ClinicalTrials.Veeva

Menu

Effect of Infant Formulas Containing a New Fat Blend or the New Fat Blend Plus Fiber in Healthy Term Infants (9055A1-2000)

N

Nestlé

Status

Completed

Conditions

Bottle Feeding

Treatments

Dietary Supplement: Infant formula

Study type

Interventional

Funder types

Industry

Identifiers

NCT02031003
B3611001

Details and patient eligibility

About

  • The primary objective of the study was to compare stool composition (stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents) of infants randomized to receive either standard formula, or 1 of 2 innovative formulas containing a new fat blend or the new fat blend plus fiber.
  • The secondary objectives were to evaluate among the feeding groups, stool characteristics (stool consistency and frequency), GI tolerance assessed by the Infant Gastrointestinal Symptom Questionnaire (IGSQ), and urinary markers (F2-isoprostanes and 8-hydroxy-2'-deoxyguanosine [8-OHdG], and urine osmolality and specific gravity).
  • The primary safety objective was to describe the frequency of adverse events (AEs) among the formula-fed (FF) groups.
  • The secondary safety objective was to describe anthropometric measures (weight, length, and head circumference) among the feeding groups.

Enrollment

220 patients

Sex

All

Ages

25 to 45 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy, term (no less than 37 weeks and no greater than 42 weeks) singleton infants; between 25 days to 45 days post natal age (date of birth = Day 0) and weight for age ≥3rd and ≤97th percentiles according to Taiwan growth charts at the time of study entry.
  • Human milk fed infants were exclusively consuming and tolerating HM and the mother must have made the decision to continue to exclusively breastfeed.
  • Formula-fed infants were exclusively consuming and tolerating a cow's milk infant formula and parents/LAR must have previously made the decision to continue to exclusively formula feed.

Exclusion criteria

  • Infants receiving any amount of supplemental HM with infant formula feeding or vice versa
  • Family history of siblings with documented cow's milk protein intolerance/allergy
  • Major congenital malformations, suspected or documented systemic or congenital infections, evidence systemic diseases

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

220 participants in 4 patient groups

Control
Other group
Description:
Standard infant formula
Treatment:
Dietary Supplement: Infant formula
Experimental 1
Experimental group
Description:
Standard infant formula containing a new fat blend
Treatment:
Dietary Supplement: Infant formula
Experimental 2
Experimental group
Description:
Standard infant formula containing a new fat blend and fiber
Treatment:
Dietary Supplement: Infant formula
Human Milk (HM)
No Intervention group
Description:
Non-randomized Human Milk group

Trial contacts and locations

4

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems