Efficacy and Safety of an Infant Formula With Milkfat and Prebiotics

Safety and Efficacy of an Infant Starter Formula With Prebiotics (GOS) and a Higher Content of Beta-palmitate on Stool Characteristics, Food Tolerance, Calcium Uptake, and Incidence of Infectious Disease in the First Year of Life

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.

Study Overview

• Status: Completed
• Conditions: Infections; Constipation; Food Intolerance; Stool Flora; Stool Biochemistry
• Intervention / Treatment: Dietary supplement: new infant formula with prebiotics and 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 Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13589
    • Evangelisches Waldkrankenhaus Spandau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Formula; Standard formula with no supplementation
Experimental: experimental formula; infant formula with higher beta-palmitate and supplemented GOS	Dietary supplement: new infant formula with prebiotics and beta-palmitate; experimental infant formula as sole source of nutrition over first 12 weeks of life

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of gastrointestinal infections	within first year of life

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Waldkrankenhaus Protestant Hospital, Spandau
• Investigators: Principal Investigator: Frank Jochum, MD, Waldkrankenhaus Protestant Hospital, Spandau

Publications and helpful links

General Publications

• Lambidou M, Alteheld B, Fimmers R, Jochum F, Nomayo A, Stehle P. Impact of an Infant Formula Containing a Novel Fat Blend (Cow's Milk Fat, Fish and Vegetable Oil) and Prebiotics on Stool Fatty Acid Soaps and Erythrocyte Fatty Acid Profiles in Full-Term Healthy Newborns. Ann Nutr Metab. 2021;77(3):138-145. doi: 10.1159/000515705. Epub 2021 Apr 30.
• Nomayo A, Schwiertz A, Rossi R, Timme K, Foster J, Zelenka R, Tvrdik J, Jochum F. Infant formula with cow's milk fat and prebiotics affects intestinal flora, but not the incidence of infections during infancy in a double-blind randomized controlled trial. Mol Cell Pediatr. 2020 Jul 2;7(1):6. doi: 10.1186/s40348-020-00098-1.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: May 15, 2012
• First Submitted That Met QC Criteria: May 18, 2012
• First Posted (Estimate): May 23, 2012

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 5, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: prebiotics; infant formula; beta-palmitate; stool flora; bifidogenic
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Food Intolerance
• Other Study ID Numbers: EWK-001