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Study of Nutrition in Postpartum and Early Life Feeding Study

Study of nUtrition in Postpartum and EaRly Life (SUPER): Beef Feeding Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06082921
Acronym
SUPER
Enrollment
24
Registered
2023-10-13
Start date
2023-10-18
Completion date
2024-08-18
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Feeding, Exclusive, Eating Behavior, Glycemic Response

Keywords

feeding trial, breast milk, postpartum, fatty acids, continuous glucose monitor, beef, plant-based meat

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 scientific evidence available. Beef serves as a highly nutrient-rich option for lactating women. Plant-based beef products have similar nutrient profiles, and some consumers perceive them as a healthier alternative to traditional beef. This study aims to understand the different effects that beef and plant-based beef have on breastmilk composition, maternal glycemic control, maternal intake and satiety, and infant intake. Understanding the differences between beef and plant-based beef can help parents make informed decisions about optimal nutrition for their infants and themselves.

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 the most rigorous scientific evidence possible. Although beef is a highly nutritious option for lactating women, there are now many plant-based beef products with similar nutrient profiles. Some consumers consider these substitutes to be a healthier alternative to beef. 5 Plant-based meat alternatives have become a common component of many Americans diets.5 A controlled trial is necessary to explore differences between beef and plant-based beef. There have been no trials to establish differences in biochemical compounds available to breastfeeding infants in human milk based on lactating mothers' consumption of meat vs. plant-based meat. Furthermore, the amounts of compounds related to plant-based meat analogues that are transferred from a mother's diet into her breastmilk have also not been examined. While maternal weight status is increasingly linked to milk composition and differences in infant weight status,6-9 the role of diet in these associations has not been studied. These differences in breastmilk composition related to infant weight could explain inconsistent influence of breastfeeding on later weight status. Identifying possible biomarkers transferred from mothers to infants in breastmilk would elucidate potential biological mechanisms to explain the diet-weight relationship. Finally, while some studies have linked metabolic dysregulation such as obesity or diabetes to negative alterations in breastmilk composition,3,7,10-13 we are not aware of any studies that consider whether the deleterious effects are attributable to glycemic control. Differences in ingredients and processing could lead to a differential effect on glycemic response in meat vs. plant-based meat.14-17 Such a finding would contribute to understanding the mechanisms by which maternal postnatal health and diet influence infant development. This pilot study will help plan for future studies related to this population.

Interventions

BEHAVIORALBeef Diet Intervention

Participants will eat prepared meals including beef for 6 days. Participants will eat a habitual diet for 6 days prior to intervention.

BEHAVIORALImpossible Beef Diet Intervention

Participants will eat prepared meals including impossible beef for one portion 6 days. Participants will eat a habitual diet for 6 days prior to intervention.

Sponsors

National Cattlemen's Beef Association, a contractor to the Beef Checkoff
CollaboratorINDUSTRY
University of Texas at Austin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Maternal Inclusion Criteria: 1. Comfortable communicating in English, both orally and in writing 2. Infant aged between 6 and 12 weeks at enrollment 3. Exclusively breastfeeding one infant 4. Intention to continue breastfeeding through duration of the study 5. BMI between (18.5 - 29.9) OR BMI 30 - 35 and willing to consume an additional \ 240 calories to ensure against caloric deficit 6. Willing to consume both meat & plant-based meat products 7. Residing within \ 10 mi radius of UT Infant Inclusion Criteria: 1. Exclusively breastfeeding 2. Birth weight ≥ 2.5kg (5.5 lbs) Maternal

Exclusion criteria

1. Pre-gestational diabetes, previous diagnosis of diabetes, or history of GDM (need specific diet) 2. Negative delivery outcome (post-delivery stillbirth, infant mortality) 3. Began complementary feeding or intends to begin feeding solid food before completion of study, infant age \<16 weeks. 4. Active eating disorder (atypical diet quality, anxiety about diet and weight/body measurements and weight gain) 5. Active substance abuse with alcohol or drugs by self-report (risk for poor adherence and could impact outcomes) 6. Treatment with medications (e.g., corticosteroids, anti-psychotics) known to have metabolic/body weight effects 7. BMI \<18.5 or \>35kg/m2 8. Unable or unwilling to follow protocol 9. Mom following vegetarian, vegan, or strict exclusion diet during pregnancy or lactation 10. Excessive caffeine consumer 11. 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

Design outcomes

Primary

MeasureTime frameDescription
Breast Milk Fatty Acid Composition12 daysPercent composition of fatty acids in breast milk samples during beef diet phase versus plant-based beef diet phase
Breast Milk Processing Contaminants12 daysMilk will be analyzed for processing contaminants
Differences in Intake25 daysAssess differences in intake using maternal consumption measured by food record, maternal satiety measured by survey, and maternal weight change measured at baseline and end of each condition; infant intake measured by weighed feeding
Glycemic response to beef and impossible beef diet25 daysUse CGMs to monitor glycemic response during dietary interventions and habitual diet

Secondary

MeasureTime frameDescription
Relationship between glycemic response and breastmilk composition25 daysDetermine if elevated glycemic response alters breastmilk composition by comparing hormones in breastmilk to data collected from CGMs
Cytokine composition and percentages in breast milk samples25 daysAnalyze amount of major cytokines present in breast milk samples across diet phases using Bioplex

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026