glucose profile, used in the SMART Risk Score tool. In this 12-week clinical study with two arms running in parallel, individuals referred to a cardiac rehabilitation program will receive either an intensive food and nutrition intervention program with nutrition consultations, in which the adoption of the Mediterranean diet is promoted, with contacts telephone calls, short text messages, consultation support tools, podcasts, free access short videos, culinary medicine sessions and nutrition "workshops", or the standard of care program recommended in the Nutritional Support Protocol of the Cardiac Rehabilitation Program. At the beginning of the study, at 4 weeks, at 8 weeks and at 12 weeks, blood and urine samples will be collected, body composition, blood pressure, adherence to the Mediterranean dietary pattern will be assessed, by applying the PREDIMED questionnaire and the dietary intake of 24h previous. The quality of life of individuals will be assessed by the EQ-5D-5L questionnaire at the beginning and at the end of the study. It is expected that the increased intensity and support from the intensive program will have a significant impact on the various metabolic and inflammatory markers predictive of cardiovascular risk and that these observed changes will result in a decreased 10-year risk of developing acute myocardial infarction, stroke or vascular death. On the other hand, the intervention is intended to improve quality of life, improve weight control and assess the impact it has on adherence to the Mediterranean dietary pattern.
- Being tested
- Mediterranean style diet, Standard of care
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean style dietBehavioural
The intervention will consist of an intensive food and nutrition intervention program to improve adherence to the Mediterranean dietary pattern. In addition to individual and face-to-face nutrition consultations, other strategies will be used, such as telephone contacts, short text messages, consultation support tools, podcasts, short open access videos, nutrition workshops and nutrition sessions for caregivers of participants in the study.
Standard of careBehavioural
The usual care group will only have access to face-to-face and individual nutrition consultations in order to improve adherence to the Mediterranean dietary pattern.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean style diet | Experimental | Mediterranean style diet. Receives: Behavioral: Mediterranean style diet |
| Standard of care | Active comparator | Standard of care. Receives: Behavioral: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SMART Risk Score
Difference between the intervention and control group in the change in SMART Risk Score from baseline to the end of follow-up.
Measured: baseline to 12 weeks
Secondary outcomes (27)
Self-reported quality of life
Difference between the intervention and control group in the EQ-5D-5L questionnaire from baseline to the end of follow-up.
Measured: baseline to 12 weeks
Adherence to the Mediterranean dietary pattern
Difference between the intervention and control group in MEDAS questionnaire from baseline to 4 weeks, 8 weeks and 12 weeks.
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
Change in weight
Difference between the intervention and control group in the change of weight (kg) from baseline to 12 weeks.
Measured: baseline to 12 weeks
Change in body fat
Difference between the intervention and control group in the change of body fat (%) from baseline to 12 weeks.
Measured: baseline to 12 weeks
Change in fat free mass
Difference between the intervention and control group in the change of fat free mass (kg) from baseline to 12 weeks.
Measured: baseline to 12 weeks
Change in total body water
Difference between the intervention and control group in the change of total body water (kg) from baseline to 12 weeks.
Measured: baseline to 12 weeks
Change in systolic blood pressure
Difference between the intervention and control group in the change of systolic blood pressure from baseline to 4 weeks, 8 weeks and 12 weeks.
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
Change in diastolic blood pressure
Difference between the intervention and control group in the change of diastolic blood pressure from baseline to 4 weeks, 8 weeks and 12 weeks.
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
Change of insulin
Difference between the intervention and control group in the change of insulin from baseline to 4 weeks, 8 weeks and 12 weeks.
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
Change of fasting blood glucose
Difference between the intervention and control group in the change of fasting blood glucose from baseline to 4 weeks, 8 weeks and 12 weeks.
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
Change of glycosylated hemoglobin (HbA1c)
Difference between the intervention and control group in the change of glycosylated hemoglobin (HbA1c) from baseline to 4 weeks, 8 weeks and 12 weeks.
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
Change of type 1 insulin-like growth factor (IGF-1)
Difference between the intervention and control group in the change of type 1 insulin-like growth factor (IGF-1) from baseline to 4 weeks, 8 weeks and 12 weeks.
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
Change of LDL cholesterol
Difference between the intervention and control group in the change of LDL- cholesterol from baseline to 4 weeks, 8 weeks and 12 weeks.
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
Change of HDL cholesterol
Difference between the intervention and control group in the change of HDL- cholesterol from baseline to 4 weeks, 8 weeks and 12 weeks.
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
Change of triglycerides
Difference between the intervention and control group in the change of triglycerides from baseline to 4 weeks, 8 weeks and 12 weeks.
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
Change of apolipoprotein B
Difference between the intervention and control group in the change of apolipoprotein B from baseline to 4 weeks, 8 weeks and 12 weeks.
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
Change of apolipoprotein A1
Difference between the intervention and control group in the change of apolipoprotein A1 from baseline to 4 weeks, 8 weeks and 12 weeks.
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
Change of liporprotein(a)
Difference between the intervention and control group in the change of liporprotein(a) from baseline to 4 weeks, 8 weeks and 12 weeks.
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
Change of high sensitivity C-reactive protein
Difference between the intervention and control group in the change of high sensitivity C-reactive protein from baseline to 4 weeks, 8 weeks and 12 weeks.
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
change of myeloperoxidase
Difference between the intervention and control group in the change of myeloperoxidase from baseline to 4 weeks, 8 weeks and 12 weeks.
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
Change of interleukin 1
Difference between the intervention and control group in the change of interleukin 1 from baseline to 4 weeks, 8 weeks and 12 weeks.
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
Change of interleukin 6
Difference between the intervention and control group in the change of interleukin 6 from baseline to 4 weeks, 8 weeks and 12 weeks.
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
Change of tumor necrosis factor alpha (TNF-α)
Difference between the intervention and control group in the change of tumor necrosis factor alpha (TNF-α) from baseline to 4 weeks, 8 weeks and 12 weeks.
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
Change of trimethylamine N-oxide (TMAO)
Difference between the intervention and control group in the change of trimethylamine N-oxide (TMAO) from baseline to 4 weeks, 8 weeks and 12 weeks.
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
Change of L-carnitine
Difference between the intervention and control group in the change of L-carnitine from baseline to 4 weeks, 8 weeks and 12 weeks.
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
Change of urinary hydroxytyrosol
Difference between the intervention and control group in the change of urinary hydroxytyrosol from baseline to 4 weeks, 8 weeks and 12 weeks.
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
Change of plasma proportion of alpha linolenic acid
Difference between the intervention and control group in the change of plasma proportion of alpha linolenic acid from baseline to 4 weeks, 8 weeks and 12 weeks.
Measured: baseline, 4 weeks, 8 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start1 Jun 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial Infarction With ST ElevationStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Nova de Lisboa
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Hospitalar de Lisboa Central
- Responsible party
- Sponsor
- Investigators
- Pedro Rio, MD, Principal investigator, Hospital de Santa Marta - Centro Hospitalar Universitário | Lisboa Central (CHULC)Conceição Calhau, PhD, Principal investigator, NOVA Medical School | Faculdade de Ciências Médicas da Universidade NOVA de LisboaAndré Moreira-Rosário, PhD, Study director, NOVA Medical School | Faculdade de Ciências Médicas da Universidade NOVA de LisboaJúlio C Rocha, PhD, Study director, NOVA Medical School | Faculdade de Ciências Médicas da Universidade NOVA de LisboaDiana Teixeira, PhD, Study director, NOVA Medical School | Faculdade de Ciências Médicas da Universidade NOVA de Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244707
- Sponsor's protocol ID
- NutriReHeart
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2022
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) from this study will not be publicly shared because the ethics committee has limited their use to the approved research project. However, anonymised partial data sets or summary data may be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Mediterranean Style Diet in Heart Disease Patients Running a Cardiac Rehabilitation Program
- ClinicalTrials.gov ID
- NCT05244707
- Acronym / sponsor ID
- NutriReHeart
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Universidade Nova de LisboaUniversity, hospital or other
- Collaborators
- Centro Hospitalar de Lisboa Central
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 17 Feb 2022 (actual)
- 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.
Nutrition is capable of altering the cardiovascular health of the general population. However, the ideal food and nutritional interventions for the secondary prevention of cardiovascular brain disease and for cardiac rehabilitation are still far from being defined, given the lack of scientific evidence in this specific population of individuals with atherosclerotic disease. This work aims to demonstrate that an intensive program will improve cardiovascular risk predictor parameters, such as high systolic blood pressure, altered lipid and glucose profile, used in the SMART Risk Score tool. In this 12-week clinical study with two arms running in parallel, individuals referred to a cardiac rehabilitation program will receive either an intensive food and nutrition intervention program with nutrition consultations, in which the adoption of the Mediterranean diet is promoted, with contacts telephone calls, short text messages, consultation support tools, podcasts, free access short videos, culinary medicine sessions and nutrition "workshops", or the standard of care program recommended in the Nutritional Support Protocol of the Cardiac Rehabilitation Program. At the beginning of the study, at 4 weeks, at 8 weeks and at 12 weeks, blood and urine samples will be collected, body composition, blood pressure, adherence to the Mediterranean dietary pattern will be assessed, by applying the PREDIMED questionnaire and the dietary intake of 24h previous. The quality of life of individuals will be assessed by the EQ-5D-5L questionnaire at the beginning and at the end of the study. It is expected that the increased intensity and support from the intensive program will have a significant impact on the various metabolic and inflammatory markers predictive of cardiovascular risk and that these observed changes will result in a decreased 10-year risk of developing acute myocardial infarction, stroke or vascular death. On the other hand, the intervention is intended to improve quality of life, improve weight control and assess the impact it has on adherence to the Mediterranean dietary pattern.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterranean style diet | Experimental | Behavioral: Mediterranean style dietMediterranean style diet. |
| Standard of care | Active comparator | Behavioral: Standard of careStandard of care. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women with ST-segment elevation acute myocardial infarction undergoing primary angioplasty;
- Ages 30-90 years;
- Willing and able to provide written informed consent.
Key exclusion criteria (7 listed)
- Subjects with heart failure (LVEF <40%) on admission;
- Subjects with renal failure (GFR <50 ml / min / 1.73m²);
- Subjects requiring internment;
- Subjects who present any other condition that may interfere with adherence to the study protocol.
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 |
|---|---|---|
| Mediterranean style dietThe intervention will consist of an intensive food and nutrition intervention program to improve adherence to the Mediterranean dietary pattern. In addition to individual and face-to-face nutrition consultations, other strategies will be used, such as telephone contacts, short text messages, consultation support tools, podcasts, short open access videos, nutrition workshops and nutrition sessions for caregivers of participants in the study. | Behavioural | Mediterranean style diet |
| Standard of careThe usual care group will only have access to face-to-face and individual nutrition consultations in order to improve adherence to the Mediterranean dietary pattern. | Behavioural | Standard of care |
Primary outcome
Change in SMART Risk Score
Time frame: baseline to 12 weeks
Difference between the intervention and control group in the change in SMART Risk Score from baseline to the end of follow-up.
27 secondary outcomes
Self-reported quality of life
Time frame: baseline to 12 weeks
Adherence to the Mediterranean dietary pattern
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Change in weight
Time frame: baseline to 12 weeks
Change in body fat
Time frame: baseline to 12 weeks
Change in fat free mass
Time frame: baseline to 12 weeks
Change in total body water
Time frame: baseline to 12 weeks
Change in systolic blood pressure
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Change in diastolic blood pressure
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Change of insulin
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Change of fasting blood glucose
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Change of glycosylated hemoglobin (HbA1c)
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Change of type 1 insulin-like growth factor (IGF-1)
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Change of LDL cholesterol
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Change of HDL cholesterol
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Change of triglycerides
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Change of apolipoprotein B
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Change of apolipoprotein A1
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Change of liporprotein(a)
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Change of high sensitivity C-reactive protein
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
change of myeloperoxidase
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Change of interleukin 1
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Change of interleukin 6
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Change of tumor necrosis factor alpha (TNF-α)
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Change of trimethylamine N-oxide (TMAO)
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Change of L-carnitine
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Change of urinary hydroxytyrosol
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
Change of plasma proportion of alpha linolenic acid
Time frame: baseline, 4 weeks, 8 weeks and 12 weeks
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 17 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) from this study will not be publicly shared because the ethics committee has limited their use to the approved research project. However, anonymised partial data sets or summary data may be made available upon reasonable request.
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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.
Pedro Rio, MD principal investigator
Hospital de Santa Marta - Centro Hospitalar Universitário | Lisboa Central (CHULC)
Conceição Calhau, PhD principal investigator
NOVA Medical School | Faculdade de Ciências Médicas da Universidade NOVA de Lisboa
André Moreira-Rosário, PhD study director
NOVA Medical School | Faculdade de Ciências Médicas da Universidade NOVA de Lisboa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean style diet in people with Acute Myocardial Infarction With ST Elevation, run by Universidade Nova de Lisboa at 1 site in Portugal.
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 17 Feb 2026. 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 Portugal. 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?
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?
Change in SMART Risk Score (time frame: baseline to 12 weeks). 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 17 Feb 2026.