CClinicalTrials.gg
Sign In
CompletedNCT020310039055A1-2000Updated Jul 30, 2026

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

An interventional study of Infant formula in Bottle Feeding, sponsored by Société des Produits Nestlé (SPN). Completed at 4 sites in Taiwan. Open to participants aged 25 Days to 45 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by Société des Produits Nestlé (SPN) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
25 Days to 45 Days
Sex
All
01

Study 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.
02

Conditions studied

  • Bottle Feeding
03

In context

Lead sponsor

Société des Produits Nestlé (SPN) is the lead sponsor of 314 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Days to 45 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
220 participants (actual)

Study arms

  • Other
    Control

    Standard infant formula

    Dietary Supplement: Infant formula

  • Experimental
    Experimental 1

    Standard infant formula containing a new fat blend

    Dietary Supplement: Infant formula

  • Experimental
    Experimental 2

    Standard infant formula containing a new fat blend and fiber

  • No intervention
    Human Milk (HM)

    Non-randomized Human Milk group

Interventions

  • Dietary supplementInfant formula

    Infant formula

06

What researchers measure

Primary outcomes

  1. Stool Composition

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

    Time frame: Day 28

Secondary outcomes

  1. Stool Consistency determined using a 3-day stool diary

    Stool consistency data is collected using a 3-day stool diary completed by parents just prior to the Day 14 and Day 28 clinic visits. Average stool consistency scores are recorded on a validated 5-point scale (1 = Watery, 2 = Runny, 3 = Mushy Soft, 4 = Formed, 5 = Hard).

    Time frame: Days 14 and 28

  2. Stool frequency determined using a 3-day stool diary

    Stool frequency data is collected using a 3-day stool diary completed by parents just prior to the Day 14 and Day 28 clinic visits. The average number of stools per day is determined for each consecutive 3-day period.

    Time frame: Day 14 and 28

  3. GI Tolerance

    GI tolerance assessed by the Infant Gastrointestinal Symptom Questionnaire (IGSQ)

    Time frame: Baseline, Day 14 and Day 28

  4. Incidence of adverse events

    Time frame: From ICF signing until 14 days after last study feeding

  5. Anthropometric measurements

    The anthropometry measurements will be determined by feeding group and by study visit.

    Time frame: Baseline, Day 14 and Day 28

  6. Anthropometric measurements (z-scores)

    The z-scores will be determined by feeding group and by study visit.

    Time frame: Baseline, Day 14 and Day 28

  7. Urine osmolality

    Measure of hydration status

    Time frame: Baseline and Day 28

  8. Urine pH

    Measure of hydration status

    Time frame: Baseline and Day 28

07

Study locations

4 sites
  • Chang Gung Medical Foundation - LinKou Branch
    Linkou District, Tao-Yuan County, Taiwan
  • Mackay Memorial Hospital - Hsinchu Branch
    Hsinchu, Taiwan
  • Chang Gung Medical Foundation, Taipei Branch
    Taipei, Taiwan
  • Mackay Memorial Hospital
    Taipei, Taiwan
08

References and documents

Publications

  • 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. PubMed 25373935 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02031003
Lead sponsor
Société des Produits Nestlé (SPN)
Responsible party
Sponsor
First posted
Jan 9, 2014
Start date
Sep 2010
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Jul 30, 2026

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Bottle Feeding

Other studies from this sponsor

Société des Produits Nestlé (SPN)

Start the discussion