NCT06117072

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed
Last Updated

November 3, 2023

Status Verified

October 1, 2023

Enrollment Period

9 months

First QC Date

October 19, 2023

Last Update Submit

October 31, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • comparison of blood pressure measurements

    blood pressure (mmHg)

    two months

  • comparison of anthropometric measurements

    body weight (kg)

    two months

  • comparison of anthropometric measurements

    height (m)

    two months

  • comparison of anthropometric measurements

    body mass index (kg/m2)

    two months

Study Arms (1)

Dash diet group, salt free diet

EXPERIMENTAL

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

Interventions

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

Dash diet group, salt free diet

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hypertension at least four weeks prior and had not changed their drug regimen in the previous four weeks
  • 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

You may not qualify if:

  • Those with chronic diseases other than cardiovascular diseases (such as Type II diabetes, kidney disease, cancer disease)
  • Using alcohol or smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asli Gizem Çapar

Kayseri, Kayseri̇, 38020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 19, 2023

First Posted

November 3, 2023

Study Start

July 1, 2019

Primary Completion

March 15, 2020

Study Completion

March 15, 2020

Last Updated

November 3, 2023

Record last verified: 2023-10

Locations