Healthy VolunteersSAFENCT06380218
Evaluation of Nutritional Prevention Program for Women's Cardiovascular Health on Quality of Life (SAFE)
A study testing Nutrional and physical activity program in people with Healthy Volunteers, run by Institut Pasteur de Lille at 1 site in France.
Trial summary
The objective is to evaluate the effect of a nutritional prevention program associated with the consumption of "Primevère margarine" on the quality of life of women at risk of cardiovascular disease after 10 group coaching sessions in nutrition and physical activity. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Nutrional and physical activity program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jul 2023to 1 Aug 2025
- 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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI > 25kg/m² and/or with a waist circumference > 88 cm
- Regularly consuming butter and/or "standard" margarine rich in saturated fatty acids
Who cannot join
- Regularly consuming "healthy" margarine enriched with omega 3 (Primevere, St Hubert ω3 ...) or with phytosterols (Pro-active)
- Consuming omega-3 rich food supplements within 3 months of inclusion
- Treated with lipid-lowering agents (statins), antidiabetic or antihypertensive drugs for less than 3 months
- Suffering of eating disorders
- Presenting a medical contraindication to the practice of physical activity
- Having previously participated in a similar prevention program
- Suffering from serious chronic diseases (cancer, serious cardiovascular history, etc.)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
NutrInvest - Institut Pasteur de Lille
Lille, Nord, 59019
Coralie Berthier, PhD, 0320877333 ext. 0033, coralie.berthier@pasteur-lille.fr
Bérengère Legendre, 0320877346 ext. 0033, berengere.legendre@pasteur-lille.fr
About this study
The objective is to evaluate the effect of a nutritional prevention program associated with the consumption of "Primevère margarine" on the quality of life of women at risk of cardiovascular disease after 10 group coaching sessions in nutrition and physical activity.
Read the detailed description
The objective is to evaluate the effect of a nutritional prevention program associated with the consumption of "Primevère margarine" on the quality of life of women aged 40 to 65 with cardiovascular risk 3 months after 10 group coaching sessions.
The nutritional prevention program includes tools and 10 collective workshops to change the life behaviours (eating habits and physical activity) by assessing :
- Food balance and diversity
- Eating behaviour and representations
- Level of knowledge in nutrition
- Level of physical activity and physical inactivity
- Physical abilities: strength, balance, flexibility, cardio respiratory endurance, recovery capacity
- Behavioural barriers and educational levers to improve women's cardiovascular health
- Conditions
- Healthy Volunteers
- Being tested
- Nutrional and physical activity program
- Keywords
- Nutritional and physical activity program, Prevention, Cardiovascular health, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrional and physical activity programBehavioural
Nutritional prevention and physical activity workshops associated with a substitution of saturated and/or trans fatty acids by cis-unsaturated acids via the consumption of Primevère margarine to influence lifestyle habits, quality of life and improvement of the lipid profile of women with cardiovascular risk
| Study group | Role | What they receive |
|---|---|---|
| Nutrional and physical activity program | Experimental | 10 collective combined workshops of nutrition and physical activity = 1 per week during 10 weeks associated to margarine consumption Receives: Behavioral: Nutrional and physical activity program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on quality of life of women with cardiovascular risk at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Quality of Life Questionnaire Short Form-36 validated by World Health Organization (WHO)
Measured: At 3 months after the coaching session
Secondary outcomes (22)
Change from baseline on life behaviours at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Lifestyle Questionnaire : consumption of alcohol and tobacco and quality of sleeping
Measured: At 3 months after the coaching session
Change from baseline on well-being at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Visual analogue scales on changes in well-being ranging from 10 (best) to 0 (worst)
Measured: At 3 months after the coaching session
Change from baseline on stress management at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Cohen Questionnaire
Measured: At 3 months after the coaching session
Change from baseline on food behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Balance and dietary diversity questionnaire proposed by the Institut Pasteur de Lille
Measured: At 3 months after the coaching session
Change from baseline on food behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Behavioural questionnaire and food representation proposed by the Institut Pasteur de Lille
Measured: At 3 months after the coaching session
Change from baseline on food and physical activity knowledge at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Food knowledge Questionnaire (10 points) Physical Activity knowledge Questionnaire (10 points)
Measured: At 3 months after the coaching session
Change from baseline on motivation to change behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Prochaska Scale: Motivation to Change raging from "I don't want to" to "I will continue to do so" Identifying Barriers and Levers for Behaviour Change Related to Physical Activity Practice and food
Measured: At 3 months after the coaching session
Change from baseline on physical behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Ricci \& Gagnon questionnaire (level of physical activity and sedentary lifestyle)
Measured: At 3 months after the coaching session
Change from baseline on recovery capacity at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
The using test is :
- Ruffier Dickson test (recovery capacity) - to calculate an index of the heart's ability to adapt to physical activity with the heart rate measurement
This index is measured like that :
< or = 0 : excellent 0 to 2 : very good 2 to 4 : good 4 to 6 : average 6 to 8 : weak 8 to 10 : very weak > 10 : poor adaptation
Measured: At 3 months after the coaching session
Change from baseline on static balance at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
The using test is :
- Unipodal balance (static balance) Measured in seconds
Measured: At 3 months after the coaching session
Change from baseline on flexibility at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
The using test is :
- Flexible trunk and posterior chain of lower limbs (flexibility) Measured by index ranging from 5 (the palms of the hands touch the ground) to 1 (the fingertips reach the lower shins)
Measured: At 3 months after the coaching session
Change from baseline on handgrip strengh at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
The using test is :
- Grip force (handgrip strength) Measured in kilograms
Measured: At 3 months after the coaching session
Change from baseline on lower limb strengh at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
The using test is :
- Sitting/standing on chair (lower limb strength) Measured in seconds
Measured: At 3 months after the coaching session
Change from baseline on endurance at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
The using test is :
- 6 minutes walk test (endurance) Measured in meters
Measured: At 3 months after the coaching session
Change from baseline on lipids metabolism at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Blood samples will be collected to analyse: Total cholesterol, HDL, LDL, triglycerides and erythrocyte rate ω3 and ratio ω6/ω3
Measured: At 3 months after the coaching session
Change from baseline on glucose metabolism at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Blood samples will be collected to analyse fasting blood glucose
Measured: At 3 months after the coaching session
Change from baseline on cardiovascular risk at 3 months after a nutritional prevention program
Cardiovascular risk will be collected Cardiovascular Risk Assessment SCORE. The major variables are sexe, age, smoking status or not, blood pressure and total cholesterol
Measured: At 3 months after the coaching session
Change from baseline on BMI at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Height, (m) weight (kg) to calculate BMI
Measured: At 3 months after the coaching session
Change from baseline on waist circumference at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Waist circumference (cm)
Measured: At 3 months after the coaching session
Change from baseline on body composition at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Body composition by impedance measurement: % fat mass, % lean mass
Measured: At 3 months after the coaching session
Change from baseline on systolic and diastolic blood pressure at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Systolic and diastolic blood pressure to calculate blood pressure
Measured: At 3 months after the coaching session
Satisfaction of Primevere products
Measured by comprehension and utility of Primevere tools questionnaire and perception of Primevere Margarine
Measured: On the last coaching session - 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start11 Jul 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur de Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Michel Lecerf, Institut Pasteur de Lille
- Investigators
- Jean-Michel Lecerf, MD, Principal investigator, Institut Pasteur de Lille - NutrInvest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380218
- Sponsor's protocol ID
- 2023-A00249-36
- Acronym
- SAFE
- Status last verified
- Apr 2024
- First submitted
- 22 Mar 2024
- Last updated
- 23 Apr 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 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nutritional Prevention Program for Women's Cardiovascular Health on Quality of Life (SAFE)
- ClinicalTrials.gov ID
- NCT06380218
- Acronym / sponsor ID
- SAFE / 2023-A00249-36
- Conditions
- Healthy Volunteers
- Keywords
- Nutritional and physical activity program, Prevention, Cardiovascular health, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institut Pasteur de LilleUniversity, hospital or other
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 23 Apr 2024 (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.
The objective is to evaluate the effect of a nutritional prevention program associated with the consumption of "Primevère margarine" on the quality of life of women at risk of cardiovascular disease after 10 group coaching sessions in nutrition and physical activity.
Detailed description
The objective is to evaluate the effect of a nutritional prevention program associated with the consumption of "Primevère margarine" on the quality of life of women aged 40 to 65 with cardiovascular risk 3 months after 10 group coaching sessions.
The nutritional prevention program includes tools and 10 collective workshops to change the life behaviours (eating habits and physical activity) by assessing :
- Food balance and diversity
- Eating behaviour and representations
- Level of knowledge in nutrition
- Level of physical activity and physical inactivity
- Physical abilities: strength, balance, flexibility, cardio respiratory endurance, recovery capacity
- Behavioural barriers and educational levers to improve women's cardiovascular health
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutrional and physical activity program | Experimental | Behavioral: Nutrional and physical activity program10 collective combined workshops of nutrition and physical activity = 1 per week during 10 weeks associated to margarine consumption |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI > 25kg/m² and/or with a waist circumference > 88 cm
- Regularly consuming butter and/or "standard" margarine rich in saturated fatty acids
Key exclusion criteria (7 listed)
- Regularly consuming "healthy" margarine enriched with omega 3 (Primevere, St Hubert ω3 ...) or with phytosterols (Pro-active)
- Consuming omega-3 rich food supplements within 3 months of inclusion
- Treated with lipid-lowering agents (statins), antidiabetic or antihypertensive drugs for less than 3 months
- Suffering of eating disorders
- Presenting a medical contraindication to the practice of physical activity
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 |
|---|---|---|
| Nutrional and physical activity programNutritional prevention and physical activity workshops associated with a substitution of saturated and/or trans fatty acids by cis-unsaturated acids via the consumption of Primevère margarine to influence lifestyle habits, quality of life and improvement of the lipid profile of women with cardiovascular risk | Behavioural | Nutrional and physical activity program |
Primary outcome
Change from baseline on quality of life of women with cardiovascular risk at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Time frame: At 3 months after the coaching session
Quality of Life Questionnaire Short Form-36 validated by World Health Organization (WHO)
22 secondary outcomes
Change from baseline on life behaviours at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Time frame: At 3 months after the coaching session
Change from baseline on well-being at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Time frame: At 3 months after the coaching session
Change from baseline on stress management at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Time frame: At 3 months after the coaching session
Change from baseline on food behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Time frame: At 3 months after the coaching session
Change from baseline on food behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Time frame: At 3 months after the coaching session
Change from baseline on food and physical activity knowledge at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Time frame: At 3 months after the coaching session
Change from baseline on motivation to change behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Time frame: At 3 months after the coaching session
Change from baseline on physical behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Time frame: At 3 months after the coaching session
Change from baseline on recovery capacity at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Time frame: At 3 months after the coaching session
Change from baseline on static balance at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Time frame: At 3 months after the coaching session
Change from baseline on flexibility at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Time frame: At 3 months after the coaching session
Change from baseline on handgrip strengh at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Time frame: At 3 months after the coaching session
Change from baseline on lower limb strengh at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Time frame: At 3 months after the coaching session
Change from baseline on endurance at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Time frame: At 3 months after the coaching session
Change from baseline on lipids metabolism at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Time frame: At 3 months after the coaching session
Change from baseline on glucose metabolism at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Time frame: At 3 months after the coaching session
Change from baseline on cardiovascular risk at 3 months after a nutritional prevention program
Time frame: At 3 months after the coaching session
Change from baseline on BMI at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Time frame: At 3 months after the coaching session
Change from baseline on waist circumference at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Time frame: At 3 months after the coaching session
Change from baseline on body composition at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Time frame: At 3 months after the coaching session
Change from baseline on systolic and diastolic blood pressure at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
Time frame: At 3 months after the coaching session
Satisfaction of Primevere products
Time frame: On the last coaching session - 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 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.
Jean-Michel Lecerf, MD principal investigator
Institut Pasteur de Lille - NutrInvest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrional and physical activity program in people with Healthy Volunteers, run by Institut Pasteur de Lille at 1 site in France.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Apr 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Coralie BERTHIER, PhD (0320877333 ext. 0033, coralie.berthier@pasteur-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline on quality of life of women with cardiovascular risk at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" (time frame: At 3 months after the coaching session). 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 23 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.