Healthy Volunteers Clinical Trial
— SAFEOfficial title:
Evaluation of Nutritional Prevention Program for Women's Cardiovascular Health on Quality of Life (SAFE)
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.
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | August 1, 2025 |
| Est. primary completion date | March 1, 2025 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 40 Years to 65 Years |
| Eligibility | 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 ?3 ...) 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.) |
| Country | Name | City | State |
|---|---|---|---|
| France | NutrInvest - Institut Pasteur de Lille | Lille | Nord |
| Lead Sponsor | Collaborator |
|---|---|
| Institut Pasteur de Lille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | At 3 months after the coaching session | |
| Secondary | 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 | At 3 months after the coaching session | |
| Secondary | 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) | At 3 months after the coaching session | |
| Secondary | Change from baseline on stress management at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" | Cohen Questionnaire | At 3 months after the coaching session | |
| Secondary | 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 | At 3 months after the coaching session | |
| Secondary | 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 | At 3 months after the coaching session | |
| Secondary | 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) | At 3 months after the coaching session | |
| Secondary | 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 | At 3 months after the coaching session | |
| Secondary | 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) | At 3 months after the coaching session | |
| Secondary | 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 |
At 3 months after the coaching session | |
| Secondary | 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 |
At 3 months after the coaching session | |
| Secondary | 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) |
At 3 months after the coaching session | |
| Secondary | 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 |
At 3 months after the coaching session | |
| Secondary | 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 |
At 3 months after the coaching session | |
| Secondary | 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 |
At 3 months after the coaching session | |
| Secondary | 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 ?3 and ratio ?6/?3 | At 3 months after the coaching session | |
| Secondary | 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 | At 3 months after the coaching session | |
| Secondary | 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 | At 3 months after the coaching session | |
| Secondary | 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 | At 3 months after the coaching session | |
| Secondary | Change from baseline on waist circumference at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" | Waist circumference (cm) | At 3 months after the coaching session | |
| Secondary | 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 | At 3 months after the coaching session | |
| Secondary | 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 | At 3 months after the coaching session | |
| Secondary | Satisfaction of Primevere products | Measured by comprehension and utility of Primevere tools questionnaire and perception of Primevere Margarine | On the last coaching session - 10 weeks |
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