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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-A01126-33 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| ITERG | INDUSTRY |
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We propose to measure the LCPUFA human milk (linolenic acid, linoleic acid, docosahexaenoic acid, arachidonic acid) according to fatty acids nature and quantities consumed by lactating women
n-3 and n-6 long chain polyunsaturated fatty acids (LCPUFA) are essential particularly to neurodevelopment of newborn infants. Many variations in essential PUFA and LCPUFA content of human milk are observed according to countries and dietary habits of the mothers.
Maternal diet supplementation of LCPUFA of lactating women may increase LCPUFA human milk according to consensus recommendations.
This clinical trial is performed to evaluate the effect of different of consumption of n-3 fatty acids (linolenic acid) in different forms (oils or margarine) in the human milk composition.
Each diet will last 30 days. During the first period of 15 days, the mothers will receive mediterranean diet based on olive oil. Then, lactating women will be randomised into four groups : one group will receive olive oil (standard group), one group supplemented in rapeseed oil, one group with n-3 margarine and one group with diet associating rapeseed oil and n-3 margarine.Human milk will be collected during the first breastfeeding of the day (10 ml) at three times : Days 0 corresponding to the usual diet , at day 15 after the Mediterranean diet and at day 30, after the study diet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rapeseed oil | Experimental |
| |
| n-3 margarine and rapeseed oil | Experimental |
| |
| n-3 margarine | Experimental |
| |
| Olive oil | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nutritional intervention | Dietary Supplement | Each diet will last 30 days. During the first period of 15 days, the mothers will receive mediterranean diet based on olive oil. Then, lactating women will receive 30gr/day rapeseed oil. Human milk will be collected during the first breastfeeding of the day (10 ml) at three times : Days 0 corresponding to the usual diet , at day 15 after the Mediterranean diet and at day 30, after the study diet. |
| Measure | Description | Time Frame |
|---|---|---|
| Acide linolenic 18 :3 n-3 analysis measured at day 30, compared to day 15 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of linolenic acid and linoleic acid ratio | 30 days | |
| Analysis of arachidonic acid, docosahexanoic acid and their ratio | 30 days | |
| Comparison of fatty acid composition of human milk before and after supplementation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul PEREZ, MD, PhD | University Hospital Bordeaux (France) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lactarium Hôpital Pellegrin Enfants CHU Bordeaux | Bordeaux | 33076 | France | |||
| Lactarium CHU La Croix Rousse Lyon Néonatologie et Réanimation Néonatale |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11137568 | Background | Lauritzen L, Hansen HS, Jorgensen MH, Michaelsen KF. The essentiality of long chain n-3 fatty acids in relation to development and function of the brain and retina. Prog Lipid Res. 2001 Jan-Mar;40(1-2):1-94. doi: 10.1016/s0163-7827(00)00017-5. No abstract available. | |
| 9029636 | Background | Sauerwald TU, Hachey DL, Jensen CL, Chen H, Anderson RE, Heird WC. Intermediates in endogenous synthesis of C22:6 omega 3 and C20:4 omega 6 by term and preterm infants. Pediatr Res. 1997 Feb;41(2):183-7. doi: 10.1203/00006450-199702000-00005. |
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|
| nutritional intervention | Dietary Supplement | Each diet will last 30 days. During the first period of 15 days, the mothers will receive mediterranean diet based on olive oil. Then, lactating women will receive diet associating 30gr/day of rapeseed oil and n-3 margarine. Human milk will be collected during the first breastfeeding of the day (10 ml) at three times : Days 0 corresponding to the usual diet , at day 15 after the Mediterranean diet and at day 30, after the study diet. |
|
| nutritional intervention | Dietary Supplement | Each diet will last 30 days. During the first period of 15 days, the mothers will receive mediterranean diet based on olive oil. Then, lactating women will receive with 30gr/day n-3 margarine. Human milk will be collected during the first breastfeeding of the day (10 ml) at three times : Days 0 corresponding to the usual diet , at day 15 after the Mediterranean diet and at day 30, after the study diet. |
|
| nutritional intervention | Dietary Supplement | Each diet will last 30 days. During the first period of 15 days, the mothers will receive mediterranean diet based on olive oil. Then, lactating women receive 30gr/day olive oil (standard group. Human milk will be collected during the first breastfeeding of the day (10 ml) at three times : Days 0 corresponding to the usual diet , at day 15 after the Mediterranean diet and at day 30, after the study diet. |
|
| 30 days |
| Analysis of trans fatty acids according diets | 30 days |
| Lyon |
| 69004 |
| France |
| Lactarium CHU Montpellier Pédiatrie 2 | Montpellier | 34925 | France |
| Lactarium Institut de Puériculture de Paris et de Périnatalogie | Paris | 75014 | France |
| 10695931 | Background | Cunnane SC, Francescutti V, Brenna JT, Crawford MA. Breast-fed infants achieve a higher rate of brain and whole body docosahexaenoate accumulation than formula-fed infants not consuming dietary docosahexaenoate. Lipids. 2000 Jan;35(1):105-11. doi: 10.1007/s11745-000-0501-6. |
| 11598600 | Background | Innis SM, Gilley J, Werker J. Are human milk long-chain polyunsaturated fatty acids related to visual and neural development in breast-fed term infants? J Pediatr. 2001 Oct;139(4):532-8. doi: 10.1067/mpd.2001.118429. |
| 11345178 | Background | Jorgensen MH, Hernell O, Hughes E, Michaelsen KF. Is there a relation between docosahexaenoic acid concentration in mothers' milk and visual development in term infants? J Pediatr Gastroenterol Nutr. 2001 Mar;32(3):293-6. doi: 10.1097/00005176-200103000-00011. |
| 18253974 | Background | Simmer K, Patole SK, Rao SC. Long-chain polyunsaturated fatty acid supplementation in infants born at term. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD000376. doi: 10.1002/14651858.CD000376.pub2. |
| 14597910 | Background | Uauy R, Hoffman DR, Mena P, Llanos A, Birch EE. Term infant studies of DHA and ARA supplementation on neurodevelopment: results of randomized controlled trials. J Pediatr. 2003 Oct;143(4 Suppl):S17-25. doi: 10.1067/s0022-3476(03)00398-6. |
| 12838196 | Background | Hoffman DR, Birch EE, Castaneda YS, Fawcett SL, Wheaton DH, Birch DG, Uauy R. Visual function in breast-fed term infants weaned to formula with or without long-chain polyunsaturates at 4 to 6 months: a randomized clinical trial. J Pediatr. 2003 Jun;142(6):669-77. doi: 10.1067/mpd.2003.213. |
| 10742608 | Background | SanGiovanni JP, Berkey CS, Dwyer JT, Colditz GA. Dietary essential fatty acids, long-chain polyunsaturated fatty acids, and visual resolution acuity in healthy fullterm infants: a systematic review. Early Hum Dev. 2000 Mar;57(3):165-88. doi: 10.1016/s0378-3782(00)00050-5. |
| 12032520 | Background | Innis SM, Adamkin DH, Hall RT, Kalhan SC, Lair C, Lim M, Stevens DC, Twist PF, Diersen-Schade DA, Harris CL, Merkel KL, Hansen JW. Docosahexaenoic acid and arachidonic acid enhance growth with no adverse effects in preterm infants fed formula. J Pediatr. 2002 May;140(5):547-54. doi: 10.1067/mpd.2002.123282. |
| 16002810 | Background | Jensen CL, Voigt RG, Prager TC, Zou YL, Fraley JK, Rozelle JC, Turcich MR, Llorente AM, Anderson RE, Heird WC. Effects of maternal docosahexaenoic acid intake on visual function and neurodevelopment in breastfed term infants. Am J Clin Nutr. 2005 Jul;82(1):125-32. doi: 10.1093/ajcn.82.1.125. |
| 12509593 | Background | Helland IB, Smith L, Saarem K, Saugstad OD, Drevon CA. Maternal supplementation with very-long-chain n-3 fatty acids during pregnancy and lactation augments children's IQ at 4 years of age. Pediatrics. 2003 Jan;111(1):e39-44. doi: 10.1542/peds.111.1.e39. |
| 10974044 | Background | Fidler N, Sauerwald T, Pohl A, Demmelmair H, Koletzko B. Docosahexaenoic acid transfer into human milk after dietary supplementation: a randomized clinical trial. J Lipid Res. 2000 Sep;41(9):1376-83. |
| 10755457 | Background | Birch EE, Garfield S, Hoffman DR, Uauy R, Birch DG. A randomized controlled trial of early dietary supply of long-chain polyunsaturated fatty acids and mental development in term infants. Dev Med Child Neurol. 2000 Mar;42(3):174-81. doi: 10.1017/s0012162200000311. |
| 17637092 | Background | Innis SM. Human milk: maternal dietary lipids and infant development. Proc Nutr Soc. 2007 Aug;66(3):397-404. doi: 10.1017/S0029665107005666. |
| 18184094 | Background | Koletzko B, Lien E, Agostoni C, Bohles H, Campoy C, Cetin I, Decsi T, Dudenhausen JW, Dupont C, Forsyth S, Hoesli I, Holzgreve W, Lapillonne A, Putet G, Secher NJ, Symonds M, Szajewska H, Willatts P, Uauy R; World Association of Perinatal Medicine Dietary Guidelines Working Group. The roles of long-chain polyunsaturated fatty acids in pregnancy, lactation and infancy: review of current knowledge and consensus recommendations. J Perinat Med. 2008;36(1):5-14. doi: 10.1515/JPM.2008.001. |
| 17152922 | Background | Yuhas R, Pramuk K, Lien EL. Human milk fatty acid composition from nine countries varies most in DHA. Lipids. 2006 Sep;41(9):851-8. doi: 10.1007/s11745-006-5040-7. |
| 9306083 | Background | Gibson RA, Neumann MA, Makrides M. Effect of increasing breast milk docosahexaenoic acid on plasma and erythrocyte phospholipid fatty acids and neural indices of exclusively breast fed infants. Eur J Clin Nutr. 1997 Sep;51(9):578-84. doi: 10.1038/sj.ejcn.1600446. |
| 11248877 | Background | Billeaud C, Bougle D, Sarda P, Combe N, Mazette S, Babin F, Entressangles B, Descomps B, Nouvelot A, Mendy F. Effects of preterm infant formula supplementation with alpha-linolenic acid with a linoleate/alpha-linolenate ratio of 6: a multicentric study. Eur J Clin Nutr. 1997 Aug;51(8):520-6. doi: 10.1038/sj.ejcn.1600436. |
| 9459379 | Background | Francois CA, Connor SL, Wander RC, Connor WE. Acute effects of dietary fatty acids on the fatty acids of human milk. Am J Clin Nutr. 1998 Feb;67(2):301-8. doi: 10.1093/ajcn/67.2.301. |
| 20800325 | Background | Molto-Puigmarti C, Castellote AI, Carbonell-Estrany X, Lopez-Sabater MC. Differences in fat content and fatty acid proportions among colostrum, transitional, and mature milk from women delivering very preterm, preterm, and term infants. Clin Nutr. 2011 Feb;30(1):116-23. doi: 10.1016/j.clnu.2010.07.013. Epub 2010 Aug 25. |
| 28418808 | Result | Mazurier E, Rigourd V, Perez P, Buffin R, Couedelo L, Vaysse C, Belcadi W, Sitta R, Nacka F, Lamireau D, Cambonie G, Picaud JC, Billeaud C. Effects of Maternal Supplementation With Omega-3 Precursors on Human Milk Composition. J Hum Lact. 2017 May;33(2):319-328. doi: 10.1177/0890334417691946. Epub 2017 Mar 23. |