Bottle Feeding9055A1-2000NCT02031003
Effect of Infant Formulas Containing a New Fat Blend or the New Fat Blend Plus Fiber in Healthy Term Infants
A study testing Infant formula in people with Bottle Feeding, run by Société des Produits Nestlé (SPN) at 4 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 daysHealthy volunteers can take part
- Conditions the study is for
- Bottle Feeding
- What is being tested?
- Infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 4 sitesTaiwan
- Study dates
- Sep 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
Taiwan4 sites
Mackay Memorial Hospital - Hsinchu Branch
Hsinchu
Chang Gung Medical Foundation - LinKou Branch
Linkou District, Tao-Yuan County
Chang Gung Medical Foundation, Taipei Branch
Taipei
Mackay Memorial Hospital
Taipei
About this study
Official 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
- 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
- Being tested
- Infant formula
- Medical subject headings
- Bottle Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant formulaDietary supplement
Infant formula
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Standard infant formula Receives: Dietary Supplement: Infant formula |
| Experimental 1 | Experimental | Standard infant formula containing a new fat blend Receives: Dietary Supplement: Infant formula |
| Experimental 2 | Experimental | Standard infant formula containing a new fat blend and fiber |
| Human Milk (HM) | No intervention | Non-randomized Human Milk group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool Composition
Stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents
Measured: Day 28
Secondary outcomes (8)
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).
Measured: Days 14 and 28
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.
Measured: Day 14 and 28
GI Tolerance
GI tolerance assessed by the Infant Gastrointestinal Symptom Questionnaire (IGSQ)
Measured: Baseline, Day 14 and Day 28
Incidence of adverse events
Measured: From ICF signing until 14 days after last study feeding
Anthropometric measurements
The anthropometry measurements will be determined by feeding group and by study visit.
Measured: Baseline, Day 14 and Day 28
Anthropometric measurements (z-scores)
The z-scores will be determined by feeding group and by study visit.
Measured: Baseline, Day 14 and Day 28
Urine osmolality
Measure of hydration status
Measured: Baseline and Day 28
Urine pH
Measure of hydration status
Measured: Baseline and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startSep 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bottle FeedingStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031003
- Sponsor's protocol ID
- B3611001
- Acronym
- 9055A1-2000
- Status last verified
- Jul 2026
- First submitted
- 23 Dec 2013
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02031003
- Acronym / sponsor ID
- 9055A1-2000 / B3611001
- Conditions
- Bottle Feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Dietary Supplement: Infant formulaStandard infant formula |
| Experimental 1 | Experimental | Dietary Supplement: Infant formulaStandard infant formula containing a new fat blend |
| Experimental 2 | Experimental | –Standard infant formula containing a new fat blend and fiber |
| Human Milk (HM) | No intervention | –Non-randomized Human Milk group |
Who may qualify
- Ages
- 25 to 45 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant formulaInfant formula | Dietary supplement | Control, Experimental 1 |
Primary outcome
Stool Composition
Time frame: Day 28
Stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents
8 secondary outcomes
Stool Consistency determined using a 3-day stool diary
Time frame: Days 14 and 28
Stool frequency determined using a 3-day stool diary
Time frame: Day 14 and 28
GI Tolerance
Time frame: Baseline, Day 14 and Day 28
Incidence of adverse events
Time frame: From ICF signing until 14 days after last study feeding
Anthropometric measurements
Time frame: Baseline, Day 14 and Day 28
Anthropometric measurements (z-scores)
Time frame: Baseline, Day 14 and Day 28
Urine osmolality
Time frame: Baseline and Day 28
Urine pH
Time frame: Baseline and Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Derived from this study: PubMed 25373935Nowacki 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.
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant formula in people with Bottle Feeding, run by Société des Produits Nestlé (SPN) at 4 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool Composition (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02031003, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.