The aim of this study is to investigate the effect of a dietary intervention geared towards improved adherence to the Dutch dietary guidelines on the 10-year risk for recurrent vascular events (SMART risk score) in patients with cardiovascular…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The change in Smart Risk Score from baseline until 6 months will be the primary
outcome of this study. The SMART Risk Score estimates the 10-year risk for
recurrent vascular events in patients with manifest cardiovascular disease
based on the following modifiable parameters: systolic blood pressure,
creatinine, hsCRP and cholesterol.
Secondary outcome
Secondary study variables are the difference in biomedical cardiovascular
outcomes, nutritional status, and mental and physical wellbeing between
intervention and control group from baseline to 6 months.
Cardiovascular outcomes include systolic and diastolic blood pressure,
biomarkers such as hba1c, cholesterol, triglycerides, eGFR, insulin and glucose
and inflammation markers. In addition, we measure urine to be able to determine
salt and protein. Body weight and waist circumference are further outcomes of
the study.
Nutritional status is measured by the DHD15 index, which requires participants
to complete a habitual diet questionnaire. Furthermore, a number of biomarkers
for nutrition are used.
Mental and physical fitness is measured with questionnaires about quality of
life, self-efficacy, mental status, and physical activity. In addition, data on
health care use is requested and hospitalization, development of comorbidities
and mortality from the patient files will be assessed.
Background summary
In contrast with the wealth of data on the role of nutrition in prevention of
disease, there is a sparsity of data on the effect of better adherence to
dietary guidelines on secondary prevention of disease in patients with
cardiovascular diseases.
Study objective
The aim of this study is to investigate the effect of a dietary intervention
geared towards improved adherence to the Dutch dietary guidelines on the
10-year risk for recurrent vascular events (SMART risk score) in patients with
cardiovascular diseases compared with usual care.
Study design
The study will be a 6-months randomized, controlled trial. Hereafter,
participants will be followed-up for 6 months.
Intervention
The intervention group will receive personalized guidance from a dietician to
improve adherence to the Dutch dietary guidelines, the control group will
receive usual care.
Study burden and risks
Participants of the study will be asked to complete questionnaires, donate
blood samples and collect 24hr urine samples. Participants in the intervention
group will meet with a dietitian at least seven times, and will be stimulated
to adjust their dietary intake towards better adherence with the dietary
guidelines. The dietary advices that are given in this study are the Dutch
Dietary Guidelines (Richtlijnen Goede Voeding), which means these advices are
applicable to the whole Dutch society. These guidelines are based on years of
scientific evidence and are generally regarded as safe advices, without direct
risks for patients. Benefits for participants include probable improvements of
cardiovascular risk factors which can lead to reduction of symptoms and
improvement of quality of life. This research may be beneficial to group of
cardiovascular patients, since the results will probably contribute to a
dietary guideline for their disease.
Stippeneng 4
Wageningen 6708 WE
NL
Stippeneng 4
Wageningen 6708 WE
NL
Listed location countries
Age
Inclusion criteria
- Be categorised in the highest risk category of the guideline for
cardiovascular risk management 2019 (Tjin-A-Ton, J., & Vrolijk, M., 2019). This
includes patients with:
o Previously diagnosed cardiovascular disease, including acute coronary disease
syndrome, angina, coronary revascularization, TIA or stroke, symptomatic aortic
iliofemoral atherosclerosis, aortic aneurysm, intermittent claudication or
peripheral revascularization.
- Aged 18 year or older.
Exclusion criteria
- Uses medication (e.g. metformine, sulfonylureumderivate, insulin or
DPP4-inhibitors/GLP1-agonists) for treatment of diabetes
- a known hereditary form of cardiovascular diseases (e.g. Familial
hypercholesterolaemia)
- chronic kidney disease in stage 4 or above (meaning an eGFR<30)
o In this case, patients should get dietary advise about their protein intake,
which is not in line with the general advise in our study
- The patient has changes in one or more of the following medication in the
past two weeks: lipid-lowering agents, blood pressure-lowering agents,
glucose-lowering agents and antithrombotics
- The patient participates in another research study of which the outcomes may
interfere with the current trial
- Not able to speak and understand the Dutch language
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73021.091.20 |