Clinical trial NCT04155112: Hypocaloric Mediterranean Diet or Physical Activity to Lower Cardiometabolic Risk
Official title: Hypocaloric Mediterranean Diet or Physical Activity to Lower Cardiometabolic Risk in Vulnerable Populations: the MeDiPA Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight or Obesity
Obesity, Abdominal
Hypertension
Keywords: Hypertension
Lifestyle
Mediterranean diet
Physical activity
Weight loss
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: The National Association for Public Health, Norway
First posted: 2019-11-07
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Change in 24-hour ambulatory SBP among subjects, after 6 months.
timeFrame: Baseline to 6 months
measure: Change in 24-hour ambulatory DBP among subjects, after 6 months.
timeFrame: baseline to 6 months
Secondary outcomes:
measure: Change in other measures of blood pressure, within and among subjects, after 6 and 12 months.
timeFrame: Baseline to 6 months, baseline to 12 months
measure: Change in body composition, within and among subjects, after 6 months.
timeFrame: Baseline to 6 months
measure: Change in markers of cardiometabolic risk, within and among subjects, after 6 and 12 months.
timeFrame: Baseline to 6 months, baseline to 12 months
measure: Change in inflammation markers, within and among subjects, after 6 and 12 months.
timeFrame: Baseline to 6 months, baseline to 12 months
measure: Change in safety outcomes, within and among subjects, after 6 and 12 months.
timeFrame: Baseline to 6 months, baseline to 12 months
Other outcomes:
measure: Change in quality of life, within and among subjects, after 3, 6 and 12 months.
timeFrame: Baseline to 6 months, baseline to 12 months
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Aker
Study officials:
affiliation: Oslo University Hospital
name: Kari Anne Sveen, MD, PhD
role: STUDY_CHAIR
References: