Effect of n-3 Polyunsaturated Fatty Acids Supplementation on Human Milk Composition of Lactating Women - Full Text View

Purpose

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

Condition	Intervention
Nursing Women	Dietary Supplement: nutritional intervention

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Olive oil

U.S. FDA Resources

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:

Acide linolenic 18 :3 n-3 analysis measured at day 30, compared to day 15 [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	80
Study Start Date:	September 2011
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: rapeseed oil	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.
Experimental: n-3 margarine and rapeseed oil	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.
Experimental: n-3 margarine	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.
Active Comparator: Olive oil	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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Lactating women more than 1 month and less than 3 month with neonate whom term is between 37 and 41 gestational age
Women who agree to consume fatty fish two times per week
Women who agree to give their human milk to lactarium
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288313

Contacts

Contact: Claude BILLEAUD, MD

+33 (0)5 56 79 56 35

claude.billeaud@chu-bordeaux.fr

Locations

France
Lactarium Hôpital Pellegrin Enfants CHU Bordeaux	Recruiting
Bordeaux, France, 33076
Contact: Claude BILLEAUD, MD +33 (0)5 56 79 56 35 claude.billeaud@chu-bordeaux.fr
Principal Investigator: Claude BILLEAUD, MD
Sub-Investigator: Clément CASTELLA, MD
Lactarium CHU La Croix Rousse Lyon Néonatologie et Réanimation Néonatale	Not yet recruiting
Lyon, France, 69004
Principal Investigator: Jean-Charles PICAUD, PU-PH
Sub-Investigator: Rachel BUFFIN, MD
Lactarium CHU Montpellier Pédiatrie 2	Not yet recruiting
Montpellier, France, 34925
Principal Investigator: Gilles CAMBONIE, PU-PH
Lactarium Institut de Puériculture de Paris et de Périnatalogie	Not yet recruiting
Paris, France, 75014
Principal Investigator: Virginie RIGOURD, MD

Sponsors and Collaborators

University Hospital, Bordeaux

ITERG

Investigators

Study Chair:

Paul PEREZ, MD, PhD

University Hospital Bordeaux (France)

More Information

Publications:

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.

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.

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.

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.

Jørgensen 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.

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.

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. Review.

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.

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. Review.

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.

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.

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.

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.

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.

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.

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.

Billeaud C, Bouglé 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.

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.

Moltó-Puigmartí C, Castellote AI, Carbonell-Estrany X, López-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. 2010 Aug 25; [Epub ahead of print]

Responsible Party:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT01288313 History of Changes
Other Study ID Numbers:	2010/35, 2008-058
Study First Received:	January 31, 2011
Last Updated:	June 13, 2012
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:

human milk
polyunsaturated fatty acids
linolenic acid
rapeseed oil

ClinicalTrials.gov processed this record on May 16, 2013

Effect of n-3 Polyunsaturated Fatty Acids Supplementation on Human Milk Composition of Lactating Women (Oméga 3)