Study of Nutrition in Postpartum and Early Life Feeding Study (SUPER)

May 6, 2024 updated by: University of Texas at Austin

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • University of Texas at Austin - Burgermaster Lab
        • Contact:
          • Marissa Burgermaster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Exclusion Criteria:

  1. Preterm or in NICU post birth for >72 hours
  2. Low birth weight < 2.5 kg
  3. Negative health outcome following delivery that could affect breast feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Beef Diet
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
Participants will eat prepared meals including beef for 6 days. Participants will eat a habitual diet for 6 days prior to intervention.
Other Names:
  • Diet Intervention with Beef
Experimental: Impossible Beef Diet
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
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.
Other Names:
  • Diet Intervention with Impossible Beef

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breast Milk Fatty Acid Composition
Time Frame: 12 days
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
Time Frame: 12 days
Milk will be analyzed for processing contaminants
12 days
Differences in Intake
Time Frame: 25 days
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
Time Frame: 25 days
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
Time Frame: 25 days
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
Time Frame: 25 days
Analyze amount of major cytokines present in breast milk samples across diet phases using Bioplex
25 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Collaborators

National Cattlemen's Beef Association

Investigators

  • Principal Investigator: Marissa Burgermaster, PhD, University of Texas at Austin
  • Principal Investigator: Tom Brenna, PhD, University of Texas at Austin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

October 9, 2023

First Submitted That Met QC Criteria

October 9, 2023

First Posted (Actual)

October 13, 2023

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 00004375

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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