Nutritional program to improve cardiovascular health in women
Evaluation of Nutritional Prevention Program for Women's Cardiovascular Health on Quality of Life (SAFE)
This study tests if a nutrition program using 'Primevère margarine' can help women aged 40 to 65 at risk for heart disease improve their health and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | Female |
| Sponsor | Institut Pasteur de Lille Academic / other |
| Locations | 1 site (Lille, Nord) |
| Trial ID | NCT06380218 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of a nutritional prevention program that includes the consumption of 'Primevère margarine' on the quality of life of women aged 40 to 65 who are at risk for cardiovascular disease. Participants will attend 10 group coaching sessions focused on nutrition and physical activity, aiming to improve their eating habits and physical fitness. The program assesses various factors such as food balance, eating behavior, nutritional knowledge, and physical abilities to promote healthier lifestyles and enhance cardiovascular health.
Who should consider this trial
Good fit: Ideal candidates are women aged 40 to 65 with a BMI over 25 kg/m² or a waist circumference greater than 88 cm who regularly consume butter or standard margarine.
Not a fit: Patients who consume healthy margarine enriched with omega-3 or have serious chronic diseases may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly improve the quality of life and cardiovascular health of women at risk.
How similar studies have performed: Other studies have shown success with similar nutritional and lifestyle intervention approaches for improving cardiovascular health, indicating potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * BMI \> 25kg/m² and/or with a waist circumference \> 88 cm * Regularly consuming butter and/or "standard" margarine rich in saturated fatty acids Exclusion Criteria: * 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.)
Where this trial is running
Lille, Nord
- NutrInvest - Institut Pasteur de Lille — Lille, Nord, France (Recruiting)
Study contacts
- Principal investigator: Jean-Michel Lecerf, MD — Institut Pasteur de Lille - NutrInvest
- Study coordinator: Coralie BERTHIER, PhD
- Email: coralie.berthier@pasteur-lille.fr
- Phone: 0320877333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.