NCT05259059

Brief Summary

The first 1000 days, i.e., the earliest stage of life, is a unique period of opportunity to establish the foundations of human growth and health through the lifespan. In the recent decades, multiple studies have explored nutritional strategies for improving infant health through improving the nutritive and bioactive compositions in breast milk. For example, dietary fiber intake has been increasingly reported to benefit the health of the mother-infant dyad. However, the complex interplays among maternal diet, breast milk composition, infant gut microbiota and infant development are yet to be elucidated in a prospective cohort. In addition, the investigators' previous work has revealed unsatisfactory dietary patterns in Hong Kong lactating women, with clear inadequacy in fruit and vegetable intake. In this prospective cohort study, the investigators aim to recruit 100 healthy Chinese mother-child pairs. Data on maternal and infant dietary intake, breast milk composition, gut microbiota profile will be collected and the investigators will examine their associations with the health outcomes in infants. In addition, the influence of dietary factors and genetic predisposition on breast milk components and its associated benefits in the child will be interrogated. With the employment of multidisciplinary research approaches, cutting-edge biotechnologies and the omics platforms, this project will provide novel insights into the dietary factors and breastfeeding practices that are beneficial to the infant developmental trajectory, and the potential roles of breast milk composition in shaping infant's gut microbiota and the associated health impact in the long term. More importantly, the investigators hope to generate more solid scientific data to inform the public of the importance of maternal diet and the practical nutritional strategies to improve breast milk composition for the sake of the child.

Trial Health

57
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 28, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 19, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

3.4 years

First QC Date

February 7, 2022

Last Update Submit

August 5, 2024

Conditions

BreastfeedingInfant Development

Keywords

Early nutritionBreastfeedingInfant growth

Outcome Measures

Primary Outcomes (3)

  • The consumption of dietary fiber in grams by participants

    Dietary fiber intake of lactating women at 1, 3, 6, and 12 month of postpartum assessed by food frequency questionnaire

    through study completion, an average of 1 year

  • Concentration of human milk oligosaccharides, plant-based nutrients and fatty acids in breast milk

    Breast milk composition by analyzing the concentration of human milk oligosaccharides, plant-based nutrients and fatty acids, using Liquid chromatography-mass spectrometry, Triple Quadrupole Mass Spectrometer, UV-Visible detector, flame ionization detector whichever appropriate, in the lactating women's breast milk collected at 3, 6, and 12 months postpartum.

    through study completion, an average of 1 year

  • Microbiota profiles

    Microbiota profiles (microbiome operational taxonomic unit clustering and abundances, the Firmicutes/Bacteroidetes ratios, alpha and beta diversity) at 3, 6, and 12 month old by 16S ribosomal deoxyribonucleic acid sequencing

    through study completion, an average of 1 year

Secondary Outcomes (7)

  • Parameters of infant growth

    through study completion, an average of 1 year

  • Spherical-equivalent error and cylindrical error of infant

    through study completion, an average of 1 year

  • Stereoacuity (sec of arc) of infant

    through study completion, an average of 1 year

  • Spatial frequency threshold of visual acuity of infant

    through study completion, an average of 1 year

  • Ocular deviation (prism diopter) of infant

    through study completion, an average of 1 year

  • +2 more secondary outcomes

Interventions

No intervention is involvedOTHER

No intervention is involved

Eligibility Criteria

Age1 Month - 40 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsthe subjects are mothers and their infants so female subjects needed to be selected while there is no sex limitation in the infants
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

They are Hong Kong lactating women and their infants. Both of them are healthy and intend to continue breastfeeding at least 3 months.

You may qualify if:

  • Hong Kong residents aged 18-40 years old;
  • Vaginal delivery between 37 and 42 weeks of gestation;
  • Carrying a singleton pregnancy;
  • Breastfeeding for \>80% feeding occasions upon recruitment;
  • Intend to continue breastfeeding at least till the infant reaches 3-month old;
  • Delivered between 37 and 42 weeks;
  • Born by vaginal delivery;
  • Singleton infant with no known abnormality;

You may not qualify if:

  • Complicated pregnancy such as preeclampsia and gestational diabetes;
  • Special dietary restrictions for examples gluten-free diets, vegan or any restrictions due to food allergies;
  • Suffer from renal, liver, or thyroid dysfunction, cognitive impairment, or any other indication of a major medical or psychological illness, as judged by the investigators as ineligible to participate the study
  • Have no intention to continue breastfeeding beyond 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

During the interviews at 3rd and 6th month postpartum, each breastfeeding mother will supply a specimen of breast milk in a private interview room. Peripheral venous blood will be collected from mothers at 3rd or 6th month postpartum. Infant urine and feces will be collected on diapers at 3rd, 6th and 12th month visit. Genes that relates to breastmilk secretion including Fucosyltransferase 2 and Fucosyltransferase 3, as well as 16S ribosomal deoxyribonucleic acid sequencing of the infant fecal samples would be determined analyzed from the collected sample.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Man Sau Wong, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wing Wa Ho, bachelor

CONTACT

85234008806wing-wa.ho@polyu.edu.hk

Ka Hei Kenneth Lo, PhD

CONTACT

85234008778kenneth.kh.lo@polyu.edu.hk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 7, 2022

First Posted

February 28, 2022

Study Start

April 19, 2022

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

August 6, 2024

Record last verified: 2024-08

Locations

CN(1)