Effects of the DASH vs. the Mediterranean Diet Combined With Salt Restriction on Blood Pressure Levels in Adults

NCT05669404 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2023-09-13

No results posted yet for this study

Summary

Non-pharmacological measures should serve as the first-line treatment in individuals with high normal blood pressure (BP) levels or grade 1 hypertension and low-moderate cardiovascular disease risk. Salt intake reduction and the dietary patterns of the Dietary Approaches to Stop Hypertension (DASH) diet and the Mediterranean diet (MedDiet) have been recognized as effective dietary measures for BP reduction. To the best of our knowledge, no clinical trials were designed to compare the effects of these dietary strategies. The purpose of the present trial was to compare the effects of salt restriction, the DASH, and the MedDiet combined with the salt restriction on BP levels and cardiometabolic risk factors in adults with high normal BP or grade 1 hypertension over 3 months.

Conditions

Interventions

BEHAVIORAL

Salt Restriction Group (SRG)

Patients assigned to the SRG continued to consume their usual diet, but they had to restrict their sodium intake to 2,000 mg/ day. They were given a detailed booklet containing information about table salt, foods rich in sodium, and practical ways to decrease salt consumption. During each 45-min individual session, they received intensive counselling and training to increase adherence to salt restriction. Also, they were instructed to keep their body weight stable and not to change their physical activity level over the next 3 months.

BEHAVIORAL

DASH Diet combined with salt restriction Group (DDG)

Patients assigned to the DDG received a more extensive booklet, which which in addition to the information regarding salt restriction, contained detailed information about the DASH diet, and practical advice about how to start and stay on the assigned dietary pattern. In addition to the booklet, each patient received an individualized eating plan with six sample daily menus, incorporating the goals of the DASH diet. During the 45-min individual sessions, patients were intensively counselled and trained to increase adherence to salt restriction and the assigned dietary pattern. Also, they were instructed to keep their body weight stable and not to change their physical activity level over the next 3 months.

BEHAVIORAL

Mediterranean Diet combined with salt restriction Group (MDG)

Patients assigned to the MDG received a more extensive booklet, which which in addition to the information regarding salt restriction, contained detailed information about the MedDiet, and practical advice about how to start and stay on the assigned dietary pattern. In addition to the booklet, each patient received an individualized eating plan with six sample daily menus, incorporating the goals of the MedDiet diet. During the 45-min individual sessions, patients were intensively counselled and trained to increase adherence to salt restriction and the assigned dietary pattern. Also, they were instructed to keep their body weight stable and not to change their physical activity level over the next 3 months.

Sponsors & Collaborators

  • Hippocration General Hospital

    lead OTHER

Principal Investigators

  • Konstantinos P Tsioufis, Prof. · First Cardiology Clinic, Hippocration General Hospital, NKUA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-07
Primary Completion
2022-05-27
Completion
2022-09-09

Countries

  • Greece

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05669404 on ClinicalTrials.gov