Polyunsaturated Fatty Acids in Child Nutrition

NCT ID: NCT01487889

Last Updated: 2014-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2013-09-30

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.

Detailed Description

A well balanced supply of polyunsaturated fatty acids, in particular the omega-3 long chain docosahexaenoic acid (DHA), in early childhood is essential for children's cognitive and visual development. DHA can either be supplied preformed in the diet (e.g. via fatty fish) or synthesised by conversion of its essential precursor alpha-linolenic acid (e.g. via rapeseed oil). The study examines the effect of two different approaches to optimise infants´ fatty acid status.

The study sample consists of healthy newborns and their mothers (3 x 57 infants according to a priori power calculation) who are enrolled in delivery hospitals in the region of Dortmund, Germany. In total, the individual study program covers the first 10 months of infant's life. Biomarkers of fatty acid status from the mother are collected 8 weeks pp for the estimation of pre- and perinatal fatty acid supply. Additionally, information on maternal diet during pregnancy and after delivery is assessed. The intervention covers the period of complementary feeding (from 4 to 6 months of age until 10 months of age). In all groups the specific study food is given 5 to 7 times a week, whereas 2 of these are fish meals in the fatty fish group. At the age of 4 and 10 months blood samples are collected from the infants to examine the effect on blood fatty acid status. Parameters of visual and cognitive development are also assessed at the age of 4 and 10 months using VEP examinations and Bayley scales. Infants´ dietary intake is assessed from the end of the 2 months until 10 months of age using continuous weighed dietary records.

Conditions

Fatty Acid Status

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Rapeseed oil

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

Group Type: EXPERIMENTAL

Fatty acid composition of complementary food

Intervention Type: OTHER

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

Fatty fish

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

Group Type: EXPERIMENTAL

Fatty acid composition of complementary food

Intervention Type: OTHER

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

Corn oil

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

Group Type: ACTIVE_COMPARATOR

Fatty acid composition of complementary food

Intervention Type: OTHER

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

Interventions

Fatty acid composition of complementary food

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• preterm children
• twins

• Maximum Eligible Age: 8 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. von Hauner Children's Hospital, Germany

UNKNOWN

Sponsor Role: collaborator

University of Potsdam

OTHER

Sponsor Role: collaborator

Pediatric Clinic Dortmund, Germany

UNKNOWN

Sponsor Role: collaborator

Research Institute of Child Nutrition, Dortmund

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mathilde Kersting, Professor

Role: STUDY_DIRECTOR

Research Institute of Child Nutrition

Locations

Research Institute of Child Nutrition

Dortmund, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 26169870 (View on PubMed)

Other Identifiers

PINGU0911DO

Identifier Type: -

Identifier Source: org_study_id