Effect of Infant Formulas Containing a New Fat Blend or the New Fat Blend Plus Fiber in Healthy T… (NCT02031003) | Clinical Trial Compass
CompletedNot Applicable
Effect of Infant Formulas Containing a New Fat Blend or the New Fat Blend Plus Fiber in Healthy Term Infants
Taiwan220 participantsStarted 2010-09
Plain-language 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.
Who can participate
Age range
25 Days – 45 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a new fat blend in infant formula and measured stool composition as the main outcome — what does stool composition actually tell us about whether a formula is safe and nutritionally adequate for my baby?
2Since this study is listed as Phase NA and focused on healthy term infants, does my baby meet the kind of profile that was studied, and is there anything about our specific situation that would make these findings less applicable to us?
3The trial compared formulas with a new fat blend, and one version also added fiber — how do I know which combination, if either, would be appropriate for my infant, and are there any concerns about introducing fiber at this early stage?
4Now that this trial is completed, have the results been published, and do they show any differences in stool patterns or digestive comfort between the new formula blends and standard formula that I should factor into my feeding decisions?
5Given that this was a formula study rather than a treatment for a medical condition, how does the evidence from a study like this compare to existing guidance on infant nutrition, and should I be considering standard commercially available formulas instead?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.