Status:
COMPLETED
Study of Nutrition in Postpartum and Early Life Feeding Study
Lead Sponsor:
University of Texas at Austin
Collaborating Sponsors:
National Cattlemen's Beef Association, a contractor to the Beef Checkoff
Conditions:
Glycemic Response
Breast Feeding, Exclusive
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The first few months of life are a critical time for setting the health trajectory of both infants and mothers. It is essential that guidance provided to new families be based on the most rigorous sci...
Detailed Description
During the initial months of life, it is critical to set a path towards a healthy future for both the infant and mother.1-4 It is essential to provide new families with guidance that is grounded in th...
Eligibility Criteria
Inclusion
- Maternal
- Comfortable communicating in English, both orally and in writing
- Infant aged between 6 and 12 weeks at enrollment
- Exclusively breastfeeding one infant
- Intention to continue breastfeeding through duration of the study
- BMI between (18.5 - 29.9) OR BMI 30 - 35 and willing to consume an additional \~240 calories to ensure against caloric deficit
- Willing to consume both meat \& plant-based meat products
- Residing within \~10 mi radius of UT
- Infant
- Exclusively breastfeeding
- Birth weight ≥ 2.5kg (5.5 lbs)
- Maternal
Exclusion
- Pre-gestational diabetes, previous diagnosis of diabetes, or history of GDM (need specific diet)
- Negative delivery outcome (post-delivery stillbirth, infant mortality)
- Began complementary feeding or intends to begin feeding solid food before completion of study, infant age \<16 weeks.
- Active eating disorder (atypical diet quality, anxiety about diet and weight/body measurements and weight gain)
- Active substance abuse with alcohol or drugs by self-report (risk for poor adherence and could impact outcomes)
- Treatment with medications (e.g., corticosteroids, anti-psychotics) known to have metabolic/body weight effects
- BMI \<18.5 or \>35kg/m2
- Unable or unwilling to follow protocol
- Mom following vegetarian, vegan, or strict exclusion diet during pregnancy or lactation
- Excessive caffeine consumer
- Not a good candidate for a feeding trial (In general, if there are a variety of things indicating the potential participant might have a hard time meeting the requirements for the diet intervention. For example, if during screening, the potential participant indicates something that suggests they would be dishonest about their adherence to the diet.)
- Infant
Key Trial Info
Start Date :
October 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06082921
Start Date
October 18 2023
End Date
August 18 2024
Last Update
December 16 2024
Active Locations (1)
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1
University of Texas at Austin - Burgermaster Lab
Austin, Texas, United States, 78705