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Clinical Trial Summary

The purpose of this randomized controlled trial is to test the effects of a hypocaloric Mediterranean diet or of physical activity in participants who take at least 2 antihypertensive drugs but do not reach blood pressure treatment goal. This study is a randomized, controlled, single-center, parallel group trial with three arms: hypocaloric Mediterranean diet (MeDi), physical activity (PA), or control. The control group will receive usual care (no intervention). This study will not be blinded. The interventions will last 6 months, while the study follow-up will last 12 months. Four study visits will take place: baseline, at 3 months, at 6 months, at 12 months. The primary outcome is change in mean 24-hour ambulatory systolic blood pressure and diastolic blood pressure among groups after 6 months of intervention. Secondary and exploratory outcomes include change in other measures of blood pressure, body composition, other markers of cardiometabolic disease, inflammation markers, safety outcomes, and quality of life, among others.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04155112
Study type Interventional
Source Oslo University Hospital
Contact Kari Anne Sveen, MD, PhD
Phone 0047 915 02 770
Email kasvee@ous-hf.no
Status Recruiting
Phase N/A
Start date April 21, 2023
Completion date September 2025

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