Carbohydrate and Metabolism: a Pilot Study

Umeå University

Status: Completed

Conditions: Metabolism; Infant

Treatments: Other: Formula with lactose; Other: Formula with maltodextrins

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02441296

2013-152-31M

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 3 to 3 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Infant illness
• Maternal diabetes
• Maternal pregnancy complications

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups

Formula with lactose

Experimental group

Description:

Carbohydrate-free formula with added lactose

Treatment:

Other: Formula with lactose

Formula with maltodextrins

Experimental group

Description:

Carbohydrate-free formula with added maltodextrins

Treatment:

Other: Formula with maltodextrins

Breastfeeding

No Intervention group

Description:

Breastfed reference group