Investigating the Detection of Bovine and Soy Proteins in Human Milk
Completed · Not applicable
Conditions studied: Microbiome, Stress, Food Allergy in Infants
In brief
This study is a randomized, cross-over, dietary intervention research design comprising a 5-day run-in period, two 3-day dietary interventions, and a 2-day washout period. Participants (mother-offspring dyads) will be randomly assigned to order of interventions. Participants will be recruited as a convenience sample from mother-offspring dyads in the greater Moscow, Idaho and Boise, Idaho areas. The initial purpose of this study is to to learn more about the use of an allergen test strip to detect cow's milk and soy food allergen proteins in human milk, to identify soy and bovine-derived peptides in human milk after consumption of these foods, to explore the impact of maternal bovine milk and soy milk consumption on human milk and maternal/infant gastrointestinal microbiomes and to examine maternal stress during periods of dietary elimination and re-introductions periods.
Key facts
- Study ID
- NCT04851340
- Run by
- University of Idaho
- People needed
- 38
- Starts
- 2020-11-09
- Expected to finish
- 2021-08-31
- Last updated by the study team
- 2025-01-24
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Healthy women aged 18 years or older
- Ability to drive to Boise, Idaho or Moscow, Idaho or New York, New York
- Must be currently lactating or breastfeeding
- Mothers of infants aged 0-12 months
- Willing to provide samples of human milk
- Willing to consume 1-2 cups of soy milk and cow's milk daily for 3 days each
You may not qualify if…
- Individuals who are unable or unwilling to consume bovine or soy milk
- Individuals unwilling or unable to provide samples of human milk
- Individuals unable to speak and read English
Where it is running
- University of Idaho — Moscow, Idaho, United States
Full record on ClinicalTrials.gov
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