Effect of Infant Formulas Containing a New Fat Blend or the New Fat Blend Plus Fiber in Healthy Term Infants

NCT02031003 | Completed

• 1 other identifier: B3611001
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 4

Brief Summary

• 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.

Conditions

Bottle Feeding

Outcome Measures

Primary Outcomes (1)

• Stool Composition

  Stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents

  Day 28

Secondary Outcomes (8)

• Stool Consistency determined using a 3-day stool diary

  Days 14 and 28

• Stool frequency determined using a 3-day stool diary

  Day 14 and 28

• GI Tolerance

  Baseline, Day 14 and Day 28

• Incidence of adverse events

  From ICF signing until 14 days after last study feeding

• Anthropometric measurements

  Baseline, Day 14 and Day 28

Study Arms (4)

Control

OTHER

Standard infant formula

Dietary Supplement: Infant formula

Experimental 1

EXPERIMENTAL

Standard infant formula containing a new fat blend

Dietary Supplement: Infant formula

Experimental 2

EXPERIMENTAL

Standard infant formula containing a new fat blend and fiber

Dietary Supplement: Infant formula

Human Milk (HM)

NO INTERVENTION

Non-randomized Human Milk group

Interventions

Infant formula DIETARY_SUPPLEMENT

Infant formula

Control; Experimental 1; Experimental 2

Eligibility Criteria

• Age: 25 Days - 45 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (4)

Chang Gung Medical Foundation - LinKou Branch

Linkou District, Tao-Yuan County, Taiwan

Location

Mackay Memorial Hospital - Hsinchu Branch

Hsinchu, Taiwan

Location

Chang Gung Medical Foundation, Taipei Branch

Taipei, Taiwan

Location

Mackay Memorial Hospital

Taipei, Taiwan

Location

Related Publications (1)

• Nowacki J, Lee HC, Lien R, Cheng SW, Li ST, Yao M, Northington R, Jan I, Mutungi G. Stool fatty acid soaps, stool consistency and gastrointestinal tolerance in term infants fed infant formulas containing high sn-2 palmitate with or without oligofructose: a double-blind, randomized clinical trial. Nutr J. 2014 Nov 5;13:105. doi: 10.1186/1475-2891-13-105.

  PMID: 25373935 DERIVED

MeSH Terms

Conditions

Bottle Feeding

Interventions

Infant Formula

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Milk Substitutes; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food, Formulated; Foods, Specialized; Food; Infant Food; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2013
• First Posted: January 9, 2014
• Study Start: September 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

TW (4)