- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04155112
Hypocaloric Mediterranean Diet or Physical Activity to Lower Cardiometabolic Risk (MeDiPA)
Hypocaloric Mediterranean Diet or Physical Activity to Lower Cardiometabolic Risk in Vulnerable Populations: the MeDiPA Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patient with obesity and ectopic fat (examples: visceral, pancreatic, intramuscular, hepatic) and risk og type 2 diabetes and cardiovascular disease (CVD) benefit from interventions that lower body weight. Diet and physical activity are optimal. Adherence to a Mediterranean diet with and without weight loss reduce the incidence of CVD and was superiour to a low fat diet in lowering ectopic fat. Exercise lowers risk of type 2 diabetes and contributes to weight loss. Addition of exercise after 6 month of dieting decreased visceral fat without weight loss, suggesting that reduction in ectopic fat in addition to increased lean body mass explain the benefits of exercise.
Poor motivation, physical limitations, socioeconomic factors and lack of enjoyment of exercise are common. and represent a major barrier to lifestyle change. Initiating one lifestyle change at a time (diet or exercise) may improve adherence.
Studies examining the effects og lifestyle change on disease outcomes are difficult to conduct due to long follow up and large samples required. In the abscence of of hard outcomes, surrogate endpoints are of considerable importance in guiding lifestyle advice. Recently software has been developed to quantify ectopic fat deposits using MRI technology.
To our knowledge, studies looking at the differential effects of dietary change versus physical activity on ectopic fat deposits using advanced technology have not been done.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kari Anne Sveen, MD, PhD
- Phone Number: 0047 915 02 770
- Email: kasvee@ous-hf.no
Study Contact Backup
- Name: Ana Sousa, MSc
- Phone Number: 0047 230 33 588
- Email: anaseq@ous-hf.no
Study Locations
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-
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Oslo, Norway, 0424
- Recruiting
- Oslo University Hospital, Aker
-
Contact:
- Kari Anne Sveen, MD, PhD
- Email: kasvee@ous-hf.no
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Physical activity (PA)
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.
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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).
Other Names:
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Experimental: Hypocaloric Mediterranean diet (MeDi)
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.
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Energy deficit to reach 5-10% weight loss within 6 months, based on the Mediterranean diet pattern.
Other Names:
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No Intervention: Control
At baseline, participants will receive usual care, which consists of general information regarding the importance of lifestyle for BP.
This information will not be reinforced throughout the study duration.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in 24-hour ambulatory SBP among subjects, after 6 months.
Time Frame: 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). |
Baseline to 6 months
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Change in 24-hour ambulatory DBP among subjects, after 6 months.
Time Frame: 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). |
baseline to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in other measures of blood pressure, within and among subjects, after 6 and 12 months.
Time Frame: Baseline to 6 months, baseline to 12 months
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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
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Change in body composition, within and among subjects, after 6 months.
Time Frame: Baseline to 6 months
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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
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Change in markers of cardiometabolic risk, within and among subjects, after 6 and 12 months.
Time Frame: Baseline to 6 months, baseline to 12 months
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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
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Change in inflammation markers, within and among subjects, after 6 and 12 months.
Time Frame: Baseline to 6 months, baseline to 12 months
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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
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Change in safety outcomes, within and among subjects, after 6 and 12 months.
Time Frame: Baseline to 6 months, baseline to 12 months
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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
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in quality of life, within and among subjects, after 3, 6 and 12 months.
Time Frame: Baseline to 6 months, baseline to 12 months
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Quality of life will be measured via the EQ-5D questionnaire.
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Baseline to 6 months, baseline to 12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Kari Anne Sveen, MD, PhD, Oslo University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/696
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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