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Completed

NCT Number: NCT02031003

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

* 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.

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Key information

Conditions

Bottle Feeding Behavior Feeding Behavior

Age range

25 day–45 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Medical Foundation - LinKou Branch, Linkou District, Tao-Yuan County, Taiwan

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infant Formula

Dietary Supplement

Infant formula

Primary outcomes

  1. Stool Composition

    Time frame: Day 28

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

Secondary outcomes

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

    Time frame: Days 14 and 28

    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).

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

    Time frame: Day 14 and 28

    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.

  3. GI Tolerance

    Time frame: Baseline, Day 14 and Day 28

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

  4. Incidence of adverse events

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

  5. Anthropometric measurements

    Time frame: Baseline, Day 14 and Day 28

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

  6. Anthropometric measurements (z-scores)

    Time frame: Baseline, Day 14 and Day 28

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

  7. Urine osmolality

    Time frame: Baseline and Day 28

    Measure of hydration status

  8. Urine pH

    Time frame: Baseline and Day 28

    Measure of hydration status

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Effect of an Infant Formula With High 2-Palmitic Vegetable Oil or an Identical Formula Supplemented With Oligofructose on Stool Composition and Stool Characteristics in Healthy Term Infants in Taiwan

Acronym: 9055A1-2000

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 9, 2014
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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