Hypocaloric Mediterranean Diet or Physical Activity to Lower Cardiometabolic Risk

Hypertension Clinical Trial

— MeDiPA  

Official title:

Hypocaloric Mediterranean Diet or Physical Activity to Lower Cardiometabolic Risk in Vulnerable Populations: the MeDiPA Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04155112
• Other study ID #: 2019/696
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2023
• Est. completion date: September 2025

Study information

• Verified date: May 2023
• Source: Oslo University Hospital
• Contact: Kari Anne Sveen, MD, PhD
• Phone: 0047 915 02 770
• Email: kasvee[@]ous-hf.no
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Obesity
• Obesity, Abdominal
• Overweight
• Overweight or Obesity

Intervention

Behavioral:
• Physical activity
Increased physical activity to the minimum recommended by health authorities (= 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).
• Hypocaloric Mediterranean diet
Energy deficit to reach 5-10% weight loss within 6 months, based on the Mediterranean diet pattern.

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Aker	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	The National Association for Public Health, Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in quality of life, within and among subjects, after 3, 6 and 12 months.	Quality of life will be measured via the EQ-5D questionnaire.	Baseline to 6 months, baseline to 12 months
Primary	Change in 24-hour ambulatory SBP among subjects, after 6 months.	24-hour ambulatory blood pressure will be measured with a device that allows free-living.; Change = (6 month measurement - baseline measurement).	Baseline to 6 months
Primary	Change in 24-hour ambulatory DBP among subjects, after 6 months.	24-hour ambulatory blood pressure will be measured with a device that allows free-living.; Change = (6 month measurement - baseline measurement).	baseline to 6 months
Secondary	Change in other measures of blood pressure, within and among subjects, after 6 and 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)	Baseline to 6 months, baseline to 12 months
Secondary	Change in body composition, within and among subjects, after 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)	Baseline to 6 months
Secondary	Change in markers of cardiometabolic risk, within and among subjects, after 6 and 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)	Baseline to 6 months, baseline to 12 months
Secondary	Change in inflammation markers, within and among subjects, after 6 and 12 months.	Inflammation markers will be measured via blood tests (including CRP and differential leucocyte count).; Change = (6 or 12 month measurement - baseline measurement)	Baseline to 6 months, baseline to 12 months
Secondary	Change in safety outcomes, within and among subjects, after 6 and 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)	Baseline to 6 months, baseline to 12 months