
Last update : 09/05/2017 | Version : 2 | ID : 4789
| General | |
| Identification | |
| Detailed name | Interventional Longitudinal Study on The Effects of Long-Chain Omega-3 Docosahexaenoic Acid on Platelet Function and Redox Status |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CCPPRB LYON A (03/11/2004). |
| General Aspects | |
| Medical area |
Hematology |
| Health determinants |
Nutrition |
| Keywords | omega-3 fatty acids, docosahexaenoic acid, platelet function, redox status, healthy males, intake |
| Scientific investigator(s) (Contact) | |
| Name of the director | Vidal |
| Surname | Hubert |
| Address | Faculté de Médecine Lyon-Sud 165 Chemin du Grand Revoyet BP 12 69921 OULLINS Cedex-France |
| Phone | +33 (0)4 26 23 59 18 |
| hubert.vidal@univ-lyon1.fr | |
| Unit | U1060 |
| Organization | INSERM - Institut National de la Santé et de la Recherche |
| Name of the director | Véricel |
| Surname | Evelyne |
| Address | IMBL, Bât Louis Pasteur, INSA, 20 ave A. Einstein, 69621 VILLEURBANNE Cedex-France |
| Phone | +33 (0)4 72 43 84 79 |
| evelyne.vericel@insa-lyon.fr | |
| Unit | U1060 |
| Organization | INSERM - Institut National de la Santé et de la Recherche |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | INSERM, grant from the Lipids and Nutrition Group (Neuilly-sur-Seine, France), grant from the French Ministry of Research and Education. Funding from the Lipids and Nutrition Group. |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | INSERM - Institut National de la Santé et de la Recherche Médicale |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | --- |
| Database objective | |
| Main objective | To determine the effects of increased intake of docosahexaenoic acid on platelet function and oxidative stress in a group of healthy male volunteers. |
| Inclusion criteria | Healthy male volunteers. |
| Population type | |
| Age |
Adulthood (45 to 64 years) |
| Population covered |
General population |
| Gender |
Male |
| Geography area |
Local |
| French regions covered by the database |
Auvergne Rhône-Alpes |
| Detail of the geography area | Lyon. |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2005 |
| Date of last collection (YYYY or MM/YYYY) | 2007 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 12 (2014) |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Biological data |
| Clinical data (detail) |
Medical registration |
| Details of collected clinical data | ---- |
| Biological data (detail) | Blood lipid assay, study of platelet function and redox status parameters. |
| Presence of a biobank |
No |
| Health parameters studied |
Others |
| Other (detail) | --- |
| Procedures | |
| Data collection method | Blood and urine samples collected before and after each supplementation dose and 8 weeks after arrest of supplementation. Supplementation: daily intake of successive doses: increments of 200, 400, 800, and 1600 mg DHA (Decola, Maldegem, Belgium) for 2 weeks for each dose without interruption. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 8 weeks after treatment. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Hal-Effets-chaine-omega3 |
| Description | List of publications in HAL |
| Link to the document | http://tinyurl.com/Pubmed-Effets-chaine-omega3 |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Publications. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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