Study on Short Chain Fatty Acids Concentration in Breast Milk and Its Correlation With the Maternal Diet

Short Chain Fatty Acids in Breast Milk

The purpose of this study is to determine whether the acetate, butyrate and propionate concentration in breast milk and to evaluate the possible correlation of these concentrations with maternal diet.

Study Overview

• Status: Unknown
• Conditions: Short Chain Fatty Acids Concentration in Breast Milk
• Intervention / Treatment: Other: sampling of breast milk, obtaining information about the maternal diet

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Annalisa Passariello, MD, PhD; Phone Number: + 39 081 746 2680; Email: annalisa.passariello@unina.it
• Study Contact Backup: Name: roberto berni canani, MD, PhD; Phone Number: + 39 081 746 2680; Email: berni@unina.it

Study Locations

• Italy
  • Naples, Italy, 80131
    • "Federico II" University of Naples
    • Contact: Annalisa Passariello, MD, PhD; Phone Number: + 39 081 746 2680; Email: annalisa.passariello@unina.it
    • Contact: roberto berni canani, MD, PhD; Phone Number: + 39 081 746 2680; Email: berni@unina.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

parturients women at term hospitalized in the Department of Obstetrics, Gynecology and Pathophysiology of Human Reproduction, "Federico II" University of Naples.

Description

Inclusion Criteria:

• parturients women at term hospitalized in the Department of Obstetrics, Gynecology and Pathophysiology of Human Reproduction, "Federico II" University of Naples.

Exclusion Criteria:

• infections,
• diabetes and other chronic diseases at the level of each organ or system,
• diseases of pregnancy.
• antibiotics, prebiotics, probiotics and synbiotics in the 30 days prior to the first observation.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
butyrate, acetate and propionate concentration	10 days after delivery and every 30 days until the fifth month after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between short chain fatty acids in breast milk and maternal diet (amount of fibers in maternal diet and based on this it will evaluate the variations in short chain fatty acids concentration)	Relationship between short chain fatty acids in breast milk and maternal diet will be measured by assessing the amount of fibers in maternal diet and based on this it will evaluate the variations in short chain fatty acids concentration. These assessments will be carried out by using a food diary carefully compiled by mothers before each sampling of breast milk	10 days after delivery and every 30 days until the fifth month after delivery

Collaborators and Investigators

• Sponsor: Federico II University
• Investigators: Principal Investigator: Annalisa Passariello, MD, PhD, "Federico II" University of Naples

Publications and helpful links

General Publications

• Topping DL, Clifton PM. Short-chain fatty acids and human colonic function: roles of resistant starch and nonstarch polysaccharides. Physiol Rev. 2001 Jul;81(3):1031-64. doi: 10.1152/physrev.2001.81.3.1031.
• Macfarlane S, Macfarlane GT. Regulation of short-chain fatty acid production. Proc Nutr Soc. 2003 Feb;62(1):67-72. doi: 10.1079/PNS2002207.
• Resta-Lenert S, Truong F, Barrett KE, Eckmann L. Inhibition of epithelial chloride secretion by butyrate: role of reduced adenylyl cyclase expression and activity. Am J Physiol Cell Physiol. 2001 Dec;281(6):C1837-49. doi: 10.1152/ajpcell.2001.281.6.C1837.
• Roediger WE. Role of anaerobic bacteria in the metabolic welfare of the colonic mucosa in man. Gut. 1980 Sep;21(9):793-8. doi: 10.1136/gut.21.9.793.
• Kunzelmann K, Mall M. Electrolyte transport in the mammalian colon: mechanisms and implications for disease. Physiol Rev. 2002 Jan;82(1):245-89. doi: 10.1152/physrev.00026.2001.
• Binder HJ, Mehta P. Short-chain fatty acids stimulate active sodium and chloride absorption in vitro in the rat distal colon. Gastroenterology. 1989 Apr;96(4):989-96. doi: 10.1016/0016-5085(89)91614-4.
• Boffa LC, Gruss RJ, Allfrey VG. Manifold effects of sodium butyrate on nuclear function. Selective and reversible inhibition of phosphorylation of histones H1 and H2A and impaired methylation of lysine and arginine residues in nuclear protein fractions. J Biol Chem. 1981 Sep 25;256(18):9612-21.
• Belderbos ME, Houben ML, van Bleek GM, Schuijff L, van Uden NO, Bloemen-Carlier EM, Kimpen JL, Eijkemans MJ, Rovers M, Bont LJ. Breastfeeding modulates neonatal innate immune responses: a prospective birth cohort study. Pediatr Allergy Immunol. 2012 Feb;23(1):65-74. doi: 10.1111/j.1399-3038.2011.01230.x. Epub 2011 Nov 22.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): January 1, 2015
• Study Completion (Anticipated): May 1, 2015

Study Registration Dates

• First Submitted: November 15, 2014
• First Submitted That Met QC Criteria: November 25, 2014
• First Posted (Estimate): November 26, 2014

Study Record Updates

• Last Update Posted (Estimate): November 26, 2014
• Last Update Submitted That Met QC Criteria: November 25, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: breast milk; short chain fatty acids; maternal diet
• Other Study ID Numbers: BMB-100