Hypocaloric Mediterranean Diet or Physical Activity to Lower Cardiometabolic Risk (MeDiPA)

May 5, 2023 updated by: Kari Anne Sveen, Oslo University Hospital

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

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

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kari Anne Sveen, MD, PhD
  • Phone Number: 0047 915 02 770
  • Email: kasvee@ous-hf.no

Study Contact Backup

Study Locations

      • Oslo, Norway, 0424
        • Recruiting
        • Oslo University Hospital, Aker
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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:
  • PA
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.
Energy deficit to reach 5-10% weight loss within 6 months, based on the Mediterranean diet pattern.
Other Names:
  • MeDi
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.

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
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

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
Change in body composition, within and among subjects, after 6 months.
Time Frame: 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)

Baseline to 6 months
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

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
Change in inflammation markers, within and among subjects, after 6 and 12 months.
Time Frame: 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)

Baseline to 6 months, baseline to 12 months
Change in safety outcomes, within and among subjects, after 6 and 12 months.
Time Frame: 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)

Baseline to 6 months, baseline to 12 months

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
Quality of life will be measured via the EQ-5D questionnaire.
Baseline to 6 months, baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Kari Anne Sveen, MD, PhD, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2023

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

September 1, 2025

Study Registration Dates

First Submitted

October 23, 2019

First Submitted That Met QC Criteria

November 4, 2019

First Posted (Actual)

November 7, 2019

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 5, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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