How Effect Olive Oil and Eoprotin on Immunological Parameters and Growth

NCT02832011 | Unknown DMC

• 1 other identifier: 2015-TF-U362
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to compare immunologic parameters of 60 patients who are 1-28 days-aged, below 1500-gram body weight, born before 32 weeks of gestational age and fed with eoprotin or olive-oil fortified breast milk. Cases will receive same amount of calorie intake either with eoprotin or olive oil fortified-breast milk. If investigators identify that olive oil doesn't increase proinflammatory cytokines and grant enough weight gain in premature infants at the end of the study, investigators will suggest olive oil to replace eoprotin which is a very costly breast milk-fortifier.

Conditions

Breast Milk Expression; Premature Birth of Newborn

Outcome Measures

Primary Outcomes (9)

• serum alpha tumor necrosis factor will be analyzed

  For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge. At the end of the study, participants will be analyzed tumor necrosis factor alpha with ELISA method by BIO-Tec ELx800 Absorbance Reader device ;

  Within18 months

• IL-1 Beta will be analyzed

  For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge. At the end of the study, participants will be analyzed IL-1 with ELISA method by BIO-Tec ELx800 Absorbance Reader device ;

  Within18 months

• IL-6 will be analyzed

  For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge. At the end of the study, participants will be analyzed IL-6 with ELISA method by BIO-Tec ELx800 Absorbance Reader device ;

  Within18 months

• IL-8 will be analyzed

  For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge. At the end of the study, participants will be analyzed IL-8 with ELISA method by BIO-Tec ELx800 Absorbance Reader device ;

  Within18 months

• IL-10 will be analyzed

  For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge. At the end of the study, participants will be analyzed IL-10 with ELISA method by BIO-Tec ELx800 Absorbance Reader device ;

  Within18 months

• Triglyceride will be analyzed

  For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge. At the end of the study, participants will be analyzed triglyceride with spectrophotometric method by Architect ci16200;

  Within18 months

• Total cholesterol will be analyzed

  For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge. At the end of the study, participants will be analyzed total cholesterol with spectrophotometric method by Architect ci16200;

  Within18 months

• Low density lipoprotein (LDL) will be analyzed

  For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge. At the end of the study, participants will be analyzed Low density lipoprotein (LDL) with spectrophotometric method by Architect ci16200;

  Within18 months

• High density lipoprotein (HDL) will be analyzed

  For 45 days, 30 patients will receive eoprotin as breast milk fortifier while another 30 patients will receive olive oil, then 3 cc of blood will be taken from all patients at 0, 15., 30. and 45. days into biochemistry vials and will be stored at -80 C after centrifuge. At the end of the study, participants will be analyzed High density lipoprotein (HDL) with spectrophotometric method by Architect ci16200;

  Within18 months

Secondary Outcomes (6)

• SIRS (systemic inflammatory response syndrome)

  Within 3 months of life

• Chronic Lung Disease (CLD)

  up to 36 weeks of post gestational age

• Patent ductus arteriosus

  Within 5 days of life

• Intraventricular haemorrhage

  Within 1 month of life

• Necrotising enterocolitis

  Within 3 months of life

Study Arms (2)

olive oil

ACTIVE COMPARATOR

After randomization, Investigators will give human milk fortified with olive oil

Dietary Supplement: olive oil; Dietary Supplement: Eoprotin

Eoprotin

ACTIVE COMPARATOR

After randomization, Human milk fortified with Eoprotin according to the recommendations of the manufacturer (1g per 30ml milk)

Dietary Supplement: olive oil; Dietary Supplement: Eoprotin

Interventions

olive oil DIETARY_SUPPLEMENT

The infants fed with olive oil will have received same amount of calorie with infants who will receive eoprotin-fortified breast milk.

Also known as: Komili (extra virgin olive oil)

Eoprotin; olive oil

Eoprotin DIETARY_SUPPLEMENT

Low birth weight infants are premature infants that born with birth weight less than 1500 g. Because these infants have low birth weight, weight gain can be increased by fortifying breast milk after post-natal 7 with eoprotin.

Also known as: aptamil

Eoprotin; olive oil

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants with \<1500 g birth weight
• Infants with\< 32 weeks of gestational age
• Infants who will be fed with maternal milk that is fortified with eoprotin and olive oil

You may not qualify if:

• Critical ill patients
• Evident severe congenital malformation
• Intolerance of feeding
• Evident gastrointestinal malformation

Sponsors & Collaborators

• nihat demir: lead

Related Publications (5)

• 1. Çelik HT, Yiğit Ş. Yenidoğan ve Prematüre Bebeklerde Parenteral Beslenmede Yenilikler. Hacettepe Tıp Dergisi 2009;40:176-189.

  BACKGROUND

• 2. Gülcan H. Preterm Yenidoğanlarda Parenteral Beslenmede Yenilikler. Gaziantep Tıp Dergisi 2010;16:66-74.

  BACKGROUND

• 3. Gürsoy T, Yurdakök M. Prematüre Bebeklerin Beslenmesi. Çocuk Sağlığı ve Hastalıkları Dergisi 2008;51:240-251.

  BACKGROUND

• 4. Ergin H, Kılıç İ, Gürses D, Sözeri A, Özdemir C. Zenginleştirilmiş Anne Sütü (Eoprotin) Alan Prematüre Bebeklerde Vücut Ağırlığının Değişimi. ADU Tıp Fakültesi Dergisi 2000;1:9-11.

  BACKGROUND

• Gawecka A, Michalkiewicz J, Kornacka MK, Luckiewicz B, Kubiszewska I. Immunologic properties differ in preterm infants fed olive oil vs soy-based lipid emulsions during parenteral nutrition. JPEN J Parenter Enteral Nutr. 2008 Jul-Aug;32(4):448-53. doi: 10.1177/0148607108319802.

  PMID: 18596318 RESULT

MeSH Terms

Conditions

Breast Milk Expression; Premature Birth

Interventions

Olive Oil; Aptamil

Condition Hierarchy (Ancestors)

Breast Feeding; Feeding Behavior; Behavior; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• nihat demir

  Yuzuncu Yil University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 13, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 13, 2016

Record last verified: 2016-07