Carbohydrate and Metabolism: a Pilot Study

Metabolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02441296
• Other study ID #: 2013-152-31M
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: March 2016

Study information

• Verified date: November 2020
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 3 Months

Eligibility

Inclusion Criteria:

• Healthy

• Term infants (gestational age 37-42 weeks)

• Birth weight 2500-4500g

Exclusion Criteria:

• Infant illness

• Maternal diabetes

• Maternal pregnancy complications

Related Conditions & MeSH terms

• Infant
• Metabolism

Intervention

Other:
• Formula with lactose

• Formula with maltodextrins

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Umeå University	Mead Johnson Nutrition, University of California, Davis

References & Publications (1)

Slupsky CM, He X, Hernell O, Andersson Y, Rudolph C, Lönnerdal B, West CE. Postprandial metabolic response of breast-fed infants and infants fed lactose-free vs regular infant formula: A randomized controlled trial. Sci Rep. 2017 Jun 16;7(1):3640. doi: 10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose levels	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	2 hours (Change from baseline to 15 min, 30 min, 60 min, 90 min and 120 min)
Secondary	Insulin levels	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 hours (Change from baseline to 15 min, 30 min, 60 min, 90 min and 120 min)
Secondary	Metabolite levels	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	2 hours (Change from baseline to 15 min, 30 min, 60 min, 90 min and 120 min)