Cardiometabolic RiskMExNCT03731013
Combining a Mediterranean Diet With Physical Activity to Address Cardiometabolic Risk
A study testing Mediterranean diet (MedDiet), Physical activity (PA) and Mediterranean diet and physical activity in people with Cardiometabolic Risk, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Risk
- What is being tested?
- Mediterranean diet (MedDiet), Physical activity (PA) and Mediterranean diet and physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 22 Oct 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mediterranean Diet and Physical Activity: is the Whole Better Than the Sum of Each Part ? Clinical and Mechanistic Perspectives
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.
Read the detailed description
This is a randomized study with a 2X2 experimental factorial design. A total of 200 men and women recruited in the Quebec City area via various media will participate in this study. Eligible participants will be randomly assigned to one of four 16-week intervention groups: 1- Mediterranean Diet (MedDiet); 2- Physical Activity (PA); 3- Combination of MedDiet and PA; 4- Control Group. Depending on the group, the intervention involves support for nutritional and PA components at different times, in groups or individually. The subjects assigned to the MedDiet will receive certain foods each week to enhance adherence to the diet. Subjects assigned to the PA groups will have the opportunity to have one to two practices supervised by week by a team kinesiologist. All participants will have questionnaires to complete at different times during the study. These questionnaires will document several important aspects of the study including participants' health status, eating behaviours, hunger and satiety levels, eating and PA habits, motivation levels and well-being. Participants' diets will be assessed using a validated web 24-hour recall (R24W), which evaluates the food and beverages consumed during the 24 hours prior to the day they complete the questionnaire. This questionnaire will be completed over three randomly selected days on five occasions during the study. The level of PA will be evaluated using an accelerometer that objectively calculates energy expenditure. This device will be worn by participants for consecutive periods of 7 days, 5 times during the study.
Serum triglycerides (TG) concentrations after an oral fat load (35g of fat/m2 of body surface) and other the outcome variables will be measured in each group at baseline and at the end of the 16-week intervention. Specially, the fat load test will occur 2 days after the end of the intervention (114 days), so that the effect of the last exercise training bout has washed out. Cardiometabolic risk factors in the fasting state will be measured at baseline as well as twice at the end of the intervention, i.e. at 16 weeks (112 days) and at 16.3 weeks (114 days). The cardiorespiratory condition of the subjects will be evaluated during an maximal exercise test at the beginning and end of the 16-week intervention (112 days). Body composition will be assessed at the beginning and end of the intervention (112 days) by Dual Energy X-ray Absorptiometry (DEXA). Cardiac structure and function will be measured at the beginning and end (112 days) of the intervention using advanced echocardiographic imaging. Exercise capacity (VO2max) will measured by a modified Bruce protocol at the beginning and end (112 days) of the intervention. Fecal sample will be collected as an optional part of the study at baseline as well as at the end of the intervention (112 days). Deep 16S rDNA metagenomic analysis (in feces) as well as analyses of microbiota metabolites and endogenous bioactive lipid mediators in plasma will be used as surrogates of gut microbiota composition and function.
The primary objective is to compare the impact of each intervention and hence the potential synergistic impact of the MedDiet and PA on postprandial TG concentrations measured 4 hours after consumption of the oral fat load.
Secondary objectives are to compare the impact of each intervention and hence the potential synergistic impact of the MedDiet and PA on fasting concentrations of the following cardiometabolic risk factors: LDL-C, HDL-C, TG, CRP, adiponectin, IL-6, IL-8, TNFA-alpha, SBP, DBP. These comparisons will be performed on two sets of measures at the end of the intervention, i.e. at 16 week (112 days) and 2 days later (16.3 weeks, or 114 days). Secondary objectives also include the comparison of each intervention and hence the potential synergistic impact of the MedDiet and PA on cardiac structure and function and on exercise capacity (VO2max) measured at the end of the 16-week intervention (112 days).
Other pre-specified outcomes include assessment of the associations between changes in study outcomes and in abdominal fat levels as well as exploratory analyses of how the microbiota markers explain the difference between groups in cardiometabolic risk (exploratory objective).
- Conditions
- Cardiometabolic Risk
- Being tested
- Mediterranean diet (MedDiet), Physical activity (PA), Mediterranean diet and physical activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean diet (MedDiet)Behavioural
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.
Physical activity (PA)Behavioural
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.
Mediterranean diet and physical activityBehavioural
The combination group (MedDiet + PA) will receive the combination of both interventions.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean diet (MedDiet) | Experimental | Not described Receives: Behavioral: Mediterranean diet (MedDiet) |
| Physical activity (PA) | Experimental | Not described Receives: Behavioral: Physical activity (PA) |
| Mediterranean diet and physical activity | Experimental | Not described Receives: Behavioral: Mediterranean diet and physical activity |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16.3 week (114 days)
Secondary outcomes (24)
Serum fasting TG concentrations
Fasting serum TG concentrations (mmol/l) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for fasting TG values measured at baseline.
Measured: 16 week (112 days)
Serum fasting TG concentrations
Fasting serum TG concentrations (mmol/l) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for fasting TG values measured at baseline.
Measured: 16.3 week (114 days)
Serum fasting LDL-C concentrations
Fasting serum LDL-C concentrations (mmol/l) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for fasting LDL-C values measured at baseline.
Measured: 16 week (112 days)
Serum fasting LDL-C concentrations
Fasting serum LDL-C concentrations (mmol/l) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for fasting LDL-C values measured at baseline.
Measured: 16.3 week (114 days)
Serum fasting HDL-C concentrations
Fasting serum HDL-C concentrations (mmol/l) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for fasting HDL-C values measured at baseline.
Measured: 16 week (112 days)
Serum fasting HDL-C concentrations
Fasting serum HDL-C concentrations (mmol/l) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for fasting HDL-C values measured at baseline.
Measured: 16.3 week (114 days)
Serum fasting CRP concentrations
Fasting serum CRP concentrations (mg/ l) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for fasting CRP values measured at baseline.
Measured: 16 week (112 days)
Serum fasting CRP concentrations
Fasting serum CRP concentrations (mg/ l) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for fasting CRP values measured at baseline.
Measured: 16.3 week (114 days)
Serum fasting adiponectin concentrations
Fasting serum adiponectin concentrations (mg/l) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for fasting adiponectin values measured at baseline.
Measured: 16 week (112 days)
Serum fasting adiponectin concentrations
Fasting serum adiponectin concentrations (mg/l) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for fasting adiponectin values measured at baseline.
Measured: 16.3 week (114 days)
Serum fasting IL-6 concentrations
Fasting serum IL-6 concentrations (pmol/l) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for fasting IL-6 values measured at baseline.
Measured: 16 week (112 days)
Serum fasting IL-6 concentrations
Fasting serum IL-6 concentrations (pmol/l) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for fasting IL-6 values measured at baseline.
Measured: 16.3 week (114 days)
Serum fasting IL-18 concentrations
Fasting serum IL-18 concentrations (pmol/l) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for fasting IL-18 values measured at baseline.
Measured: 16 week (112 days)
Serum fasting IL-18 concentrations
Fasting serum IL-18 concentrations (pmol/l) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for fasting IL-18 values measured at baseline.
Measured: 16.3 week (114 days)
Serum fasting TNF-alpha concentrations
Fasting serum TNF-alpha concentrations (pmol/l) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for fasting TNF-alpha values measured at baseline.
Measured: 16 week (112 days)
Serum fasting TNF-alpha concentrations
Fasting serum TNF-alpha concentrations (pmol/l) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for fasting TNF-alpha values measured at baseline.
Measured: 16.3 week (114 days)
Systolic blood pressure (SBP)
SBP (mmHg) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for SBP values measured at baseline.
Measured: 16 week (112 days)
Systolic blood pressure (SBP)
SBP (mmHg) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for SBP values measured at baseline.
Measured: 16.3 week (114 days)
Diastolic blood pressure (DBP)
DBP (mmHg) will be measured at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for DBP values measured at baseline.
Measured: 16 week (112 days)
Diastolic blood pressure (DBP)
DBP (mmHg) will be measured 2 days after the end of the 16-wk intervention in all subjects in each group (hence 16.3 weeks, or 114 days). Analyses will be adjusted for DBP values measured at baseline.
Measured: 16.3 week (114 days)
Maximal oxygen consumption (VO2max)
Maximal oxygen consumption, a metric of cardiorespiratory fitness, will be measured by a modified Bruce protocol at the end of the 16-wk intervention in all subjects in each group. Analyses will be adjusted for VO2max values measured at baseline.
Measured: 16 week (112 days)
Left ventricular (LV) global longitudinal strain
LV global longitudinal strain in % will be measured using transthoracic echocardiogram and speckle tracking for systolic and diastolic strain/strain rates. Analyses will be adjusted for LV global longitudinal strain values measured at baseline.
Measured: 16 week (112 days)
Right ventricular (RV) global longitudinal strain
RV global longitudinal strain in % will be measured using transthoracic echocardiogram and speckle tracking for systolic and diastolic strain/strain rates. Analyses will be adjusted for RV global longitudinal strain values measured at baseline.
Measured: 16 week (112 days)
Cardiac chamber volumes
Cardiac chamber volumes (cm3) will be measured using transthoracic echocardiogram with pulse-wave, continuous-wave and tissue Dopplers. Analyses will be adjusted for cardiac chamber volumes measured at baseline.
Measured: 16 week (112 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start22 Oct 2018
- Primary completion24 Apr 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic RiskStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Benoit Lamarche, Laval University
- Investigators
- Benoît Lamarche, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731013
- Sponsor's protocol ID
- INAF-MEx 21628
- Acronym
- MEx
- Status last verified
- Jun 2024
- First submitted
- 22 Oct 2018
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediterranean Diet and Physical Activity: is the Whole Better Than the Sum of Each Part ? Clinical and Mechanistic Perspectives
- ClinicalTrials.gov ID
- NCT03731013
- Acronym / sponsor ID
- MEx / INAF-MEx 21628
- Conditions
- Cardiometabolic Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized study with a 2X2 experimental factorial design. A total of 200 men and women recruited in the Quebec City area via various media will participate in this study. Eligible participants will be randomly assigned to one of four 16-week intervention groups: 1- Mediterranean Diet (MedDiet); 2- Physical Activity (PA); 3- Combination of MedDiet and PA; 4- Control Group. Depending on the group, the intervention involves support for nutritional and PA components at different times, in groups or individually. The subjects assigned to the MedDiet will receive certain foods each week to enhance adherence to the diet. Subjects assigned to the PA groups will have the opportunity to have one to two practices supervised by week by a team kinesiologist. All participants will have questionnaires to complete at different times during the study. These questionnaires will document several important aspects of the study including participants' health status, eating behaviours, hunger and satiety levels, eating and PA habits, motivation levels and well-being. Participants' diets will be assessed using a validated web 24-hour recall (R24W), which evaluates the food and beverages consumed during the 24 hours prior to the day they complete the questionnaire. This questionnaire will be completed over three randomly selected days on five occasions during the study. The level of PA will be evaluated using an accelerometer that objectively calculates energy expenditure. This device will be worn by participants for consecutive periods of 7 days, 5 times during the study.
Serum triglycerides (TG) concentrations after an oral fat load (35g of fat/m2 of body surface) and other the outcome variables will be measured in each group at baseline and at the end of the 16-week intervention. Specially, the fat load test will occur 2 days after the end of the intervention (114 days), so that the effect of the last exercise training bout has washed out. Cardiometabolic risk factors in the fasting state will be measured at baseline as well as twice at the end of the intervention, i.e. at 16 weeks (112 days) and at 16.3 weeks (114 days). The cardiorespiratory condition of the subjects will be evaluated during an maximal exercise test at the beginning and end of the 16-week intervention (112 days). Body composition will be assessed at the beginning and end of the intervention (112 days) by Dual Energy X-ray Absorptiometry (DEXA). Cardiac structure and function will be measured at the beginning and end (112 days) of the intervention using advanced echocardiographic imaging. Exercise capacity (VO2max) will measured by a modified Bruce protocol at the beginning and end (112 days) of the intervention. Fecal sample will be collected as an optional part of the study at baseline as well as at the end of the intervention (112 days). Deep 16S rDNA metagenomic analysis (in feces) as well as analyses of microbiota metabolites and endogenous bioactive lipid mediators in plasma will be used as surrogates of gut microbiota composition and function.
The primary objective is to compare the impact of each intervention and hence the potential synergistic impact of the MedDiet and PA on postprandial TG concentrations measured 4 hours after consumption of the oral fat load.
Secondary objectives are to compare the impact of each intervention and hence the potential synergistic impact of the MedDiet and PA on fasting concentrations of the following cardiometabolic risk factors: LDL-C, HDL-C, TG, CRP, adiponectin, IL-6, IL-8, TNFA-alpha, SBP, DBP. These comparisons will be performed on two sets of measures at the end of the intervention, i.e. at 16 week (112 days) and 2 days later (16.3 weeks, or 114 days). Secondary objectives also include the comparison of each intervention and hence the potential synergistic impact of the MedDiet and PA on cardiac structure and function and on exercise capacity (VO2max) measured at the end of the 16-week intervention (112 days).
Other pre-specified outcomes include assessment of the associations between changes in study outcomes and in abdominal fat levels as well as exploratory analyses of how the microbiota markers explain the difference between groups in cardiometabolic risk (exploratory objective).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Mediterranean diet (MedDiet) |
| 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. | Behavioural | Physical activity (PA) |
| Mediterranean diet and physical activityThe combination group (MedDiet + PA) will receive the combination of both interventions. | Behavioural | Mediterranean diet and physical activity |
Primary outcome
1. Serum 4-hour post-prandial TG concentrations
Time frame: 16.3 week (114 days)
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.
24 secondary outcomes
Serum fasting TG concentrations
Time frame: 16 week (112 days)
Serum fasting TG concentrations
Time frame: 16.3 week (114 days)
Serum fasting LDL-C concentrations
Time frame: 16 week (112 days)
Serum fasting LDL-C concentrations
Time frame: 16.3 week (114 days)
Serum fasting HDL-C concentrations
Time frame: 16 week (112 days)
Serum fasting HDL-C concentrations
Time frame: 16.3 week (114 days)
Serum fasting CRP concentrations
Time frame: 16 week (112 days)
Serum fasting CRP concentrations
Time frame: 16.3 week (114 days)
Serum fasting adiponectin concentrations
Time frame: 16 week (112 days)
Serum fasting adiponectin concentrations
Time frame: 16.3 week (114 days)
Serum fasting IL-6 concentrations
Time frame: 16 week (112 days)
Serum fasting IL-6 concentrations
Time frame: 16.3 week (114 days)
Serum fasting IL-18 concentrations
Time frame: 16 week (112 days)
Serum fasting IL-18 concentrations
Time frame: 16.3 week (114 days)
Serum fasting TNF-alpha concentrations
Time frame: 16 week (112 days)
Serum fasting TNF-alpha concentrations
Time frame: 16.3 week (114 days)
Systolic blood pressure (SBP)
Time frame: 16 week (112 days)
Systolic blood pressure (SBP)
Time frame: 16.3 week (114 days)
Diastolic blood pressure (DBP)
Time frame: 16 week (112 days)
Diastolic blood pressure (DBP)
Time frame: 16.3 week (114 days)
Maximal oxygen consumption (VO2max)
Time frame: 16 week (112 days)
Left ventricular (LV) global longitudinal strain
Time frame: 16 week (112 days)
Right ventricular (RV) global longitudinal strain
Time frame: 16 week (112 days)
Cardiac chamber volumes
Time frame: 16 week (112 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoît Lamarche, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean diet (MedDiet), Physical activity (PA) and Mediterranean diet and physical activity in people with Cardiometabolic Risk, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Serum 4-hour post-prandial TG concentrations (time frame: 16.3 week (114 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.