Institut pour l'avancée des biosciences IAB (U1209)/hôpital couple enfant du CHU Grenoble-Alpes
Grenoble, France
NCT Number: NCT04919434
Main objective The intervention study IRECO aims to (1) modify habits of personal care product use for the participants and (2) evaluate the impact of those modification on urinary concentration for the following compounds: phthalates, phenols and glycol ether.
Secondary objectives:
The secondary objectives of this study aim to evaluate:
1. impact of modification of personal care product on the levels of biomarkers linked to exposure to environmental pollutant other than phthalates phenol and glycol ether (untargeted analysis) and biomarkers related to health (such as inflammatory biomarkers and oxidative stress). 2. hazard perception linked to the exposure to chemical product present in personal care product 3. barriers to change habits allowing to decrease exposure to environmental pollutant on short and long term as well as levers allowing to remove those barriers.
This study is active but is not currently recruiting participants.
Notify Me18 year–30 year
Female
Interventional
Not applicable
Grenoble, France
Many chemical compounds are allowed as ingredients in personal care product. Among those substances, phenols, phthalates and some glycol ether are widely detected in personal care product. Few epidemiological studies suggested association between the use of personal care product and higher urinary concentration of parabens, phthalates, bisphenol A and triclosan. In France, studies in general population also show those associations and suggested higher urinary concentration of some glycol ethers in users of cosmetics, (make up, nail polish, nail polish remover), deodorant, and care product (cream, lotion etc.) The intervention study IRECO (Intervention to Reduce Exposure to environmental Contaminant) aims to study the impact of personal care product on exposure levels of compounds from phenol, phthalates and glycol ether. This project will allow to better characterize sources of exposure of those chemical compounds for which deleterious effect on health is suspected. The results of this study will be informative and will allow to bring concrete solutions to the general population who wish to reduce their exposure. The study will also allow to help decision maker in trying to limit exposure to chemical compounds such as phthalates and phenols in daily consumption product. To date, these type of intervention studies were conducted in the USA and no study have been done in France so far where regulation and consumption habits differs from the USA.
The two main objectives of the intervention study IRECO are: (1) modify habits of personal care product use for the participants and (2) evaluate the impact of those modification on urinary concentration for the following compounds: phthalates, phenols and glycol ether.
To meet those objectives, 100 women with the following inclusion criteria will be included in the study : (1) aged between 18 and 30 years, (2) accept to not use personal care product or use only the alternative personal care product distributed by the research team for 5 days, (3) to not have any known allergies to ingredients in the alternative personal care product, (4) to benefit from the French health assurance ; (5) live in the area of Grenoble (France) (6) speak French fluently, (7) have a freezer to store the urine collected.
The study follow-up will include 12 days of measure divided in three phases :
2 months after the intervention a fieldworker will go the volunteer's home to conduct a semi-structured interview on her changes in the use of personal care product following her participation into the intervention study IRECO.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
During 5 days, women included in the study will have to only use personal care product distributed by the research team.
Time frame: follow-up 1 week
Urinary concentration of phthalates, phenols and glycol ether will be measured in urine sample. Urinary concentration will be measured in the three phases of the study : before intervention (phase 1), during intervention (phase 2) and after intervention (phase 3). The level of urinary concentration will be compared between each phase : phase 1 versus phase 2 and phase 2 versus phase 3.
Time frame: follow-up 1 week
An untargeted approach will be conducted where chemical pollutants other than phthalates, phenols and glycol ether will be measured in urines. Urinary concentration of pollutants will be measured in the three phases of the study : before intervention (phase 1), during intervention (phase 2) and after intervention (phase 3). The level of urinary concentration will be compared between : (a) phase 1 and phase 2 and (b) phase 2 and phase 3.
Time frame: during the follow-up week.
A qualitative analysis will be conducted with the data collected during the sociodemographic interview. The analysis will describe the hazard perception of the volunteers linked to the exposure to chemical products present in personal care product.
Time frame: during the follow-up week and 2 months after the intervention
A qualitative analysis will be conducted with the data collected during the sociodemographic interview. The analysis will describe the barriers to change habits allowing to decrease exposure to environmental pollutant on short and long term as well as levers allowing to remove those barriers.
Institut National de la Santé Et de la Recherche Médicale, France
Other Gov
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