| January 31, 2011 |
| May 17, 2013 |
| September 2011 |
| September 2014 (final data collection date for primary outcome measure) |
| Acide linolenic 18 :3 n-3 analysis measured at day 30, compared to day 15 [ Time Frame: 30 days ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT01288313 on ClinicalTrials.gov Archive Site |
- Analysis of linolenic acid and linoleic acid ratio [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Analysis of arachidonic acid, docosahexanoic acid and their ratio [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Comparison of fatty acid composition of human milk before and after supplementation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Analysis of trans fatty acids according diets [ Time Frame: 30 days ] [ Designated as safety issue: No ]
|
| Same as current |
| Not Provided |
| Not Provided |
| |
| Effect of n-3 Polyunsaturated Fatty Acids Supplementation on Human Milk Composition of Lactating Women |
| Effect of N-3 Polyunsaturated Fatty Acids Supplementation on the Human Milk Composition of Lactating Women: Nutritional Intervention With Rapeseed Oil and n-3 Margarine Compared to Standard Olive Oil |
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. |
| Interventional |
| Not Provided |
Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Nursing Women |
- Dietary Supplement: nutritional intervention
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.
- Dietary Supplement: nutritional intervention
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.
- Dietary Supplement: nutritional intervention
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.
- Dietary Supplement: nutritional intervention
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.
|
- Experimental: rapeseed oil
Intervention: Dietary Supplement: nutritional intervention
- Experimental: n-3 margarine and rapeseed oil
Intervention: Dietary Supplement: nutritional intervention
- Experimental: n-3 margarine
Intervention: Dietary Supplement: nutritional intervention
- Active Comparator: Olive oil
Intervention: Dietary Supplement: nutritional intervention
|
- Lauritzen L, Hansen HS, Jørgensen 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. Review. No abstract available.
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- 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. Review.
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- Simmer K, Patole SK, Rao SC. Longchain polyunsaturated fatty acid supplementation in infants born at term. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD000376. Review.
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- Hoffman DR, Birch EE, Castañeda 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.
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- 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.
- 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.
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- 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.
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- Innis SM. Human milk: maternal dietary lipids and infant development. Proc Nutr Soc. 2007 Aug;66(3):397-404. Review.
- Koletzko B, Lien E, Agostoni C, Böhles 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.
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- 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.
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| |
| Recruiting |
| 80 |
| September 2014 |
| September 2014 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Lactating women more than 1 month and less than 4 month with neonate whom term is between 37 and 42 gestational age
- Women who agree to consume fatty fish two times per week
- Free consent
Exclusion Criteria:
- Women with multiple infants
- Chronic treatments more than 8 days
- Women with treatment during supplementation period
- Women with maternal pathology not compatible with breastfeed
|
| Female |
| 18 Years to 55 Years |
| Yes |
|
|
| France |
| |
| NCT01288313 |
| 2010/35, 2008-058 |
| No |
| University Hospital, Bordeaux |
| University Hospital, Bordeaux |
| ITERG |
| Study Chair: |
Paul PEREZ, MD, PhD |
University Hospital Bordeaux (France) |
|
|
| University Hospital, Bordeaux |
| May 2013 |