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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06117072
Other study ID # NuhNaciYU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2019
Est. completion date March 15, 2020

Study information

Verified date October 2023
Source Nuh Naci Yazgan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background: In the management of hypertension lifestyle changes are recommended along with pharmacological treatment. Aims: This randomized controlled intervention study aimed to compare the effects of a Dietary Approaches to Stop Hypertension (DASH) diet and a salt-free diet on blood pressure in hypertension patients. Methods: This study was conducted with 60 patients with primary hypertension. One group (n=30) was given an individualized DASH diet, the other group was given a salt-free diet (n=30), and the participants were followed for two months. The patients' blood pressures were monitored daily throughout the study, and their biochemical parameters were monitored at the beginning of the study, in the first and second months.


Description:

This study, which was planned as a randomized controlled intervention study, was conducted to compare the effects of the Dietary Approaches to Stop Hypertension (DASH) and salt-free diet on blood pressure in patients with hypertension. The study was complited with the participation of 60 hypertensive individuals (46 females, 14 males) who applied to between July 2019 and March 2020. Patients with hypertension who were living in Kayseri province, at least elementary school graduate, in the 20-65 age group, able to communicate with the researcher face to face and by phone, diagnosed with hypertension at least 4 weeks ago, and whose medication did not change were included in the study. One group (n = 30) received the DASH diet and the other group received a salt-free diet (n = 30) and was followed for 2 months. Research data was repeated during application with the face-to-face interview method. Research data was collected through a questionnaire containing questions about the sociodemographic characteristics, nutritional habits, chronic diseases, and medications of the individuals. Anthropometric measurements of the patients were made and blood and urine samples were taken. Food consumption frequency was noted, DASH diet compliance scale and International Physical Activity Questionnaire (IPAQ) short form were applied.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 15, 2020
Est. primary completion date March 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria: - Hypertension at least four weeks prior and had not changed their drug regimen in the previous four weeks - 20-65 age group - At least primary school graduate - Able to express himself verbally - Volunteer to participate in the dietary intervention - Able to communicate with the researcher face to face and by phone Exclusion Criteria: - Those with chronic diseases other than cardiovascular diseases (such as Type II diabetes, kidney disease, cancer disease) - Using alcohol or smoking

Study Design


Intervention

Other:
diet plan
One group (n = 30) received the DASH diet and the other group received a salt-free diet (n = 30) and was followed for 2 months

Locations

Country Name City State
Turkey Asli Gizem Çapar Kayseri Kayseri?

Sponsors (2)

Lead Sponsor Collaborator
Nuh Naci Yazgan University TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary comparison of blood pressure measurements blood pressure (mmHg) two months
Primary comparison of anthropometric measurements body weight (kg) two months
Primary comparison of anthropometric measurements height (m) two months
Primary comparison of anthropometric measurements body mass index (kg/m2) two months
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