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Completed
NCT05669404
Effects of the DASH vs. the Mediterranean Diet Combined With Salt Restriction on Blood Pressure Levels in Adults
Conditions: Hypertension
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 240
Sponsor: Hippocration General Hospital
Location: Greece
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.
Eligibility Criteria
Inclusion Criteria: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.Exclusion Criteria: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.Body Mass Index >40 kg/m2.Current alcohol consumption >14 drinks per week.Current or planned pregnancy before the end of the study, or breast-feeding.Any concomitant conditions that in the opinion of the investigator interfere with the diet or other situations requiring specific nutritional management.
Source: ClinicalTrials.gov (NCT05669404). StuddyBuddy aggregates publicly available trial information.