Carbohydrate and Metabolism: a Pilot Study

Not Applicable

Completed

• Conditions: Metabolism; Infant
• Interventions: Other: Formula with maltodextrins; Other: Formula with lactose

• Registration Number: NCT02441296
• Lead Sponsor: Umeå University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2015-04-08
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-12
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• Infant illness
• Maternal diabetes
• Maternal pregnancy complications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Formula with maltodextrins	Formula with maltodextrins	Carbohydrate-free formula with added maltodextrins
Formula with lactose	Formula with lactose	Carbohydrate-free formula with added lactose

Primary Outcome Measures

Name	Time	Method
Glucose levels	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 Outcome Measures

Name	Time	Method
Insulin levels	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
Metabolite levels	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