Polyunsaturated Fatty Acids in Child Nutrition

Fatty Acid Status Clinical Trial

— PINGU  

Official title:

Polyunsaturated Fatty Acids in Child Nutrition - A German Multimodal Optimisation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01487889
• Other study ID #: PINGU0911DO
• Status: Completed
• Phase: N/A
• First received: September 15, 2011
• Last updated: November 5, 2014
• Start date: April 2011
• Est. completion date: September 2013

Study information

• Verified date: November 2014
• Source: Research Institute of Child Nutrition, Dortmund
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 8 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fatty Acid Status

Intervention

Other:
• 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

Locations

Country	Name	City	State
Germany	Research Institute of Child Nutrition	Dortmund

Sponsors (4)

Lead Sponsor	Collaborator
Research Institute of Child Nutrition, Dortmund	Dr. von Hauner Children's Hospital, Germany, Pediatric Clinic Dortmund, Germany, University of Potsdam

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Infants´ visual development	Infants´ visual development is assessed using the visual evoked potentials method.	10 months after delivery	No
Secondary	Infants´ cognitive development	Infants´ cognitive development is assessed using the Bayley II scale.	10 months after delivery	No
Secondary	Infants´ haemogram		10 months after delivery	No
Secondary	Infants´antioxidant status		10 months after delivery	No
Secondary	Infants´ body weight		10 months after delivery	No
Secondary	Infants´ dietary intake		from 2 until 10 months after delivery	No
Secondary	Maternal dietary intake		pregnancy and first 2 months post partum	No
Secondary	Infant's preference for fish		10 month after delivery	No
Secondary	Infant's preference for new flavour		10 month after delivery	No
Secondary	Parental attitudes about fish and feeding strategies		10 months after delivery	No
Secondary	Mother´s 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, cheek cells, and breast milk in order to assess the fatty acid composition.	2 months after delivery	No
Secondary	Infants´ body length		10 months after delivery	No
Secondary	Infant´s head circumference		10 months after delivery	No