Effect of a Mix of Dairy Lipids and Plant Oils in Infant Formula on Omega-3 Fatty Acid in Red Blood Cells (REBECA)

Lactalis

Status and phase: Completed; Phase 2

Conditions: Infant Development

Treatments: Dietary Supplement: Formula containing plant oils; Dietary Supplement: Formula containing dairy lipids and plant oils; Dietary Supplement: Formula containing dairy lipids and plant oils, DHA+ARA

Study type: Interventional

Funder types: Industry

Identifiers

NCT01611649

LRD-2012-REBECA

Details and patient eligibility

About

The objective of this study is to determine whether the use of a mix of dairy lipids and plant oils in infant formula can increase the sum of omega-3 fatty acids levels in membrane phospholipids of red blood cells (RBC) in 4 month-old infants compared with a formula containing only lipids of plant origin.

Enrollment: 117 patients

Sex: All

Ages: Under 21 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Full term healthy newborn from normal pregnancy
• Newborn whose mother decided to not breastfeed or to stop breastfeed before the third week of life

Exclusion criteria

• Newborn with low-birth-weight (<2500 g)
• Newborn whose parents have planned a move within 6 months after birth
• Family history of allergy to milk protein

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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117 participants in 4 patient groups

Dairy lipids and plant oils

Experimental group

Treatment:

Dietary Supplement: Formula containing dairy lipids and plant oils

Plant oils

Experimental group

Treatment:

Dietary Supplement: Formula containing plant oils

Dairy lipids and plant oils, DHA+ARA

Experimental group

Description:

DHA: docosahexaenoic acid, ARA: arachidonic acid

Treatment:

Dietary Supplement: Formula containing dairy lipids and plant oils, DHA+ARA

Human milk

No Intervention group