NCT01487889

Brief Summary

Primary objective of this study is to examine the effects of 2 different approaches of dietary strategies to optimise fatty acid composition in complementary food on infant's fatty acid status and its consequences on cognitive and visual development. Subjects are randomly assigned to one of three groups:

  • Rapeseed oil (high in n-3 PUFA and small n-6:n-3 ratio to support endogenous n- 3 LC-PUFA metabolism)
  • Fatty fish (preformed n-3 LC-PUFA, especially DHA)
  • Corn oil (as control group, high in n-6 PUFA, common in complementary food). The intervention starts with the beginning of complementary feeding as generally recommended between 4 to 6 months of age and ends at the age of 10 months. For this period of time subjects of all groups receive commercial vegetable-potato-meat-meals as part of complementary food which only differs in the fatty acid composition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Typical duration 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

April 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 8, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

November 6, 2014

Status Verified

November 1, 2014

Enrollment Period

2.4 years

First QC Date

September 15, 2011

Last Update Submit

November 5, 2014

Conditions

Fatty Acid Status

Outcome Measures

Primary Outcomes (1)

  • Infants´ fatty acid status

    Fatty acids (saturated fatty acids, monounsaturated fatty acids, polyunsaturated fatty acids including long-chain polyunsaturated fatty acids) are measured in percent of total fatty acids in erythrocyte membranes, whole plasma, and cheek cells in order to assess the fatty acid composition.

    10 months after delivery

Secondary Outcomes (13)

  • Infants´ visual development

    10 months after delivery

  • Infants´ cognitive development

    10 months after delivery

  • Infants´ haemogram

    10 months after delivery

  • Infants´antioxidant status

    10 months after delivery

  • Infants´ body weight

    10 months after delivery

  • +8 more secondary outcomes

Study Arms (3)

Rapeseed oil

EXPERIMENTAL

Study group receive commercial vegetable-potato-meat-meals containing rapeseed oil as part of complementary food

Other: Fatty acid composition of complementary food

Fatty fish

EXPERIMENTAL

Study group receive 2 times per week a vegetable-potato-meat-meals as part of complementary food.

Other: Fatty acid composition of complementary food

Corn oil

ACTIVE COMPARATOR

Study group receive commercial vegetable-potato-meat-meals containing corn oil as part of complementary food

Other: Fatty acid composition of complementary food

Interventions

Fatty acid composition of complementary foodOTHER

Groups receive commercial vegetable-potato-meat-meals as part of complementary food which differs in the fatty acid composition

Corn oilFatty fishRapeseed oil

Eligibility Criteria

AgeUp to 8 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • a term healthy newborn infant ( birth weight \> 2500 g, gestational age \> 37 weeks
  • German speaking mother
  • the intention of the mother to breast-feed the children and to feed study menus at least 5 times per week beginning in the fifth to seventh month of life.

You may not qualify if:

  • preterm children
  • twins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Institute of Child Nutrition

Dortmund, 44225, Germany

Location

Related Publications (1)

  • Libuda L, Mesch CM, Stimming M, Demmelmair H, Koletzko B, Warschburger P, Blanke K, Reischl E, Kalhoff H, Kersting M. Fatty acid supply with complementary foods and LC-PUFA status in healthy infants: results of a randomised controlled trial. Eur J Nutr. 2016 Jun;55(4):1633-44. doi: 10.1007/s00394-015-0982-2. Epub 2015 Jul 14.

    PMID: 26169870DERIVED

Study Officials

  • Mathilde Kersting, Professor

    Research Institute of Child Nutrition

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2011

First Posted

December 8, 2011

Study Start

April 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

November 6, 2014

Record last verified: 2014-11

Locations

DE(1)