- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05244707
The Effects of a Mediterranean Style Diet in Heart Disease Patients Running a Cardiac Rehabilitation Program
February 7, 2022 updated by: Universidade Nova de Lisboa
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 Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
86
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eduarda Carreira
- Phone Number: +351 915 993 141
- Email: a2020511@nms.unl.pt
Study Contact Backup
- Name: Júlio C Rocha, PhD
- Phone Number: +351 218 841 000
- Email: rochajc@nms.unl.pt
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Subjects with heart failure (LVEF <50% or NT_proBNP> 125 ng / mL) on admission;
- Subjects with renal failure (GFR <50 or 60 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mediterranean style diet
Mediterranean style diet.
|
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.
|
Active Comparator: Standard of care
Standard of care.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported quality of life
Time Frame: baseline to 12 weeks
|
Difference between the intervention and control group in the EQ-5D-5L questionnaire from baseline to the end of follow-up.
|
baseline to 12 weeks
|
Adherence to the Mediterranean dietary pattern
Time Frame: baseline, 4 weeks, 8 weeks and 12 weeks
|
Difference between the intervention and control group in MEDAS questionnaire from baseline to 4 weeks, 8 weeks and 12 weeks.
|
baseline, 4 weeks, 8 weeks and 12 weeks
|
Change in weight
Time Frame: baseline to 12 weeks
|
Difference between the intervention and control group in the change of weight (kg) from baseline to 12 weeks.
|
baseline to 12 weeks
|
Change in body fat
Time Frame: baseline to 12 weeks
|
Difference between the intervention and control group in the change of body fat (%) from baseline to 12 weeks.
|
baseline to 12 weeks
|
Change in fat free mass
Time Frame: baseline to 12 weeks
|
Difference between the intervention and control group in the change of fat free mass (kg) from baseline to 12 weeks.
|
baseline to 12 weeks
|
Change in total body water
Time Frame: baseline to 12 weeks
|
Difference between the intervention and control group in the change of total body water (kg) from baseline to 12 weeks.
|
baseline to 12 weeks
|
Change in systolic blood pressure
Time Frame: baseline, 4 weeks, 8 weeks and 12 weeks
|
Difference between the intervention and control group in the change of systolic blood pressure from baseline to 4 weeks, 8 weeks and 12 weeks.
|
baseline, 4 weeks, 8 weeks and 12 weeks
|
Change in diastolic blood pressure
Time Frame: baseline, 4 weeks, 8 weeks and 12 weeks
|
Difference between the intervention and control group in the change of diastolic blood pressure from baseline to 4 weeks, 8 weeks and 12 weeks.
|
baseline, 4 weeks, 8 weeks and 12 weeks
|
Change of insulin
Time Frame: baseline, 4 weeks, 8 weeks and 12 weeks
|
Difference between the intervention and control group in the change of insulin from baseline to 4 weeks, 8 weeks and 12 weeks.
|
baseline, 4 weeks, 8 weeks and 12 weeks
|
Change of fasting blood glucose
Time Frame: baseline, 4 weeks, 8 weeks and 12 weeks
|
Difference between the intervention and control group in the change of fasting blood glucose from baseline to 4 weeks, 8 weeks and 12 weeks.
|
baseline, 4 weeks, 8 weeks and 12 weeks
|
Change of glycosylated hemoglobin (HbA1c)
Time Frame: baseline, 4 weeks, 8 weeks and 12 weeks
|
Difference between the intervention and control group in the change of glycosylated hemoglobin (HbA1c) from baseline to 4 weeks, 8 weeks and 12 weeks.
|
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
|
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.
|
baseline, 4 weeks, 8 weeks and 12 weeks
|
Change of LDL cholesterol
Time Frame: baseline, 4 weeks, 8 weeks and 12 weeks
|
Difference between the intervention and control group in the change of LDL- cholesterol from baseline to 4 weeks, 8 weeks and 12 weeks.
|
baseline, 4 weeks, 8 weeks and 12 weeks
|
Change of HDL cholesterol
Time Frame: baseline, 4 weeks, 8 weeks and 12 weeks
|
Difference between the intervention and control group in the change of HDL- cholesterol from baseline to 4 weeks, 8 weeks and 12 weeks.
|
baseline, 4 weeks, 8 weeks and 12 weeks
|
Change of triglycerides
Time Frame: baseline, 4 weeks, 8 weeks and 12 weeks
|
Difference between the intervention and control group in the change of triglycerides from baseline to 4 weeks, 8 weeks and 12 weeks.
|
baseline, 4 weeks, 8 weeks and 12 weeks
|
Change of apolipoprotein B
Time Frame: baseline, 4 weeks, 8 weeks and 12 weeks
|
Difference between the intervention and control group in the change of apolipoprotein B from baseline to 4 weeks, 8 weeks and 12 weeks.
|
baseline, 4 weeks, 8 weeks and 12 weeks
|
Change of apolipoprotein A1
Time Frame: baseline, 4 weeks, 8 weeks and 12 weeks
|
Difference between the intervention and control group in the change of apolipoprotein A1 from baseline to 4 weeks, 8 weeks and 12 weeks.
|
baseline, 4 weeks, 8 weeks and 12 weeks
|
Change of liporprotein(a)
Time Frame: baseline, 4 weeks, 8 weeks and 12 weeks
|
Difference between the intervention and control group in the change of liporprotein(a) from baseline to 4 weeks, 8 weeks and 12 weeks.
|
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
|
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.
|
baseline, 4 weeks, 8 weeks and 12 weeks
|
change of myeloperoxidase
Time Frame: baseline, 4 weeks, 8 weeks and 12 weeks
|
Difference between the intervention and control group in the change of myeloperoxidase from baseline to 4 weeks, 8 weeks and 12 weeks.
|
baseline, 4 weeks, 8 weeks and 12 weeks
|
Change of interleukin 1
Time Frame: baseline, 4 weeks, 8 weeks and 12 weeks
|
Difference between the intervention and control group in the change of interleukin 1 from baseline to 4 weeks, 8 weeks and 12 weeks.
|
baseline, 4 weeks, 8 weeks and 12 weeks
|
Change of interleukin 6
Time Frame: baseline, 4 weeks, 8 weeks and 12 weeks
|
Difference between the intervention and control group in the change of interleukin 6 from baseline to 4 weeks, 8 weeks and 12 weeks.
|
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
|
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.
|
baseline, 4 weeks, 8 weeks and 12 weeks
|
Change of trimethylamine N-oxide (TMAO)
Time Frame: baseline, 4 weeks, 8 weeks and 12 weeks
|
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.
|
baseline, 4 weeks, 8 weeks and 12 weeks
|
Change of L-carnitine
Time Frame: baseline, 4 weeks, 8 weeks and 12 weeks
|
Difference between the intervention and control group in the change of L-carnitine from baseline to 4 weeks, 8 weeks and 12 weeks.
|
baseline, 4 weeks, 8 weeks and 12 weeks
|
Change of urinary hydroxytyrosol
Time Frame: baseline, 4 weeks, 8 weeks and 12 weeks
|
Difference between the intervention and control group in the change of urinary hydroxytyrosol from baseline to 4 weeks, 8 weeks and 12 weeks.
|
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
|
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.
|
baseline, 4 weeks, 8 weeks and 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Pedro Rio, MD, Hospital de Santa Marta - Centro Hospitalar Universitário | Lisboa Central (CHULC)
- Study Director: André Moreira-Rosário, PhD, NOVA Medical School | Faculdade de Ciências Médicas da Universidade Nova de Lisboa
- Study Director: Júlio C Rocha, PhD, NOVA Medical School | Faculdade de Ciências Médicas da Universidade Nova de Lisboa
- Study Director: Diana Teixeira, PhD, NOVA Medical School | Faculdade de Ciências Médicas da Universidade Nova de Lisboa
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2022
Primary Completion (Anticipated)
July 1, 2022
Study Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
February 7, 2022
First Submitted That Met QC Criteria
February 7, 2022
First Posted (Actual)
February 17, 2022
Study Record Updates
Last Update Posted (Actual)
February 17, 2022
Last Update Submitted That Met QC Criteria
February 7, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NutriReHeart
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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