NCT01805011

Brief Summary

This trial is undertaken to better understand the ranges of functional components normally found in human milk. This will strengthen the scientific knowledge on breast-milk composition as a "gold standard".

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2011

Shorter than P25 for all trials

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, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2013

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

10 months

First QC Date

March 4, 2013

Last Update Submit

September 5, 2024

Conditions

Healthy Mothers

Outcome Measures

Primary Outcomes (1)

  • levels of lipids

    The primary objective of this trial is to determine the levels of lipids normally found in the breast-milk of healthy lactating mothers

    After 1 month of Breastfeeding

Secondary Outcomes (1)

  • profile and quantity of sugars

    After 1 month of breastfeeding

Study Arms (1)

50 healthy mothers

Other: minimum 4 months of breastfeeding

Interventions

minimum 4 months of breastfeedingOTHER
50 healthy mothers

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy mothers

You may qualify if:

  • Gestational age between 37 and not above 42 weeks
  • years old ≤ Mother ≤ 40 years old
  • ≤ pre-pregnancy BMI ≤ 29
  • Mothers willing to breastfeed for the first 4 months

You may not qualify if:

  • Gestational diabetes
  • HTA \< 140/90
  • Mothers who are smokers while breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sprenger N, Lee LY, De Castro CA, Steenhout P, Thakkar SK. Longitudinal change of selected human milk oligosaccharides and association to infants' growth, an observatory, single center, longitudinal cohort study. PLoS One. 2017 Feb 9;12(2):e0171814. doi: 10.1371/journal.pone.0171814. eCollection 2017.

    PMID: 28182762DERIVED

MeSH Terms

Interventions

Lactation

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaPostpartum Period

Study Officials

  • Le Ye Lee, Assistant Professor

    NUHS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2013

First Posted

March 5, 2013

Study Start

July 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

September 19, 2024

Record last verified: 2024-09