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OpenTrials
Completed

NCT Number: NCT01611649

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

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.

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Key information

Conditions

Infant Development

Age range

Up to 21 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinica Mangiagalli

Milan, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Formula containing dairy lipids and plant oils

Dietary Supplement

4 months consumption

Formula containing plant oils

Dietary Supplement

4 months consumption

Formula containing dairy lipids and plant oils, DHA+ARA

Dietary Supplement

4 months consumption, DHA+ARA supplemented formula containing dairy lipids and plant oils

Primary outcomes

  1. Sum of omega-3 fatty acid levels in membrane phospholipids of RBC

    Time frame: after 4 months of consumption

    alpha linolenic acid (ALA) + eicosapentaenoic acid (EPA) + docosapentaenoic acid (DPA) + docosahexaenoic acid (DHA)

Secondary outcomes

  1. Serum total fatty acid levels

    Time frame: after 4 months of consumption

  2. Insulin-like Growth Factor 1 (IGF1) blood levels

    Time frame: after 4 months of consumption

  3. Lipid profile (triglyceride, high-density lipoprotein HDL, low-density lipoprotein LDL, total cholesterol)

    Time frame: after 4 months of consumption

  4. Amount of formula consumed, occurrence of spit-up and vomit, description of the number, color and consistency of infant stools as a measure of tolerance to the formula

    Time frame: during the 4 months consumption period

  5. Growth parameters: weight, height, head circumference and body composition: amount of lean and fat mass

    Time frame: during the 4 months consumption period

  6. Total fatty acid levels in membrane phospholipids of RBC

    Time frame: after 4 months of consumption

  7. Evolution of blood total fatty acids levels between 0 and 4 months

    Time frame: between 0 and 4 months

Sponsors and collaborators

Lead sponsor

Lactalis

Industry

Registry information

Official study title

Profilo Degli Acidi Grassi Omega-3 Dei Globuli Rossi in Neonati Sani Alimentati Con Una Formula Per l'Infanzia Contenente Una Miscela di Grassi Del Latte e Oli Vegetali

Acronym: REBECA

Important dates

Study start
2012
Primary completion
2013
First posted
Jun 5, 2012
Registry last updated
Apr 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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