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

NCT05669404 | Completed

• 1 other identifier: The DASH-MedDiet study
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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

Hypertension

Keywords

Hypertension; Blood pressure; Diet; Salt; Dietary Approaches to Stop Hypertension; Mediterranean; Dietary pattern

Outcome Measures

Primary Outcomes (1)

• Office systolic blood pressure (BP)

  The attained mean office systolic BP difference among the randomized arms

  3 months post-intervention

Secondary Outcomes (4)

• Office diastolic blood pressure (BP)

  3 months post-intervention

• Ambulatory systolic and diastolic blood pressure (BP)

  3 months post-intervention

• Odds of hypertension

  3 months post-intervention

• Metabolic syndrome and its components

  3 months post-intervention

Study Arms (4)

Control Group (CG)

NO INTERVENTION

Patients continued to consume their usual diet for 3 months

Salt Restriction Group (SRG)

EXPERIMENTAL

Patients continued to consume their usual diet, but they restricted sodium intake to 2,000 mg/ day for 3 months.

Behavioral: Salt Restriction Group (SRG)

DASH Diet combined with salt restriction Group (DDG)

EXPERIMENTAL

Patients consumed the DASH diet for 3 months.

Behavioral: DASH Diet combined with salt restriction Group (DDG)

Mediterranean Diet combined with salt restriction Group (MDG)

EXPERIMENTAL

Patients consumed the MedDiet diet for 3 months.

Behavioral: Mediterranean Diet combined with salt restriction Group (MDG)

Interventions

Salt Restriction Group (SRG) BEHAVIORAL

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.

Salt Restriction Group (SRG)

DASH Diet combined with salt restriction Group (DDG) BEHAVIORAL

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.

DASH Diet combined with salt restriction Group (DDG)

Mediterranean Diet combined with salt restriction Group (MDG) BEHAVIORAL

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.

Mediterranean Diet combined with salt restriction Group (MDG)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• High normal BP (office systolic BP: 130-139 mmHg and/or office diastolic BP: 85-89 mmHg) or grade 1 hypertension (office systolic BP: 140-159 mmHg and/or office diastolic BP: 90-99 mmHg) and low-moderate 10-year cardiovascular disease risk.
• Willingness to participate in a dietary intervention to control BP and to attend individual sessions.
• Signed informed consent form for participation.

You may not qualify if:

• Current use of anti-hypertensive medications.
• Current use of any other medications or agents affecting BP levels (e.g., nonsteroidal anti-inflammatory drugs).
• Use of food supplements accompanied by a refusal to discontinue them.
• Participation in a clinical study involving a drug or device within 3 months of screening.
• Active weight loss or participation in a weight loss treatment program within 3 months of screening.
• Secondary hypertension.
• Atomic history of cardiovascular disease (e.g. acute myocardial infarction, stroke, heart failure).
• Diabetes Mellitus (Type 1 \& 2).
• Chronic kidney disease, defined as an estimated Glomerular Filtration Rate (eGFR) \<60 mL/min/1.73m2.
• Liver disease (e.g., hepatitis, cirrhosis).
• Lung disease (e.g., chronic obstructive pulmonary disease).
• Inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
• Celiac disease.
• Active malignancy or cancer therapy.
• Current major psychiatric disorder or current drug abuse.

Sponsors & Collaborators

• Hippocration General Hospital: lead

Study Sites (1)

Hypertension Unit, First Cardiology Clinic, Hippocration General Hospital, National and Kapodistrian University of Athens

Athens, 11527, Greece

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Konstantinos P Tsioufis, Prof.

  First Cardiology Clinic, Hippocration General Hospital, NKUA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of this study, which was a dietary intervention evaluating the effect of certain dietary strategies on blood pressure levels and cardiometabolic risk factors, masking of the trial participants and the clinical dietician (sub-investigator), who provided the dietary education and was solely responsible for the assignment of patients to the study groups was not possible. However, patients were completely unaware of the other groups of the study and were treated according to strict criteria, preventing deviations from the intended intervention. Moreover, the principal investigator, care providers, and all members of the medical team, who conducted the office and the ambulatory BP measurements (outcomes assessors) were blinded to patients' allocations.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.D., FESC, FACC, Professor of Cardiology, National and Kapodistrian University of Athens, Greece, Head of the First Cardiology Clinic, Hippocration General Hospital

Model Details: Enrolled patients were blindly randomized with a 1:1:1:1 allocation to one of the four study groups, i.e., control group (CG), salt restriction group (SRG), DASH diet combined with salt restriction group (DDG), or MedDiet combined with salt restriction group (MDG).

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: December 30, 2022
• Study Start: January 7, 2019
• Primary Completion: May 27, 2022
• Study Completion: September 9, 2022
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)