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

Bottle Feeding Clinical Trial

— 9055A1-2000  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02031003
• Other study ID #: B3611001
• Status: Completed
• Phase: N/A
• First received: December 23, 2013
• Last updated: January 7, 2014
• Start date: September 2010
• Est. completion date: December 2011

Study information

• Verified date: January 2014
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical 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.

• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 45 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bottle Feeding

Intervention

Dietary Supplement:
• Infant formula
Infant formula

Locations

Country	Name	City	State
Taiwan	Mackay Memorial Hospital - Hsinchu Branch	Hsinchu
Taiwan	Chang Gung Medical Foundation - LinKuo Branch	Linkuo	Tao-Yuan County
Taiwan	Chang Gung Medical Foundation, Taipei Branch	Taipei
Taiwan	Mackay Memorial Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool Composition	Stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents	Day 28	No
Secondary	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).	Days 14 and 28	No
Secondary	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.	Day 14 and 28	No
Secondary	GI Tolerance	GI tolerance assessed by the Infant Gastrointestinal Symptom Questionnaire (IGSQ)	Baseline, Day 14 and Day 28	No
Secondary	Incidence of adverse events		From ICF signing until 14 days after last study feeding	No
Secondary	Anthropometric measurements (weight, length and head circumference)	Observed anthropometry measurements and derived z-scores will be determined and summarized by feeding group and by study visit.	Baseline, Day 14 and Day 28	No
Secondary	Urine osmolality	Measure of hydration status	Baseline and Day 28	Yes
Secondary	Urine pH	Measure of hydration status	Baseline and Day 28	Yes