- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05133466
Odour Characteristics of Human Breast Milk of Chinese Mothers
12. november 2021 opdateret af: Heilongjiang Feihe Dairy Co. Ltd.
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.
Studieoversigt
Status
Rekruttering
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Forventet)
90
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Han Sun, M.S.
- Telefonnummer: +86 010-84574688
- E-mail: sunhan@feihe.com
Studiesteder
-
-
Beijing
-
Peking, Beijing, Kina, 100191
- Rekruttering
- Peking University Health Science Center
-
Kontakt:
- Han Sun, M.S.
- Telefonnummer: +86 010-84574688
- E-mail: sunhan@feihe.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
25 år til 35 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Healthy lactating mothers (aged 25-35 years) who breast-feed their infants (aged 15-180 days).
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Northern pattern
Mothers recruited from Beijing
|
|
East coastal pattern
Mothers recruited from Wuxi
|
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South-western pattern
Mothers recruited from Chengdu
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Odour active compound and their concentrations
Tidsramme: 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.
|
Up to 2 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
20. september 2021
Primær færdiggørelse (Forventet)
1. september 2022
Studieafslutning (Forventet)
1. september 2023
Datoer for studieregistrering
Først indsendt
25. oktober 2021
Først indsendt, der opfyldte QC-kriterier
12. november 2021
Først opslået (Faktiske)
24. november 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. november 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. november 2021
Sidst verificeret
1. november 2021
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2021-FEIHE-BTBU-001
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
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Ingen
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