Safety, Acceptance and Metabolic Effects in Infants Receiving a Novel Low Glycaemic Index follow-on Formula

Ludwig Maximilian University of Munich

Status: Completed

Conditions: Infant Nutrition

Treatments: Other: Modified infant follow-on formula; Other: Standard infant follow-on formula

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01627015

114-12

Details and patient eligibility

About

In this study, the safety, acceptance and metabolic effects in infants receiving a novel low glycaemic index follow-on formula will be investigated.

After 4 week intervention period, metabolic response after feeding is significantly different between a follow-on formula containing low glycaemic carbohydrate and a conventional follow-on formula containing higher glycaemic carbohydrates.

Enrollment: 50 patients

Sex: All

Ages: 4 to 6 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• generally healthy infants born
• weight between 10th and 90th percentile for age, according to the EURO Growth guidelines
• age between 5 - 7th month of life at study entry
• fully formula fed for at least 4 weeks before intervention start
• parents/caregivers understand the German language and are able to fill out questionnaires
• parents/caregivers agree to study participation and sign the informed consent form

Exclusion criteria

• acute or chronic illness of infant or mother
• drug and/or alcohol abuses of mother
• chronic medication
• participation of the infant in another intervention study
• gestational diabetes of the mother

Trial design

50 participants in 2 patient groups

Modified infant follow-on formula

Experimental group

Description:

Infants are fed a modified infant follow-on formula (modified carbohydrate composition) for 4 weeks, according to protocol

Treatment:

Other: Modified infant follow-on formula

Standard infant follow-on formula

Active Comparator group

Description:

Infants are fed a commercial follow-on formula for 4 weeks, according to protocol

Treatment:

Other: Standard infant follow-on formula