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Investigating the Detection of Bovine and Soy Proteins in Human Milk

NCT04851340 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-01-24

No results posted yet for this study

Summary

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.

Conditions

  • Microbiome
  • Stress
  • Food Allergy in Infants

Interventions

OTHER

Cow's Milk

Participants will consume 200 mL, 300 mL, and 400 mL of 1% bovine milk during the diet challenge which occurs on three consecutive days of the study. The first day of the diet challenge participants consume 200 mL, the second day 300 mL and the third day 400 mL.

OTHER

Soy Milk

Participants will consume 200 mL, 300 mL, and 400 mL of soy milk during the diet challenge which occurs on three consecutive days of the study. The first day of the diet challenge participants consume 200 mL, the second day 300 mL and the third day 400 mL.

Sponsors & Collaborators

  • Free to Feed Inc.

    collaborator UNKNOWN

  • University of Idaho

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-09
Primary Completion
2021-07-31
Completion
2021-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04851340 on ClinicalTrials.gov