Skip to main content
OpenTrials
Completed

NCT Number: NCT02441296

Carbohydrate and Metabolism: a Pilot Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infant Metabolism

Age range

3 month–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • Infant illness
  • Maternal diabetes
  • Maternal pregnancy complications

Treatment and study plan

Formula with lactose

Other

Formula with maltodextrins

Other

Primary outcomes

  1. Glucose levels

    Time frame: 2 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 outcomes

  1. Insulin levels

    Time frame: 2 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

  2. Metabolite levels

    Time frame: 2 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

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Mead Johnson Nutrition
  • University of California, Davis

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 12, 2015
Registry last updated
Nov 4, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.