Investigating the Detection of Bovine and Soy Proteins in Human Milk

NCT04851340 | Completed

• 1 other identifier: 20-126
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Food Allergy; Breastfeeding; Maternal Stress; Microbiome

Outcome Measures

Primary Outcomes (4)

• Soy proteins/peptides in human milk

  This will be measured using a proprietary test strip developed for this purpose as well as LC-MS methodology.

  4 hours post intervention

• Soy proteins/peptides in human milk

  This will be measured using a proprietary test strip developed for this purpose as well as LC-MS methodologies.

  2 hours post intervention

• Bovine proteins/peptides in human milk

  This will be measured using a proprietary test strip developed for this purpose and using LC-MS methodologies.

  4 hours post intervention

• Bovine proteins/peptides in human milk

  This will be measured using a proprietary test strip developed for this purpose and using LC-MS methodologies.

  2 hours post intervention

Secondary Outcomes (2)

• Maternal Stress

  Measured at baseline (Day 0) and Days 5, 8, 15, and 18 of the 20-day study. Days 5 and 15 correspond to 5 days post dietary elimination of cow or soy and days 8 and 18 correspond to 3 days post dietary intervention with cow's milk or soy milk.

• Human Milk Microbiome

  Will be assessed on human milk samples collected at baseline (day 0), after the 5-day dietary elmination/run-in periods (days 5,/15), and on the third day of the 3-day dietary intervention periods (days 8/18).

Study Arms (2)

Cow's Milk First

EXPERIMENTAL

Participants in this group will eliminate all cow's milk products during the first 10 days of the study and receive the cow's milk intervention first and then will cross-over to eliminate soy products in the second 10 days of the study and receive the soy milk intervention during the second diet intervention.

Other: Cow's Milk; Other: Soy Milk

Soy Milk First

EXPERIMENTAL

Participants in this group will eliminate all soy products during the first 10 days of the study and receive the soy milk intervention first and then will cross-over to eliminate cow's milk products in the second 10 days of the study and receive the cow's milk intervention during the second diet intervention.

Other: Cow's Milk; Other: Soy Milk

Interventions

Cow's Milk OTHER

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.

Cow's Milk First; Soy Milk First

Soy Milk OTHER

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.

Cow's Milk First; Soy Milk First

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Idaho: lead
• Free to Feed Inc.: collaborator

Study Sites (1)

University of Idaho

Moscow, Idaho, 83844, United States

Location

Related Publications (3)

• Quigley MA, Carson C. Breastfeeding in the 21st century. Lancet. 2016 May 21;387(10033):2087-2088. doi: 10.1016/S0140-6736(16)30534-7. No abstract available.

  PMID: 27301815 BACKGROUND

• Rollins NC, Bhandari N, Hajeebhoy N, Horton S, Lutter CK, Martines JC, Piwoz EG, Richter LM, Victora CG; Lancet Breastfeeding Series Group. Why invest, and what it will take to improve breastfeeding practices? Lancet. 2016 Jan 30;387(10017):491-504. doi: 10.1016/S0140-6736(15)01044-2.

  PMID: 26869576 BACKGROUND

• Partridge CL, Paullin TR, Kim BJ, Dallas DC, Williams JE, McGuire MA, Kaur H, McGuire MK. Detection of bovine milk-, but likely not soy-derived, peptides in human milk after maternal consumption of bovine milk and soy beverage: a randomized, cross-over, dietary intervention trial. Front Nutr. 2025 Oct 23;12:1642177. doi: 10.3389/fnut.2025.1642177. eCollection 2025.

  PMID: 41211220 DERIVED

MeSH Terms

Conditions

Food Hypersensitivity; Breast Feeding

Interventions

Milk; Soy Milk

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages; Milk Substitutes; Soy Foods; Vegetable Products; Vegetables

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Margaret Ritchie School of Family and Consumer Sciences

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: April 20, 2021
• Study Start: November 9, 2020
• Primary Completion: July 31, 2021
• Study Completion: August 31, 2021
• Last Updated: January 24, 2025

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)