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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01627015

Enrollment

Registered

2012-06-25

Start date

2012-06-30

Completion date

2014-04-30

Last updated

2015-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant Nutrition

Keywords

Fully formula fed

Brief 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.

Interventions

OTHERModified infant follow-on formula

The modified infant follow-on formula has a different carbohydrate pattern than the standard formula

OTHERStandard infant follow-on formula

Infants are fed a commercial follow-on formula

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

4 Months to 6 Months

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
metabolic response	After 4 week intervention period	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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026