Stress Clinical Trial
Official title:
Validation of a Proprietary Test Strip for the Detection of Bovine and Soy Proteins in Human Milk: A Randomized Crossover Study
NCT number | NCT04851340 |
Other study ID # | 20-126 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 9, 2020 |
Est. completion date | August 31, 2021 |
Verified date | March 2022 |
Source | University of Idaho |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 7-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 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 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.
Status | Completed |
Enrollment | 38 |
Est. completion date | August 31, 2021 |
Est. primary completion date | July 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Idaho | Moscow | Idaho |
Lead Sponsor | Collaborator |
---|---|
University of Idaho | Free to Feed Inc. |
United States,
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Soy proteins in human milk | This will be measured using a proprietary test strip developed for this purpose. | 4 hours post intervention | |
Primary | Soy proteins in human milk | This will be measured using a proprietary test strip developed for this purpose. | 2 hours post intervention | |
Primary | Bovine proteins in human milk | This will be measured using a proprietary test strip developed for this purpose. | 4 hours post intervention | |
Primary | Bovine proteins in human milk | This will be measured using a proprietary test strip developed for this purpose. | 2 hours post intervention | |
Secondary | Maternal Stress | Measurement of maternal perceived stress levels via the Perceived Stress Scale. The Perceived Stress Scale provides levels of perceived stress on a scale of 0 to 40 with higher scores indicating higher levels of perceived 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. |
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