Combining a Mediterranean Diet With Physical Activity to Address Cardiometabolic Risk

NCT03731013 | Completed

• 1 other identifier: INAF-MEx 21628
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 1. Serum 4-hour post-prandial TG concentrations

  Serum TG concentrations (mmol/l) will be measured 4 hours after ingestion of a fatty meal (fat load), at the end of the 16-week intervention in all subjects in each group. The fat load will be conducted 48 hours after the last exercise training session in the PA groups (hence at 16.2 weeks, or 114 days). Analyses will be adjusted for 4-hr postprandial TG values measured at baseline.

  16.3 week (114 days)

Secondary Outcomes (24)

• Serum fasting TG concentrations

  16 week (112 days)

• Serum fasting TG concentrations

  16.3 week (114 days)

• Serum fasting LDL-C concentrations

  16 week (112 days)

• Serum fasting LDL-C concentrations

  16.3 week (114 days)

• Serum fasting HDL-C concentrations

  16 week (112 days)

Other Outcomes (2)

• Change (week 0 vs week 16) in android obesity

  week 0 and week 16 (112 days)

• Gut microbiota

  16 week (112 days)

Study Arms (4)

Mediterranean diet (MedDiet)

EXPERIMENTAL

Behavioral: Mediterranean diet (MedDiet)

Physical activity (PA)

EXPERIMENTAL

Behavioral: Physical activity (PA)

Mediterranean diet and physical activity

EXPERIMENTAL

Behavioral: Mediterranean diet and physical activity

Control

NO INTERVENTION

Interventions

Mediterranean diet (MedDiet) BEHAVIORAL

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.

Mediterranean diet (MedDiet)

Physical activity (PA) BEHAVIORAL

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.

Physical activity (PA)

Mediterranean diet and physical activity BEHAVIORAL

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

Mediterranean diet and physical activity

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Waist circumference of 80 cm and over for women and 94 cm and over for men
• Serum triglyceride concentration of 1.5 mmol/L or higher
• For pre-menopausal women: regular cycle for at least 3 months, do not become pregnant or breastfeed
• For menopausal women: no hormone or stable dose for at least 6 months

You may not qualify if:

• Have a calculated Mediterranean score \> 25
• Do \> 100 minutes of moderate physical activity per week
• Weight change of \> 5 kg in the last 3 months
• Presence of familial hypercholesterolemia, diabetes, history of CVD
• Take medications that affect inflammation and blood lipids
• Have taken anti-diabetic agents in the last 6 months
• Smoker
• Alcohol consumption \>14 drinks per week
• Have allergies or aversions to components of the Mediterranean diet
• Follow a structured training program
• Dieting or having a special diet
• Inability to engage in a physical activity program

Sponsors & Collaborators

• Laval University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Institute of Nutrition and Funtional Foods

Québec, G1V 0A6, Canada

Location

MeSH Terms

Interventions

Diet, Mediterranean; Exercise

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Benoît Lamarche, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study director

Model Details: Parallel group 2x2 factorial design clinical trial according to which participants will be randomly assigned to one of four 16-week intervention groups: 1- Mediterranean Diet alone; 2- Physical Activity alone ; 3- Combination of Mediterranean Diet and Physical Activity; 4- Control Group (no intervention).

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: November 6, 2018
• Study Start: October 22, 2018
• Primary Completion: April 24, 2023
• Study Completion: December 31, 2023
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

CA (1)