Odour Characteristics of Human Breast Milk of Chinese Mothers

Sponsor
Heilongjiang Feihe Dairy Co. Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05133466
Collaborator
(none)
90
1
23.4
3.9

Study Details

Study Description

Brief Summary

It is well known that breast milk exerts many positive effects on the general health, growth and development of infants. When breastfeeding is not possible, infant formula is considered to be an effective substitute to satisfy the regular nutritional demand of infants. At present, researchers make every effort to simulate the nutritional status of breast milk but mostly neglect the important role that odour plays in guiding the baby to recognize breast milk, promoting the baby's sucking behavior and food intake. The odour changes of the breast milk are so far mainly related to storage, lactational stage and maternal diet. To understand the odour characteristics of the human breast milk from different regions in China, 90 mothers will be recruited from three Chinese cities: Beijing, Chengdu and Wuxi, representing three typical regions with very different climate characteristics and diet habits. The breast milk samples as well as infant formulas will be analyzed using the identical state of the art separation and identification techniques to identify the odorous compounds, determine their concentrations in the breast milk and infant formula as well as determine their importance in contributing to the total odour of samples. The final objective of this study will be to mimic the odour of the breast milk and to understand the difference of breast milk odour from different regions with very different climate and diet composition, as well as to identify the odour deviation of the infant formula from the breast milk. Our results will provide references for the preparation of new infant formula with both nutritional ingredents and odour characteristics simulating that of breast milk.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    90 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Odour Characteristics of Human Breast Milk of Chinese Mothers
    Actual Study Start Date :
    Sep 20, 2021
    Anticipated Primary Completion Date :
    Sep 1, 2022
    Anticipated Study Completion Date :
    Sep 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Northern pattern

    Mothers recruited from Beijing

    East coastal pattern

    Mothers recruited from Wuxi

    South-western pattern

    Mothers recruited from Chengdu

    Outcome Measures

    Primary Outcome Measures

    1. Odour active compound and their concentrations [Up to 2 years]

      Gas chromatography-olfactometry/mass spectrometry and other state of the art equipments and protocols will be employed to identify the odour active compounds in the samples, and their concentration and importance in contributing to the odour will be determined.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Lactating mother aged 25 ~ 35 years

    • Breastfeeding infants (aged 15 ~180 days) and express sufficient breast milk

    • Mother is in good health and has balanced nutrition

    • Mother is non smoker and non alcoholic, no smokers living in the same apartment

    • Voluntarily signed the Informed Consent Form

    Exclusion Criteria:
    • Mother or newborn infant has major diseases

    • Mother participating in any other nutritional or pharmaceutical intervention studies recently

    • Other conditions that are not suitable for this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University Health Science Center Peking Beijing China 100191

    Sponsors and Collaborators

    • Heilongjiang Feihe Dairy Co. Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Heilongjiang Feihe Dairy Co. Ltd.
    ClinicalTrials.gov Identifier:
    NCT05133466
    Other Study ID Numbers:
    • 2021-FEIHE-BTBU-001
    First Posted:
    Nov 24, 2021
    Last Update Posted:
    Nov 24, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 24, 2021