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

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

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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