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

Infant Nutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01627015
• Other study ID #: 114-12
• Status: Completed
• Phase: N/A
• First received: June 21, 2012
• Last updated: March 6, 2015
• Start date: June 2012
• Est. completion date: April 2014

Study information

• Verified date: March 2015
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Months to 6 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Infant Nutrition

Intervention

Other:
• Modified infant follow-on formula
The modified infant follow-on formula has a different carbohydrate pattern than the standard formula
• Standard infant follow-on formula
Infants are fed a commercial follow-on formula

Locations

Country	Name	City	State
Germany	Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of Munich	Munich

Sponsors (2)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	Beneo GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	metabolic response	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.	After 4 week intervention period	No