NCT00831818

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 29, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

June 1, 2011

Status Verified

May 1, 2011

Enrollment Period

1.8 years

First QC Date

January 28, 2009

Last Update Submit

May 31, 2011

Conditions

Breastfeeding

Keywords

breastfeedingghrelinPYYappetite-regulation

Outcome Measures

Primary Outcomes (1)

  • ghrelin, PYY

    60 minutes

Secondary Outcomes (1)

  • insulin, C-peptide, oxytocin, prolactin

    60 minutes

Study Arms (2)

1

Mothers of healthy infants who breastfeed on demand

2

Mothers of healthy infants who do not breastfeed

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AKH, Medical University of Vienna

Vienna, A-1090, Austria

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Martin Clodi, MD

    Division of Endocrinology and Metabolism, Medical University of Vienna

    PRINCIPAL INVESTIGATOR

  • Anton Luger, MD

    Division of Endocrinology and Metabolism, Medical University of Vienna

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 28, 2009

First Posted

January 29, 2009

Study Start

July 1, 2008

Primary Completion

May 1, 2010

Study Completion

November 1, 2010

Last Updated

June 1, 2011

Record last verified: 2011-05

Locations

AU(1)