NCT00362089

Brief Summary

Pregnant and lactating women receive n-3 fatty acids starting from week 15 of gestation until 4 months post-partum (pp) in comparison to a control group, who only gets information about adequately healthy nutrition during pregnancy and lactation. The amount of fat in newborns is measured through skinfold thickness, ultrasound, and magnetic resonance imaging (MRI). It is hypothesised that a reduction in arachidonic acid intake and an increase of n-3 LC PUFAs (long chain polyunsaturated fatty acids) via supplements containing docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) could lead to less expansive fat tissue development in the first year of life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2006

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

February 4, 2014

Status Verified

February 1, 2014

Enrollment Period

4.4 years

First QC Date

August 8, 2006

Last Update Submit

February 3, 2014

Conditions

OverweightObesity

Keywords

n-3 fatty acidsn-6 fatty acidslong chain polyunsaturated fatty acidspregnancylactationbreast feedingbreast milkadipose tissuenewbornfetal development

Outcome Measures

Primary Outcomes (1)

  • amount of fat mass in the offspring

    skinfold thickness measurements

    at birth, 6 weeks, 4 months, 1 year postpartum

Secondary Outcomes (22)

  • amount of fat mass in the offspring

    at 1,5 years, 2 years, 2.5 years, 3 years, 4 years and 5 years postpartum (follow-up)

  • offspring body height

    at birth, 6 weeks, 4 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years and 5 years postpartum

  • head circumference of newborns, infants and children

    at birth, 6 weeks, 4 months, 1 year, 1.5 years, 2 years, 2.5 years, 3 years, 4 years and 5 years postpartum

  • blood lipids of pregnant and lactating women

    15th wk gestation, 32nd wk gestation, 6 weeks pp, 4 months pp

  • fatty acid profile of phospholipids and erythrocyte membrane lipids, fatty acid metabolites

    15th wk gestation, 32nd wk gestation, birth, 6 wks, 4 months, 1 year, 3 years postpartum

  • +17 more secondary outcomes

Study Arms (2)

Marinol

ACTIVE COMPARATOR

Intervention group with Marinol D40 fish oil capsules

Dietary Supplement: Marinol D-40

Nutrition counseling

NO INTERVENTION

Control group

Interventions

Marinol D-40DIETARY_SUPPLEMENT

Marinol D-40, three capsules per day, from 15th week of gestation until 4th month of lactation

Marinol

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Gestational age \<= 15th week of gestation
  • Age: 18-43 years
  • Written informed consent
  • Body mass index (BMI) before pregnancy between 18 and 30 km/m2

You may not qualify if:

  • High risk pregnancy
  • Hypertonus
  • Chronic diseases (i.e. diabetes mellitus)
  • Psychiatric diseases
  • Former supplementation with LC-PUFA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Else Kröner-Fresenius-Zentrum für Ernährungsmedizin, Technische Universität München

Munich, 81675, Germany

Location

Related Publications (11)

  • Hauner H, Vollhardt C, Schneider KT, Zimmermann A, Schuster T, Amann-Gassner U. The impact of nutritional fatty acids during pregnancy and lactation on early human adipose tissue development. Rationale and design of the INFAT study. Ann Nutr Metab. 2009;54(2):97-103. doi: 10.1159/000209267. Epub 2009 Mar 19.

    PMID: 19295192BACKGROUND

  • Much D, Brunner S, Vollhardt C, Schmid D, Sedlmeier EM, Bruderl M, Heimberg E, Bartke N, Boehm G, Bader BL, Amann-Gassner U, Hauner H. Effect of dietary intervention to reduce the n-6/n-3 fatty acid ratio on maternal and fetal fatty acid profile and its relation to offspring growth and body composition at 1 year of age. Eur J Clin Nutr. 2013 Mar;67(3):282-8. doi: 10.1038/ejcn.2013.2. Epub 2013 Jan 23.

    PMID: 23340492BACKGROUND

  • Brunner S, Schmid D, Huttinger K, Much D, Bruderl M, Sedlmeier EM, Kratzsch J, Amann-Gassnerl U, Bader BL, Hauner H. Effect of reducing the n-6/n-3 fatty acid ratio on the maternal and fetal leptin axis in relation to infant body composition. Obesity (Silver Spring). 2014 Jan;22(1):217-24. doi: 10.1002/oby.20481. Epub 2013 Sep 10.

    PMID: 23596009BACKGROUND

  • Much D, Brunner S, Vollhardt C, Schmid D, Sedlmeier EM, Bruderl M, Heimberg E, Bartke N, Boehm G, Bader BL, Amann-Gassner U, Hauner H. Breast milk fatty acid profile in relation to infant growth and body composition: results from the INFAT study. Pediatr Res. 2013 Aug;74(2):230-7. doi: 10.1038/pr.2013.82. Epub 2013 May 28.

    PMID: 23715519BACKGROUND

  • Brunner S, Schmid D, Huttinger K, Much D, Heimberg E, Sedlmeier EM, Bruderl M, Kratzsch J, Bader BL, Amann-Gassner U, Hauner H. Maternal insulin resistance, triglycerides and cord blood insulin in relation to post-natal weight trajectories and body composition in the offspring up to 2 years. Diabet Med. 2013 Dec;30(12):1500-7. doi: 10.1111/dme.12298. Epub 2013 Sep 11.

    PMID: 23909286BACKGROUND

  • Hauner H, Much D, Vollhardt C, Brunner S, Schmid D, Sedlmeier EM, Heimberg E, Schuster T, Zimmermann A, Schneider KT, Bader BL, Amann-Gassner U. Effect of reducing the n-6:n-3 long-chain PUFA ratio during pregnancy and lactation on infant adipose tissue growth within the first year of life: an open-label randomized controlled trial. Am J Clin Nutr. 2012 Feb;95(2):383-94. doi: 10.3945/ajcn.111.022590. Epub 2011 Dec 28.

    PMID: 22205307RESULT

  • Meyer DM, Brei C, Stecher L, Brunner S, Hauner H. Maternal insulin resistance, triglycerides and cord blood insulin are not determinants of offspring growth and adiposity up to 5 years: a follow-up study. Diabet Med. 2018 Oct;35(10):1399-1403. doi: 10.1111/dme.13765. Epub 2018 Aug 2.

    PMID: 29938825DERIVED

  • Meyer DM, Brei C, Stecher L, Much D, Brunner S, Hauner H. The relationship between breast milk leptin and adiponectin with child body composition from 3 to 5 years: a follow-up study. Pediatr Obes. 2017 Aug;12 Suppl 1:125-129. doi: 10.1111/ijpo.12192. Epub 2016 Nov 10.

    PMID: 27863153DERIVED

  • Brei C, Stecher L, Much D, Karla MT, Amann-Gassner U, Shen J, Ganter C, Karampinos DC, Brunner S, Hauner H. Reduction of the n-6:n-3 long-chain PUFA ratio during pregnancy and lactation on offspring body composition: follow-up results from a randomized controlled trial up to 5 y of age. Am J Clin Nutr. 2016 Jun;103(6):1472-81. doi: 10.3945/ajcn.115.128520. Epub 2016 Apr 6.

    PMID: 27053380DERIVED

  • Brei C, Much D, Heimberg E, Schulte V, Brunner S, Stecher L, Vollhardt C, Bauer JS, Amann-Gassner U, Hauner H. Sonographic assessment of abdominal fat distribution during the first year of infancy. Pediatr Res. 2015 Sep;78(3):342-50. doi: 10.1038/pr.2015.108. Epub 2015 Jun 8.

    PMID: 26053137DERIVED

  • Brunner S, Schmid D, Zang K, Much D, Knoeferl B, Kratzsch J, Amann-Gassner U, Bader BL, Hauner H. Breast milk leptin and adiponectin in relation to infant body composition up to 2 years. Pediatr Obes. 2015 Feb;10(1):67-73. doi: 10.1111/j.2047-6310.2014.222.x. Epub 2014 Apr 14.

    PMID: 24729519DERIVED

MeSH Terms

Conditions

OverweightObesityBreast Feeding

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Study Officials

  • Hans Hauner, Prof.

    Else Kröner-Fresenius-Zentrum für Ernährungsmedizin, Technische Universität München

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 8, 2006

First Posted

August 9, 2006

Study Start

June 1, 2006

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

February 4, 2014

Record last verified: 2014-02

Locations

DE(1)