Acceptability and GI Tolerance of an Alpha-lactalbumin-enriched Formula

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-10-31

Brief Summary

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A single center, non-controlled trial to document the gastrointestinal (GI) tolerability of the study formula (SF), containing a whey protein concentrate enriched with alpha-lactalbumin (WPC alpha-lac) fed for 6 weeks to healthy, term infants.

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Detailed Description

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The purpose of this study is to examine the tolerable and acceptability of an infant formula with with a Whey protein concentrate containing alpha-lactalbumin as measure by GI tolerance, and eating behaviors.

Conditions

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Infant Formula Intolerance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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S-26 Gold

Standard Infant Formula containing enriched with alpha-lactalbumin

Group Type EXPERIMENTAL

S-26 Gold

Intervention Type OTHER

A commercial whey protein dominant, first age formula, containing whey protein concentrate with alpha-lactalbumin

Interventions

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S-26 Gold

A commercial whey protein dominant, first age formula, containing whey protein concentrate with alpha-lactalbumin

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Written informed consent
2. Healthy, full term, singleton infant
3. Be between 28±7 days post-natal age
4. Infants at enrollment, weight-for-age ≥ 5th and ≤ 95th percentile according to World Health Organization growth tables / charts
5. Infants must be exclusively consuming and tolerating a cow's milk infant formula for a minimum of 3 consecutive days and parent(s)/LAR must have previously made the decision to continue to exclusively formula feed
6. Have sufficient command of Tagalog or English language to complete the informed consent and other study documents
7. Are willing and able to fulfill the requirements of the study protocol
8. Have reached the legal age of consent in the Philippines
9. Able to be contacted by telephone throughout the study

Exclusion Criteria

1. Infants who are receiving any amount of supplemental human milk
2. Family history of siblings with documented cow's milk protein intolerance/allergy
3. Conditions requiring infant feedings other than those specified in the protocol

Minimum Eligible Age

21 Days

Maximum Eligible Age

35 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes