NCT06380218

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 23, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

1.6 years

First QC Date

March 22, 2024

Last Update Submit

April 18, 2024

Conditions

Healthy Volunteers

Keywords

Nutritional and physical activity programPreventionCardiovascular healthQuality of life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (22)

  • Change from baseline on life behaviours at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"

    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"

    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"

    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"

    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"

    At 3 months after the coaching session

  • +17 more secondary outcomes

Study Arms (1)

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

Behavioral: Nutrional and physical activity program

Interventions

Nutrional and physical activity programBEHAVIORAL

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

Nutrional and physical activity program

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \> 25kg/m² and/or with a waist circumference \> 88 cm
  • Regularly consuming butter and/or "standard" margarine rich in saturated fatty acids

You may not qualify if:

  • Regularly consuming "healthy" margarine enriched with omega 3 (Primevere, St Hubert ω3 ...) or with phytosterols (Pro-active)
  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NutrInvest - Institut Pasteur de Lille

Lille, Nord, 59019, France

RECRUITING

Study Officials

  • Jean-Michel Lecerf, MD

    Institut Pasteur de Lille - NutrInvest

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Coralie BERTHIER, PhD

CONTACT

0320877333coralie.berthier@pasteur-lille.fr

Jean-Michel LECERF, MD

CONTACT

0320877771jean-michel.lecerf@pasteur-lille.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Invesigator

Study Record Dates

First Submitted

March 22, 2024

First Posted

April 23, 2024

Study Start

July 11, 2023

Primary Completion

March 1, 2025

Study Completion

August 1, 2025

Last Updated

April 23, 2024

Record last verified: 2024-04

Locations

FR(1)