Hypocaloric Mediterranean Diet or Physical Activity to Lower Cardiometabolic Risk

Not Applicable

Recruiting

• Conditions: Hypertension; Obesity, Abdominal; Overweight or Obesity
• Interventions: Behavioral: Physical activity; Behavioral: Hypocaloric Mediterranean diet

• Registration Number: NCT04155112
• Lead Sponsor: Oslo University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-11-04
• Study First Posted: 2019-11-07
• Study Start: 2023-04-21
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-05
• Last Update Posted: 2023-05-09
• Primary Completion: 2024-10
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical activity (PA)	Physical activity	For 6 months, the participants will be recommended to increase physical activity to ≥ 150 min of moderate intensity or ≥ 75 min of vigorous intensity aerobic PA (or an equivalent combination) and ≥ 2 days of resistance exercise a week. The participants will take part in supervised group classes, twice per week. Each participant will receive a heart rate monitor to bring home and to use while reporting activity via a physical activity diary.
Hypocaloric Mediterranean diet (MeDi)	Hypocaloric Mediterranean diet	For 6 months, the participants will be recommended to consume a diet for 5-10% body weight loss. This diet will be based on the Mediterranean diet pattern. For the 6 months of the intervention, the participants will weigh themselves weekly and report their progress to the investigator. Adaptations to the diet will be made to ensure the goal of 5-10% weight loss is achieved. Each participant will receive a scale to bring home and to use while reporting weight loss.

Primary Outcome Measures

Name	Time	Method
Change in 24-hour ambulatory DBP among subjects, after 6 months.	baseline to 6 months	24-hour ambulatory blood pressure will be measured with a device that allows free-living.; Change = (6 month measurement - baseline measurement).
Change in 24-hour ambulatory SBP among subjects, after 6 months.	Baseline to 6 months	24-hour ambulatory blood pressure will be measured with a device that allows free-living.; Change = (6 month measurement - baseline measurement).

Secondary Outcome Measures

Name	Time	Method
Change in other measures of blood pressure, within and among subjects, after 6 and 12 months.	Baseline to 6 months, baseline to 12 months	Blood pressure will be measured with 24-hour ambulatory blood pressure monitors and in-office. Other measures of blood pressure include daytime blood pressure, nighttime blood pressure, and office systolic and diastolic blood pressure.; Change = (6 or 12 month measurement - baseline measurement)
Change in body composition, within and among subjects, after 6 months.	Baseline to 6 months	Office measures of body composition will include weight, waist and hip circumferences, BMI, waist-to-hip ratio, and bioimpedance analysis (BIA). Additional measures of body composition will be acquired via Dual-energy X-ray absorptiometry (DXA), including fat mass, fat-free body mass, visceral adipose tissue, subcutaneous adipose tissue, and bone mineral content and density.; Change = (6 month measurement - baseline measurement)
Change in safety outcomes, within and among subjects, after 6 and 12 months.	Baseline to 6 months, baseline to 12 months	Safety outcomes will be measured via blood tests (including hematology, kidney, liver, and thyroid markers).; Change = (6 or 12 month measurement - baseline measurement)
Change in markers of cardiometabolic risk, within and among subjects, after 6 and 12 months.	Baseline to 6 months, baseline to 12 months	Cardiometabolic risk factors (including measures of glucose regulation, blood lipids, NORRISK 2 score, metabolic syndrome) will be measured via blood samples and additional clinical parameters.; Change = (6 or 12 month measurement - baseline measurement)
Change in inflammation markers, within and among subjects, after 6 and 12 months.	Baseline to 6 months, baseline to 12 months	Inflammation markers will be measured via blood tests (including CRP and differential leucocyte count).; Change = (6 or 12 month measurement - baseline measurement)

Trial Locations

Locations (1)

Oslo University Hospital, Aker; 🇳🇴 Oslo, Norway