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Carbohydrate and Metabolism: a Pilot Study

Postprandial Serum Responses to Various Infant Formulas and Breast Milk in Infants- a Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02441296
Enrollment
30
Registered
2015-05-12
Start date
2013-10-31
Completion date
2016-03-31
Last updated
2020-11-04

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

Conditions

Infant, Metabolism

Brief summary

The optimal choice of carbohydrate in infant formula needs to be assessed in more detail. Lactose has conventionally been used in most milk-based infant formulas, but more recently lactose-free formulas based on corn syrup solids/maltodextrins have gained in popularity. However, the metabolic consequences have not been examined. In a pilot study, the investigators will assess the postprandial metabolic response to a meal of formula with either lactose or maltodextrins. A breastfed reference group is also included.

Interventions

OTHERFormula with lactose
OTHERFormula with maltodextrins

Sponsors

University of California, Davis
CollaboratorOTHER
Mead Johnson Nutrition
CollaboratorINDUSTRY
Umeå University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Months to 3 Months
Healthy volunteers
Yes

Inclusion criteria

* Healthy * Term infants (gestational age 37-42 weeks) * Birth weight 2500-4500g

Exclusion criteria

* Infant illness * Maternal diabetes * Maternal pregnancy complications

Design outcomes

Primary

MeasureTime frameDescription
Glucose levels2 hours (Change from baseline to 15 min, 30 min, 60 min, 90 min and 120 min)The change in serum glucose levels are monitored following a test meal from baseline to 15 min, 30 min, 60 min, 90 min and 120 minutes

Secondary

MeasureTime frameDescription
Insulin levels2 hours (Change from baseline to 15 min, 30 min, 60 min, 90 min and 120 min)The change in plasma insulin levels are monitored following a test meal at baseline, 15 min, 30 min, 60 min, 90 min and 120 minutes
Metabolite levels2 hours (Change from baseline to 15 min, 30 min, 60 min, 90 min and 120 min)The change in plasma metabolite levels are monitored (using metabolomics) following a test meal at baseline, 15 min, 30 min, 60 min, 90 min and 120 minutes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026