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Effects of Breastfeeding on Maternal Plasma Ghrelin and Peptide Tyrosine Tyrosine (PYY) Levels

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00831818
First received: January 28, 2009
Last updated: May 31, 2011
Last verified: May 2011
History of Changes
  Purpose

Weight retention after pregnancy contributes to increasing rates of obesity. There is evidence that breastfeeding is accompanied from changes in fat mobilisation and fat mass, nevertheless there are no data on the effects of breastfeeding on appetite-regulation. This study aims to investigate the direct effect of breastfeeding on the systemic levels of appetite-regulating hormones: ghrelin and PYY. Blood samples will be obtained at five time points (before, during and after breastfeeding) in ten mothers of healthy infants who breastfeed on demand and in ten mothers of healthy infants who do not breastfeed. All mothers will be fasting since 4 hours. The results will bring information on a possible direct effect of breastfeeding on appetite-regulatory hormones.


Condition
Breastfeeding

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects of Breastfeeding on Maternal Plasma Ghrelin and PYY Levels

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • ghrelin, PYY [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • insulin, C-peptide, oxytocin, prolactin [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood


Estimated Enrollment: 20
Study Start Date: July 2008
Study Completion Date: November 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Mothers of healthy infants who breastfeed on demand
2
Mothers of healthy infants who do not breastfeed

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Mothers of healthy infants (babies aged 3-6 months).

Criteria

Inclusion Criteria:

Group 1:

  • healthy mothers (with normal BMI) fully breastfeeding their infants (aged 3 to 6 months) on demand
  • past normal pregnancy

Group 2:

  • healthy mothers (with normal BMI) that do not breastfeed their infants (aged 3 to 6 months)
  • past normal pregnancy

Exclusion Criteria (for both groups):

  • current endocrine and metabolic disease of the mother
  • cardiocirculatory, kidney or liver disease of the mother
  • infants having growth problems or any other current disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00831818

Locations
Austria
AKH, Medical University of Vienna
Vienna, Austria, A-1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Martin Clodi, MD Division of Endocrinology and Metabolism, Medical University of Vienna
Study Chair: Anton Luger, MD Division of Endocrinology and Metabolism, Medical University of Vienna
  More Information

No publications provided

Responsible Party: Prof. Dr. Martin Clodi, Division of Endocrinology and Metabolism, Department of Medicine III, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00831818     History of Changes
Other Study ID Numbers: Breastfeeding_01
Study First Received: January 28, 2009
Last Updated: May 31, 2011
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
breastfeeding
ghrelin
PYY
appetite-regulation

ClinicalTrials.gov processed this record on May 16, 2013