Hypertension DASH Diet and Salt Free Diet

• Sponsor: Nuh Naci Yazgan University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06117072
• Collaborator: TC Erciyes University (Other)
• Enrollment: 60
• Location: 1
• Arm: 1
• Actual Duration (Months): 8.5
• Patients Per Site Per Month: 7.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Nutritional Status; Diet, Healthy; Blood Pressure; Salt; Deficit (or Low)	Other: diet plan	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: 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.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.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Which Is More Effective in Hypertension?: Salt-Free Diet vs. DASH Diet
• Actual Study Start Date: Jul 1, 2019
• Actual Primary Completion Date: Mar 15, 2020
• Actual Study Completion Date: Mar 15, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Dash diet group, salt free diet 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.

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

Outcome Measures

Primary Outcome Measures

1. comparison of blood pressure measurements [two months]

   blood pressure (mmHg)

2. comparison of anthropometric measurements [two months]

   body weight (kg)

3. comparison of anthropometric measurements [two months]

   height (m)

4. comparison of anthropometric measurements [two months]

   body mass index (kg/m2)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asli Gizem Çapar	Kayseri	Kayseri̇	Turkey	38020

Sponsors and Collaborators

• Nuh Naci Yazgan University
• TC Erciyes University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aslı Gizem Çapar, Principal Investigator, Nuh Naci Yazgan University
• ClinicalTrials.gov Identifier: NCT06117072
• Other Study ID Numbers: NuhNaciYU
• First Posted: Nov 3, 2023
• Last Update Posted: Nov 3, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of Nov 3, 2023