Acute Coronary SyndromeNCT06485765
DASH Diet, Quality of Life and Cardiac Parameters of Patients With Acute Coronary Syndrome
A study testing Diet planning in people with Acute Coronary Syndrome and Hypertension, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
Trial summary
The clinical trail study aimed to determine effect of DASH eating plan on cardiac parameters and quality of life in hypertensive individuals diagnosed with acute coronary syndrome. The main questions it aims to answer are: 1. DASH diet improve quality of life? 2. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Acute Coronary Syndrome, Hypertension
- What is being tested?
- Diet planning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 1 Sep 2021
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with acute coronary syndrome within the last month
- with a measured blood pressure above 140/90 mmHg or using antihypertensive drugs
- not obese (body mass index < 30)
- not diagnosed with a disease requiring a different medical nutrition therapy (chronic renal failure, diabetes, cancer, etc.)
- volunteered to participate in the study
Who cannot join
- Acute coronary syndrome diagnosed more than 1 month ago
- obese (body mass index > 30 )
- without hypertension
- receiving different medical nutrition therapy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bandırma Onyedi Eylul University
Balıkesir, Bandırma, 10200
About this study
Official title: The Effect of the DASH (Dietary Approaches to Stop Hypertension) Diet on Quality of Life and Cardiac Parameters in Patients Acute Coronary Syndrome With Hypertension
The clinical trail study aimed to determine effect of DASH eating plan on cardiac parameters and quality of life in hypertensive individuals diagnosed with acute coronary syndrome.
The main questions it aims to answer are:
- DASH diet improve quality of life?
- DASH diet improve cardiac parameters?
The researchers assessed the results of 12 weeks of the DASH diet.
Patients will apply the DASH diet prepared individually by the researchers for 12 weeks.
Read the detailed description
The study period was 12 weeks. Patients' food consumption (3 day), anthropometric measurements, blood pressure measurements, physical activity levels, biochemical and cardiac parameters, adherence to DASH eating plan and the MacNew Heart Health-Related Quality of Life Scale were recorded at the beginning of the study and at the end of 12 weeks.
- Conditions
- Acute Coronary Syndrome, Hypertension
- Being tested
- Diet planning
- Keywords
- acute coronary syndrome, hypertension, DASH diet, quality of life, cardiac parameters
- Medical subject headings
- Acute Coronary Syndrome, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet planningOther
Healthy eating planning
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The daily energy requirement of the individuals included in the study was obtained by multiplying the physical activity level (PAL) calculated as a result of 24-hour physical activity recording and the Harris-Benedict formula used to calculate the basal metabolic rate.
Harris-Benedict Formula Male 66.5 + 13.75 x Weight (kg) + 5.003 x Height (cm) - 6.775 x Age (years) Female 655.1 + 9.563 x Weight (kg) + 1.85 x Height (cm) - 4.676 x Age (years)
After the daily energy requirement was calculated, a DASH eating plan specific to the individuals was created and they were asked to maintain it for 12 weeks. In addition, the personal contact information of the researcher was shared with the individuals and they were in constant communication about all questions related to the nutrition plan. Receives: Other: Diet planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (MacNew Heart Disease Health-Related Quality of Life Scale)
The quality of life of the patients at the beginning of the study and at the end of the 12th week was assessed with the MacNew Heart Disease Health-Related Quality of Life Scale. The scale is a different form of the Post-MI Quality of Life Scale, which was developed to determine especially depression and anxiety in patients with acute MI (Myocardial Infarction) and which can be evaluated by patients responding to the scale. The scale can be used in different cardiac patients such as MI, angina pectoris and heart failure patients and there is a high correlation between it and other tools that assess quality of life. MacNew Heart Disease Health-Related Quality of Life Scale consists of three sub-dimensions (emotional, physical and social) and 27 items in 7-point Likert type. The answer to each item is between 1-7. A low score indicates poor quality of life, while a high score indicates better quality of life.
Measured: 12 week
Ejection Fraction (%)
A measurement of the percentage of blood leaving the heart each time it squeezes (using echocardiographic imaging)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jun 2020
- Primary completion1 Nov 2020
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This clinical trial is a single-group, pre-post design. In this model, quality of life and cardiac parameters were assessed before and after individualised DASH diet.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hacı Ömer YILMAZ, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485765
- Sponsor's protocol ID
- hcmrylmz-2024
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be shared after the data is obtained and analysed
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the DASH (Dietary Approaches to Stop Hypertension) Diet on Quality of Life and Cardiac Parameters in Patients Acute Coronary Syndrome With Hypertension
- ClinicalTrials.gov ID
- NCT06485765
- Acronym / sponsor ID
- hcmrylmz-2024
- Conditions
- Acute Coronary Syndrome, Hypertension
- Keywords
- acute coronary syndrome, hypertension, DASH diet, quality of life, cardiac parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 3 Jul 2024 (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.
The clinical trail study aimed to determine effect of DASH eating plan on cardiac parameters and quality of life in hypertensive individuals diagnosed with acute coronary syndrome.
The main questions it aims to answer are:
- DASH diet improve quality of life?
- DASH diet improve cardiac parameters?
The researchers assessed the results of 12 weeks of the DASH diet.
Patients will apply the DASH diet prepared individually by the researchers for 12 weeks.
Detailed description
The study period was 12 weeks. Patients' food consumption (3 day), anthropometric measurements, blood pressure measurements, physical activity levels, biochemical and cardiac parameters, adherence to DASH eating plan and the MacNew Heart Health-Related Quality of Life Scale were recorded at the beginning of the study and at the end of 12 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This clinical trial is a single-group, pre-post design. In this model, quality of life and cardiac parameters were assessed before and after individualised DASH diet.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Diet planningThe daily energy requirement of the individuals included in the study was obtained by multiplying the physical activity level (PAL) calculated as a result of 24-hour physical activity recording and the Harris-Benedict formula used to calculate the basal metabolic rate. Harris-Benedict Formula Male 66.5 + 13.75 x Weight (kg) + 5.003 x Height (cm) - 6.775 x Age (years) Female 655.1 + 9.563 x Weight (kg) + 1.85 x Height (cm) - 4.676 x Age (years) After the daily energy requirement was calculated, a DASH eating plan specific to the individuals was created and they were asked to maintain it for 12 weeks. In addition, the personal contact information of the researcher was shared with the individuals and they were in constant communication about all questions related to the nutrition plan. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosed with acute coronary syndrome within the last month
- with a measured blood pressure above 140/90 mmHg or using antihypertensive drugs
- not obese (body mass index < 30)
- not diagnosed with a disease requiring a different medical nutrition therapy (chronic renal failure, diabetes, cancer, etc.)
- volunteered to participate in the study
Key exclusion criteria (4 listed)
- Acute coronary syndrome diagnosed more than 1 month ago
- obese (body mass index > 30 )
- without hypertension
- receiving different medical nutrition therapy
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 planningHealthy eating planning | Other | Intervention group |
Primary outcome
Quality of Life (MacNew Heart Disease Health-Related Quality of Life Scale)
Time frame: 12 week
The quality of life of the patients at the beginning of the study and at the end of the 12th week was assessed with the MacNew Heart Disease Health-Related Quality of Life Scale. The scale is a different form of the Post-MI Quality of Life Scale, which was developed to determine especially depression and anxiety in patients with acute MI (Myocardial Infarction) and which can be evaluated by patients responding to the scale. The scale can be used in different cardiac patients such as MI, angina pectoris and heart failure patients and there is a high correlation between it and other tools that assess quality of life. MacNew Heart Disease Health-Related Quality of Life Scale consists of three sub-dimensions (emotional, physical and social) and 27 items in 7-point Likert type. The answer to each item is between 1-7. A low score indicates poor quality of life, while a high score indicates better quality of life.
Ejection Fraction (%)
Time frame: 12 weeks
A measurement of the percentage of blood leaving the heart each time it squeezes (using echocardiographic imaging)
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 3 Jul 2024.
- Individual participant dataSharing planned: Yes. The data will be shared after the data is obtained and analysed
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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.
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 planning in people with Acute Coronary Syndrome and Hypertension, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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 3 Jul 2024. 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 Turkey (Türkiye). 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?
Quality of Life (MacNew Heart Disease Health-Related Quality of Life Scale) (time frame: 12 week). The study lists 2 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 3 Jul 2024.