Hypocaloric Mediterranean Diet or Physical Activity to Lower Cardiometabolic Risk

Launched by OSLO UNIVERSITY HOSPITAL · Nov 4, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how a low-calorie Mediterranean diet or increased physical activity can help lower blood pressure in people who are overweight or obese and are already taking two or more medications to manage their high blood pressure. The goal is to see if these lifestyle changes can make a difference for individuals who still have high blood pressure despite their current treatment. The study will involve three groups: one group will follow the Mediterranean diet, another will focus on physical activity, and the third group will receive regular care without any additional interventions.

To participate, individuals need to be between 18 and 70 years old, have a body mass index (BMI) between 25 and 40, and be taking at least two antihypertensive medications. They should also have a waist measurement that is higher than certain limits and should not be very active (less than 150 minutes of moderate exercise per week). Over the course of six months, participants will attend four study visits to monitor their progress, and the study will follow up with them for an additional six months. This trial is currently recruiting participants, and it’s a great opportunity for those looking to improve their health through diet and exercise.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Men and women
• • 18 - 70 years
• • Taking ≥ 2 antihypertensive drugs (includes combination therapy)
• • Office SBP ≥ 140mmHg and/or DBP ≥ 90mmHg on two occasions
• • BMI 25 - 40 kg/m2
• • Waist circumference ≥ 88 cm (women) or ≥ 102 cm (men)
• • Sedentary lifestyle (\< 150 minutes/week of moderate intensity physical activity)
• • Weight stable (± 5 kg in the last 6 months)
• • Not on a weight loss diet
• • Willing to comply to an intervention of either a hypocaloric Mediterranean diet or physical activity (or control) for 6 months
• Exclusion Criteria:
• • Unable to provide informed consent
• • Pregnant or lactating
• • Office BP ≥ 160/100 mmHg
• • Diabetes mellitus type 1
• • History of cardiovascular disease (including uncompensated heart failure, recent infarction or stroke in the last 6 months, severe arrhythmia, heart failure or unstable angina pectoris)
• • Chronic kidney disease stages 4 or 5
• • Cancer in the last 5 years
• • Changes in concurrent medication (anti-hypertensives, anti-diabetics, lipid-lowering drugs) in the last 3 months
• • Regular use of oral corticosteroids in excess of 5 mg prednisolone (or equivalent) during the last month
• • Use of GLP-1 analogues for \< 1 year
• • Drug or alcohol abuse
• • Eating disorders or severe dietary restrictions
• • Impediments to physical activity at recommended levels due to musculoskeletal and other conditions.