Efficacy and Safety of an Infant Formula With Milkfat and Prebiotics

Not Applicable

Completed

• Conditions: Stool Biochemistry; Constipation; Stool Flora; Infections; Food Intolerance
• Interventions: Dietary Supplement: new infant formula with prebiotics and beta-palmitate

• Registration Number: NCT01603719
• Lead Sponsor: Waldkrankenhaus Protestant Hospital, Spandau

Brief Summary

The purpose of this clinical trial is to evaluate the effect of a new infant starter formula with added prebiotics (GOS) and with a fat blend rich in beta-palmitate.

Detailed Description

An experimental infant formula with added prebiotics (GOS) and with a higher content of palmitic acid esterified in beta-position is to be tested in a double-blinded randomized controlled trial.

The addition of prebiotics to an infant formula should favor growth of a beneficial bifidogenic intestinal flora and have positive effects on immunity, promote softer stool formation and short chain fatty acid content in the stools. Higher proportion of beta-palmitic acid esterified in 2nd position of the triglyceride should reduce formation of fatty acid-calcium soaps in the stools and promote calcium and fat absorption in the gut, therfor reduce symptoms of constipation and colics.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-05-15
• Study First Submitted QC: 2012-05-18
• Study First Posted: 2012-05-23
• Primary Completion: 2014-10
• Study Completion: 2020-01
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-05
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• healthy term neonates
• gestational age 37 to 42 weeks
• birth weight 10th to 90th percentile (Voigt reference)
• infants being exclusively formula-fed at enrollment

Exclusion Criteria

• infants with high risk of atopic disease due to family history
• congenital disorder or syndrome with need for special diet / impairment of growth
• antibiotic medication prior to enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental formula	new infant formula with prebiotics and beta-palmitate	infant formula with higher beta-palmitate and supplemented GOS

Primary Outcome Measures

Name	Time	Method
number of gastrointestinal infections	within first year of life

Secondary Outcome Measures

Name	Time	Method
number of infectious episodes (gastrointestinal, respiratory, fever episodes)	within first year of life
symptoms of food intolerance, constipation, colics	after 6 weeks, 12 weeks intervention	number of episodes with colics, vomiting, abdominal bloating, intestinal gas; stool frequency, stool consistency, constipation
atopic manifestation	within 1st year of life	incidence atopic dermatitis
anthropometric parameters (gain in weight, length, head circumference)	after 6 weeks, after 12 weeks intervention
proportion of bifidobacteria on total stool bacteria	after 6 and 12 weeks intervention
stool biochemistry (calcium-fatty acid soaps, short chain fatty acids content in the stools)	after 6 weeks, 12 weeks intervention
calcium absorption	after 6 weeks, 12 weeks intervention	urinary calcium-creatinin ratio, serum alkaline phosphatase
erythrocytes´ fatty acid profile	after 6 weeks intervention	palmitic acid, linolic acid, alpha-linoleic acid, AA, DHA, EPA etc content (erythrocytes membrane)

Trial Locations

Locations (1)

Evangelisches Waldkrankenhaus Spandau; 🇩🇪 Berlin, Germany