Combining a Mediterranean Diet With Physical Activity to Address Cardiometabolic Risk

NCT03731013 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-06-14

No results posted yet for this study

Summary

There is little doubt scientifically that healthy eating, such as adhering to the Mediterranean diet (MedDiet) principles, is key for the prevention of cardiovascular disease (CVD). There is also convincing evidence for a strong inverse relationship between moderate intensity physical activity (PA) and mortality. Surprisingly, no study has yet formally documented how the combination of a MedDiet and regular PA improves cardiometabolic health in high-risk individuals. Why is this an important issue to address? On the one hand, a rigorous demonstration that the combination of a healthy diet and PA is better than the sum of each part in terms of cardiometabolic benefits will underpin the importance of advocating the combination of both modalities systematically to maximize health effects. Alternatively (and provocatively), results showing that healthy eating and PA have non-additive or non-synergistic effects will imply that one needs to adhere to only one of these two lifestyle modalities to maximizes cardiometabolic benefits. The overarching aim of this research is to test the hypothesis that consumption of a MedDiet combined with PA do act synergistically to improve cardiometabolic risk. The investigators hypothesize that healthy eating and PA act in synergy to reduce postprandial lipemia, a powerful independent risk factor for coronary heart disease.

Conditions

  • Cardiometabolic Risk

Interventions

BEHAVIORAL

Mediterranean diet (MedDiet)

Participants randomized in the Mediterranean diet group without physical activity will be instructed and supported towards adhering to principles of the Mediterranean diet, without changes in physical activity habits.

BEHAVIORAL

Physical activity (PA)

Participants randomized in the group physical activity without Mediterranean diet will participate in a structured, supervised PA program to achieve 150 min of moderate PA per week, without changes in dietary habits.

BEHAVIORAL

Mediterranean diet and physical activity

The combination group (MedDiet + PA) will receive the combination of both interventions.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • Laval University

    lead OTHER

Principal Investigators

  • Benoît Lamarche, PhD · Laval University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-22
Primary Completion
2023-04-24
Completion
2023-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03731013 on ClinicalTrials.gov