DASH Diet, Quality of Life and Cardiac Parameters of Patients With Acute Coronary Syndrome

NCT06485765 | Completed

• 1 other identifier: hcmrylmz-2024
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 1.DASH diet improve quality of life?
2. 2.DASH diet improve cardiac parameters?

Conditions

Acute Coronary Syndrome; Hypertension

Keywords

acute coronary syndrome; hypertension; DASH diet; quality of life; cardiac parameters

Outcome Measures

Primary Outcomes (2)

• 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.

  12 week

• Ejection Fraction (%)

  A measurement of the percentage of blood leaving the heart each time it squeezes (using echocardiographic imaging)

  12 weeks

Study Arms (1)

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.

Other: Diet planning

Interventions

Diet planning OTHER

Healthy eating planning

Intervention group

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Acute coronary syndrome diagnosed more than 1 month ago
• obese (body mass index \> 30 )
• without hypertension
• receiving different medical nutrition therapy

Sponsors & Collaborators

• Bandırma Onyedi Eylül University: lead

Study Sites (1)

Bandırma Onyedi Eylul University

Balıkesir, Bandırma, 10200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Hypertension

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (PhD)

Model Details: 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.

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: July 3, 2024
• Study Start: June 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: September 1, 2021
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 12 months

Locations

TU (1)