Skip to content

Effect of cow’s milk infant formula on neurodevelopment and growth in infants

Effect of 12-month supplementation of infant and follow-on formula with complex milk lipids on neurodevelopment and growth in healthy term infants

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001571460
Acronym
CLING
Enrollment
432
Registered
2016-11-14
Start date
2016-01-27
Completion date
2016-10-05
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Complex milk lipids are present in human breast milk and are thought to play an important role in neonatal development. Infant formula based on vegetable oils has lower complex lipid content than breast milk. The proposed study will test if enrichment of infant formula and follow-on formula using dairy ingredients with enhanced levels of complex milk lipids to match the upper end of breast milk levels will have a positive impact on neonatal growth and development.

Interventions

The intervention products are infant formula for 0-6 month-old infants and follow-on formula for 6-12 month-old infants. All products comply with GB standard for nutritional composition. Healthy term infants in group 1 receive a infant formula and follow-on formula enriched in complex milk lipids to match the upper end of breast milk levels. Composition of the infant formula products for group 1 per 100 mL of reconstituted powder formula (67 kcal/100 mL): Protein 1.7 g, fat 3.4 g, carbohydrate

The intervention products are infant formula for 0-6 month-old infants and follow-on formula for 6-12 month-old infants. All products comply with GB standard for nutritional composition. Healthy term infants in group 1 receive a infant formula and follow-on formula enriched in complex milk lipids to match the upper end of breast milk levels. Composition of the infant formula products for group 1 per 100 mL of reconstituted powder formula (67 kcal/100 mL): Protein 1.7 g, fat 3.4 g, carbohydrate (lactose) 7.4 g, linoleic acid 400 mg, a-linolenic acid 45 mg, prebiotic, probiotic, vitamins and minerals. Composition of the follow-on formula products for group 1 per 100 kcal of reconstituted powder formula (68 kcal/100 mL): Protein 2.2 g, fat 3.2 g, carbohydrate (lactose) 7.8 g, linoleic acid 360 mg, prebiotic, probiotic, vitamins and minerals. Up to 2 weeks of age, infants will be fed 7-8 times 60 mL of formula by their parent or caregiver at home. Up to 4 weeks of age, infants will be fed 7-8 times 90 mL of formula by their parent or caregiver at home. Up to 2 months of age, infants will be fed 6-7 times 120 mL of formula by their parent or caregiver at home. Up to 4 months of age, infants will be fed 5-6 times 150 mL of formula by their parent or caregiver at home. Up to 6 months of age, infants will be fed 5-6 times 180 mL of formula by their parent or caregiver at home. Between 6 and 12 months of age, infants will be fed 3-4 times 210 mL of formula by their parent or caregiver at home. It is expected that weaning foods will be introduced from 6 months. All infant feeding will be monitored by every scheduled visit, we also will collect and record number of empty cans of formula milk from each infant’s parent throughout the trial.

Sponsors

Charles Sturt University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
1 Days to 21 Days
Healthy volunteers
Yes

Inclusion criteria

Healthy full term infants, born at gestational age between 35 and 41 weeks and with a birth body weight between 2500 and 4000 g

Exclusion criteria

Neonates with Apgar score <7 Neonates with a major birth defect or evidence of genetic disease Preterm infants (less than 35 weeks) Term infants born less than 2500 g or more than 4000 g.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026