Nursing WomenOméga 3NCT01288313
Effect of n-3 Polyunsaturated Fatty Acids Supplementation on Human Milk Composition of Lactating Women
A study testing nutritional intervention in people with Nursing Women, run by University Hospital, Bordeaux at 4 sites in France.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nursing Women
- What is being tested?
- nutritional intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 4 sitesFrance
- Study dates
- Sep 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Women with multiple infants
- Chronic treatments more than 8 days
- Women with treatment during supplementation period
- Women with maternal pathology not compatible with breastfeed
Trial locations and contacts
4 sites in 1 country.
France4 sites
Lactarium Hôpital Pellegrin Enfants CHU Bordeaux
Bordeaux, 33076
Lactarium CHU La Croix Rousse Lyon Néonatologie et Réanimation Néonatale
Lyon, 69004
Lactarium CHU Montpellier Pédiatrie 2
Montpellier, 34925
Lactarium Institut de Puériculture de Paris et de Périnatalogie
Paris, 75014
About this study
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
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
Read the 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.
- Conditions
- Nursing Women
- Being tested
- nutritional intervention
- Keywords
- human milk, polyunsaturated fatty acids, linolenic acid, rapeseed oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional interventionDietary 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.
nutritional interventionDietary 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 interventionDietary 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 interventionDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| rapeseed oil | Experimental | Not described Receives: Dietary Supplement: nutritional intervention |
| n-3 margarine and rapeseed oil | Experimental | Not described Receives: Dietary Supplement: nutritional intervention |
| n-3 margarine | Experimental | Not described Receives: Dietary Supplement: nutritional intervention |
| Olive oil | Active comparator | Not described Receives: Dietary Supplement: nutritional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acide linolenic 18 :3 n-3 analysis measured at day 30, compared to day 15
Measured: 30 days
Secondary outcomes (4)
Analysis of linolenic acid and linoleic acid ratio
Measured: 30 days
Analysis of arachidonic acid, docosahexanoic acid and their ratio
Measured: 30 days
Comparison of fatty acid composition of human milk before and after supplementation
Measured: 30 days
Analysis of trans fatty acids according diets
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Nursing WomenStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- ITERG
- Responsible party
- Sponsor
- Investigators
- Paul PEREZ, MD, PhD, Study chair, University Hospital Bordeaux (France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288313
- Sponsor's protocol ID
- 2010/35
- Other IDs
- 2010-A01126-33
- Acronym
- Oméga 3
- Status last verified
- Aug 2014
- First submitted
- 31 Jan 2011
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11137568Sauerwald 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.
PubMed 9029636Cunnane 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.
PubMed 10695931Innis 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.
PubMed 11598600Jorgensen 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.
PubMed 11345178Simmer 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.
PubMed 18253974Uauy 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.
PubMed 14597910Hoffman 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.
PubMed 12838196SanGiovanni 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.
PubMed 10742608Innis 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.
PubMed 12032520Jensen 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.
PubMed 16002810Helland 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.
PubMed 12509593Fidler 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.
PubMed 10974044Birch 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.
PubMed 10755457Innis SM. Human milk: maternal dietary lipids and infant development. Proc Nutr Soc. 2007 Aug;66(3):397-404. doi: 10.1017/S0029665107005666.
PubMed 17637092
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01288313
- Acronym / sponsor ID
- Oméga 3 / 2010/35
- Conditions
- Nursing Women
- Keywords
- human milk, polyunsaturated fatty acids, linolenic acid, rapeseed oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- ITERG
- Study start
- Sep 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 2 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| rapeseed oil | Experimental | Dietary Supplement: nutritional intervention |
| n-3 margarine and rapeseed oil | Experimental | Dietary Supplement: nutritional intervention |
| n-3 margarine | Experimental | Dietary Supplement: nutritional intervention |
| Olive oil | Active comparator | Dietary Supplement: nutritional intervention |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Women with multiple infants
- Chronic treatments more than 8 days
- Women with treatment during supplementation period
- Women with maternal pathology not compatible with breastfeed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutritional interventionEach 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 | rapeseed oil |
| nutritional interventionEach 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 | n-3 margarine and rapeseed oil |
| nutritional interventionEach 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 | n-3 margarine |
| nutritional interventionEach 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. | Dietary supplement | Olive oil |
Primary outcome
Acide linolenic 18 :3 n-3 analysis measured at day 30, compared to day 15
Time frame: 30 days
4 secondary outcomes
Analysis of linolenic acid and linoleic acid ratio
Time frame: 30 days
Analysis of arachidonic acid, docosahexanoic acid and their ratio
Time frame: 30 days
Comparison of fatty acid composition of human milk before and after supplementation
Time frame: 30 days
Analysis of trans fatty acids according diets
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 11137568Lauritzen 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.
- Background: PubMed 9029636Sauerwald 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.
- Background: PubMed 10695931Cunnane 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.
- Background: PubMed 11598600Innis 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.
- Background: PubMed 11345178Jorgensen 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.
- Background: PubMed 18253974Simmer 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.
- Background: PubMed 14597910Uauy 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.
- Background: PubMed 12838196Hoffman 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.
- Background: PubMed 10742608SanGiovanni 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.
- Background: PubMed 12032520Innis 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.
- Background: PubMed 16002810Jensen 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.
- Background: PubMed 12509593Helland 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul PEREZ, MD, PhD study chair
University Hospital Bordeaux (France)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutritional intervention in people with Nursing Women, run by University Hospital, Bordeaux at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acide linolenic 18 :3 n-3 analysis measured at day 30, compared to day 15 (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01288313, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.