Evaluation of the Effect of Palm Olein Free Formula on Intestinal Flora and Gastrointestinal Tolerance

Depending on recent studies in literature the investigators aimed to compare whether gastrointestinal tolerance differs between infants fed with palm olein containing or palm olein free formulas. Besides it is showed that palm olein containing formulas decreases the absorption of fat and calcium by forming insoluble calcium soaps. So it is suggested that intestinal flora might be affected as a reason of these specialties. This study also aimed to investigate with culture-independent methods whether feeding infants with palm olein free formula results in the modification of their intestinal microbiota in such a way that is similar to breastfed ones.

Study Overview

• Status: Completed
• Conditions: Intestinal Bacteria Flora Disturbance; Feeding; Disorder, Nonorganic Origin; Calcium Disorder
• Intervention / Treatment: Other: Feeding with palm olein formula

Detailed Description

Recent studies in literature the investigators aimed to compare whether gastrointestinal tolerance differs between infants fed with palm olein containing or palm olein free formulas. Besides it is showed that palm olein containing formulas decreases the absorption of fat and calcium by forming insoluble calcium soaps. So it is suggested that intestinal flora might be affected as a reason of these specialties. This study also aimed to investigate with culture-independent methods whether feeding infants with palm olein free formula results in the modification of their intestinal microbiota in such a way that is similar to breastfed ones.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Turkey
  • Kucukcekmece
    • Istanbul, Kucukcekmece, Turkey, 34303
      • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A total of 90 healthy infants (30 under breast-feeding, 30 feeding with palm olein free formula and 30 feeding with palm olein formula) will be included. Infants feeding enterally more than %70 with breast milk will be considered as breast-feeding. Infants who had not adequate weight gain and need formula will be randomized to receive either palm olein or palm olein free term formula in addition to mother milk. Parental informed consent will be taken and infants whose parents give permission will be included.

Description

Inclusion Criteria:

The data of the patients who fulfilled the following criteria are evaluated.

1. Term infants between 38 and 40 weeks of gestational age and/or with a birth weight of > 2500grams who are either breastfed or formula fed.

   Selection of the subgroup using oral nutrition

2. Feeding predominantly with palm olein free formula if presence in addition to breast milk for 8 weeks of life
3. Feeding with other formulas including palm olein if presence in addition to breast milk for 8 weeks of life Selection of the subgroup not using oral nutritional supplement (control group)
4. Having similar demographical properties with infants feeding with breast milk (gender, age, weight, height)

Exclusion Criteria:

• Infants with major congenital abnormalities will be excluded.
• Infants with lack of data will also be excluded.
• Infants, whose parents don't agree with informed consent, will be excluded.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Infants feeding predominantly with palm olein free formula if presence in addition to breast milk for 8 weeks of life	Other: Feeding with palm olein formula
Group 2; Infants feeding with other formulas including palm olein if presence in addition to breast milk for 8 weeks of life
Group 3; Having similar demographical properties with infants feeding with breast milk (gender, age, weight, height)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool consistency	Amsterdam Infant Stool Scale	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacteria Count	number of the copy of DNA of Intestinal Flora Content	10 weeks

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital
• Investigators: Study Director: Seda Yilmaz Semerci, Kanuni SSTRH

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: May 11, 2016
• First Submitted That Met QC Criteria: December 6, 2018
• First Posted (Actual): December 10, 2018

Study Record Updates

• Last Update Posted (Actual): April 23, 2019
• Last Update Submitted That Met QC Criteria: April 22, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: ANCL034