Evolutionary and Sociocultural Aspects of Human Milk Composition

NCT ID: NCT02670278

Last Updated: 2016-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

960 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Brief Summary

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It is well-known that breastfeeding protects infants from illness, especially in the poorest regions of the world. The full nature of this protective effect, however, is less well understood. A major barrier to understanding is the fact that almost nothing is known about the factors that influence the considerable variation in milk composition around the globe, or about the effects of this variation on infant health. This INSPIRE project represents the first comprehensive investigation of the global differences in human milk composition along with the various microbial, evolutionary, environmental, and sociocultural factors that might influence both milk composition and infant health. An international, interdisciplinary collaboration of physiologists, nutritional scientists, anthropologists, microbiologists, and mathematicians will collect biological data from breastfeeding women and their infants, in concert with extensive anthropologic and ecological data, in both developed (US, Spain, Sweden) and developing countries (Central African Republic, Gambia, Ghana, Peru, and Kenya). To test the possibility of a correlation between milk oligosaccharide composition, milk microbiota, and the gastrointestinal microbiome of infants, milk samples and infant fecal samples will be analyzed using state-of-the-art biochemical and genomic techniques. This study will allow important cross-cultural comparisons of milk composition and infant feeding practices; it also will utilize sophisticated computational methods to integrate the extensive, diverse body of combined biological and anthropological data to elucidate the relationships among sociocultural factors, evolutionary history, environmental exposures, microbial constituents and milk composition. The researchers predict that what is considered "normal" milk composition in one population may not support optimal health in another. This information is crucial to the humanitarian quest to understand how infant nutrition and overall health can be improved around the world. In addition, this project will provide extensive research training opportunities for undergraduate, graduate and postdoctoral scientists.

Detailed Description

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Conditions

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Breast Milk Collection

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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US-Washington, Idaho

healthy breastfeeding women and their infants

No interventions assigned to this group

US-California

healthy breastfeeding women and their infants

No interventions assigned to this group

Sweden

healthy breastfeeding women and their infants

No interventions assigned to this group

Spain

healthy breastfeeding women and their infants

No interventions assigned to this group

Peru

healthy breastfeeding women and their infants

No interventions assigned to this group

Kenya

healthy breastfeeding women and their infants

No interventions assigned to this group

Ethiopia-rural

healthy breastfeeding women and their infants

No interventions assigned to this group

Ethiopia-urban

healthy breastfeeding women and their infants

No interventions assigned to this group

The Gambia-rural

healthy breastfeeding women and their infants

No interventions assigned to this group

The Gambia-urban

healthy breastfeeding women and their infants

No interventions assigned to this group

Ghana

healthy breastfeeding women and their infants

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Breastfeeding or pumping at least 5 times daily (to assure adequate milk production)
* Self-reported healthy women and infants
* ≥ 18 yr of age (maternal)
* 1-3 mo postpartum

Exclusion Criteria

* Current indication of breast infection (e.g., breast pain, discomfort, lumps, mastitis with fever, red streaks, or hard red portions of the breast)
* Breast pain that the woman does not consider "normal" for lactation/breastfeeding
* Any antibiotics to mother or infant in the previous month (30 days)
* Infant has had signs/symptoms of acute illness in the previous 7 days including the following: fever, diarrhea (≥ 3 excessively "loose" stools in a day), vomiting not associated with feeding, severe cough, rapid breathing
Minimum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle K McGuire, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington State University

Locations

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School of Biological Sciences

Pullman, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michelle K McGuire, PhD

Role: CONTACT

208-596-5032

Mark A McGuire, PhD

Role: CONTACT

208-301-2334

Facility Contacts

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Michelle McGuire, PhE

Role: primary

References

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Ruiz L, Alba C, Garcia-Carral C, Jimenez EA, Lackey KA, McGuire MK, Meehan CL, Foster J, Sellen DW, Kamau-Mbuthia EW, Kamundia EW, Mbugua S, Moore SE, Prentice AM, Gindola K D, Otoo GE, Pareja RG, Bode L, McGuire MA, Williams JE, Rodriguez JM. Comparison of Two Approaches for the Metataxonomic Analysis of the Human Milk Microbiome. Front Cell Infect Microbiol. 2021 Mar 25;11:622550. doi: 10.3389/fcimb.2021.622550. eCollection 2021.

Reference Type DERIVED
PMID: 33842385 (View on PubMed)

Ruiz L, Espinosa-Martos I, Garcia-Carral C, Manzano S, McGuire MK, Meehan CL, McGuire MA, Williams JE, Foster J, Sellen DW, Kamau-Mbuthia EW, Kamundia EW, Mbugua S, Moore SE, Kvist LJ, Otoo GE, Lackey KA, Flores K, Pareja RG, Bode L, Rodriguez JM. What's Normal? Immune Profiling of Human Milk from Healthy Women Living in Different Geographical and Socioeconomic Settings. Front Immunol. 2017 Jun 30;8:696. doi: 10.3389/fimmu.2017.00696. eCollection 2017.

Reference Type DERIVED
PMID: 28713365 (View on PubMed)

McGuire MK, Meehan CL, McGuire MA, Williams JE, Foster J, Sellen DW, Kamau-Mbuthia EW, Kamundia EW, Mbugua S, Moore SE, Prentice AM, Kvist LJ, Otoo GE, Brooker SL, Price WJ, Shafii B, Placek C, Lackey KA, Robertson B, Manzano S, Ruiz L, Rodriguez JM, Pareja RG, Bode L. What's normal? Oligosaccharide concentrations and profiles in milk produced by healthy women vary geographically. Am J Clin Nutr. 2017 May;105(5):1086-1100. doi: 10.3945/ajcn.116.139980. Epub 2017 Mar 29.

Reference Type DERIVED
PMID: 28356278 (View on PubMed)

McGuire MK, McGuire MA, Price WJ, Shafii B, Carrothers JM, Lackey KA, Goldstein DA, Jensen PK, Vicini JL. Glyphosate and aminomethylphosphonic acid are not detectable in human milk. Am J Clin Nutr. 2016 May;103(5):1285-90. doi: 10.3945/ajcn.115.126854. Epub 2016 Mar 30.

Reference Type DERIVED
PMID: 27030536 (View on PubMed)

Other Identifiers

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24300409

Identifier Type: -

Identifier Source: org_study_id

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