Odour Characteristics of Human Breast Milk of Chinese Mothers

Breast Milk Collection Clinical Trial

Official title:

Odour Characteristics of Human Breast Milk of Chinese Mothers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05133466
• Other study ID #: 2021-FEIHE-BTBU-001
• Status: Recruiting
• Start date: September 20, 2021
• Est. completion date: September 2023

Study information

• Verified date: November 2021
• Source: Heilongjiang Feihe Dairy Co. Ltd.
• Contact: Han Sun, M.S.
• Phone: +86 010-84574688
• Email: sunhan[@]feihe.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 2023
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Milk Collection

Locations

Country	Name	City	State
China	Peking University Health Science Center	Peking	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Heilongjiang Feihe Dairy Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Odour active compound and their concentrations	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.	Up to 2 years