Study of Nutrition in Postpartum and Early Life Feeding Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Glycemic Response, Breast Feeding, Exclusive, Eating Behavior

Intervention / Treatment
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* Behavioral: Beef Diet Intervention
* Behavioral: Impossible Beef Diet Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 18.5 - 29.9 kg/m2 at enrollment Willing to consume both meat & plant-based meat products Residing within  10 mi radius of UT Exclusion Criteria: Pre-gestational diabetes, previous diagnosis of diabetes, or history of GDM (need specific diet) Negative delivery outcome (post-delivery stillbirth, infant mortality, NICU or ICU required) 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 >=30kg/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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beef Diet<br>Participants will eat 3 chef prepared meals a day that contain beef as main protein source. Snacks and desserts will be provided. All aspects of the meals, except for meat type (beef/impossible beef) will be the same during each arm. The base diet will be comprised of whole foods. Meals will meet acceptable macronutrient distribution ranges of the USDA. | Behavioral: Beef Diet Intervention<br>* Participants will eat prepared meals including beef for 6 days. Participants will eat a habitual diet for 6 days prior to intervention.<br>* Other names: Diet Intervention with Beef;|
| Experimental: Impossible Beef Diet<br>Participants will eat 3 chef prepared meals a day that contain impossible beef as main protein source. Snacks and desserts will be provided. All aspects of the meals, except for meat type (beef/impossible beef) will be the same during each arm. The base diet will be comprised of whole foods. Meals will meet acceptable macronutrient distribution ranges of the USDA. | Behavioral: Impossible Beef Diet Intervention<br>* 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.<br>* Other names: Diet Intervention with Impossible Beef;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast Milk Fatty Acid Composition | Percent composition of fatty acids in breast milk samples during beef diet phase versus plant-based beef diet phase | 12 days | 
| Breast Milk Processing Contaminants | Milk will be analyzed for processing contaminants | 12 days | 
| Differences in Intake | Assess 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 | 25 days | 
| Glycemic response to beef and impossible beef diet | Use CGMs to monitor glycemic response during dietary interventions and habitual diet | 25 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between glycemic response and breastmilk composition | Determine if elevated glycemic response alters breastmilk composition by comparing hormones in breastmilk to data collected from CGMs | 25 days | 
| Cytokine composition and percentages in breast milk samples | Analyze amount of major cytokines present in breast milk samples across diet phases using Bioplex | 25 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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feeding trial, breast milk, postpartum, fatty acids, continuous glucose monitor, beef, plant-based meat