Study of Nutrition in Postpartum and Early Life Feeding Study

NCT06082921 | Completed

• 1 other identifier: 00004375
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Glycemic Response; Breast Feeding, Exclusive; Eating Behavior

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Relationship between glycemic response and breastmilk composition

  25 days

• Cytokine composition and percentages in breast milk samples

  25 days

Study Arms (2)

Beef Diet

EXPERIMENTAL

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

Impossible Beef Diet

EXPERIMENTAL

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

Interventions

Beef Diet Intervention BEHAVIORAL

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

Also known as: Diet Intervention with Beef

Beef Diet

Impossible Beef Diet Intervention BEHAVIORAL

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.

Also known as: Diet Intervention with Impossible Beef

Impossible Beef Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Exclusively breastfeeding
• Birth weight ≥ 2.5kg (5.5 lbs)

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas at Austin: lead
• National Cattlemen's Beef Association, a contractor to the Beef Checkoff: collaborator

Study Sites (1)

University of Texas at Austin - Burgermaster Lab

Austin, Texas, 78705, United States

Location

Related Publications (17)

• Tinius RA, Yoho K, Blankenship MM, Maples JM. Postpartum Metabolism: How Does It Change from Pregnancy and What are the Potential Implications? Int J Womens Health. 2021 Jun 17;13:591-599. doi: 10.2147/IJWH.S314469. eCollection 2021.

  PMID: 34168507 BACKGROUND

• Marshall NE, Abrams B, Barbour LA, Catalano P, Christian P, Friedman JE, Hay WW Jr, Hernandez TL, Krebs NF, Oken E, Purnell JQ, Roberts JM, Soltani H, Wallace J, Thornburg KL. The importance of nutrition in pregnancy and lactation: lifelong consequences. Am J Obstet Gynecol. 2022 May;226(5):607-632. doi: 10.1016/j.ajog.2021.12.035. Epub 2021 Dec 27.

  PMID: 34968458 BACKGROUND

• Choi E, Kazzi B, Varma B, Ortengren AR, Minhas AS, Vaught AJ, Bennett WL, Lewey J, Michos ED. The Fourth Trimester: a Time for Enhancing Transitions in Cardiovascular Care. Curr Cardiovasc Risk Rep. 2022;16(12):219-229. doi: 10.1007/s12170-022-00706-x. Epub 2022 Sep 21.

  PMID: 36159207 BACKGROUND

• Gunderson EP. Childbearing and obesity in women: weight before, during, and after pregnancy. Obstet Gynecol Clin North Am. 2009 Jun;36(2):317-32, ix. doi: 10.1016/j.ogc.2009.04.001.

  PMID: 19501316 BACKGROUND

• Ley SH, Hanley AJ, Sermer M, Zinman B, O'Connor DL. Associations of prenatal metabolic abnormalities with insulin and adiponectin concentrations in human milk. Am J Clin Nutr. 2012 Apr;95(4):867-74. doi: 10.3945/ajcn.111.028431. Epub 2012 Feb 29.

  PMID: 22378730 BACKGROUND

• Young BE, Levek C, Reynolds RM, Rudolph MC, MacLean P, Hernandez TL, Friedman JE, Krebs NF. Bioactive components in human milk are differentially associated with rates of lean and fat mass deposition in infants of mothers with normal vs. elevated BMI. Pediatr Obes. 2018 Oct;13(10):598-606. doi: 10.1111/ijpo.12394. Epub 2018 Aug 9.

  PMID: 30092608 BACKGROUND

• Gomes RM, Bueno FG, Schamber CR, de Mello JCP, de Oliveira JC, Francisco FA, Moreira VM, Junior MDF, Pedrino GR, de Freitas Mathias PC, Miranda RA, de Moraes SMF, Natali MRM. Maternal diet-induced obesity during suckling period programs offspring obese phenotype and hypothalamic leptin/insulin resistance. J Nutr Biochem. 2018 Nov;61:24-32. doi: 10.1016/j.jnutbio.2018.07.006. Epub 2018 Jul 25.

  PMID: 30179726 BACKGROUND

• Rughani A, Friedman JE, Tryggestad JB. Type 2 Diabetes in Youth: the Role of Early Life Exposures. Curr Diab Rep. 2020 Aug 7;20(9):45. doi: 10.1007/s11892-020-01328-6.

  PMID: 32767148 BACKGROUND

• Suwaydi MA, Zhou X, Perrella SL, Wlodek ME, Lai CT, Gridneva Z, Geddes DT. The Impact of Gestational Diabetes Mellitus on Human Milk Metabolic Hormones: A Systematic Review. Nutrients. 2022 Sep 1;14(17):3620. doi: 10.3390/nu14173620.

  PMID: 36079876 BACKGROUND

• Whitaker KM, Marino RC, Haapala JL, Foster L, Smith KD, Teague AM, Jacobs DR, Fontaine PL, McGovern PM, Schoenfuss TC, Harnack L, Fields DA, Demerath EW. Associations of Maternal Weight Status Before, During, and After Pregnancy with Inflammatory Markers in Breast Milk. Obesity (Silver Spring). 2017 Dec;25(12):2092-2099. doi: 10.1002/oby.22025. Epub 2017 Oct 6.

  PMID: 28985033 BACKGROUND

• Ramos-Roman MA. Breast Milk: A Postnatal Link Between Maternal Life Choices and the Prevention of Childhood Obesity. Clin Ther. 2018 Oct;40(10):1655-1658. doi: 10.1016/j.clinthera.2018.08.018. Epub 2018 Sep 20.

  PMID: 30243769 BACKGROUND

• Peila C, Gazzolo D, Bertino E, Cresi F, Coscia A. Influence of Diabetes during Pregnancy on Human Milk Composition. Nutrients. 2020 Jan 9;12(1):185. doi: 10.3390/nu12010185.

  PMID: 31936574 BACKGROUND

• Fardet A. Minimally processed foods are more satiating and less hyperglycemic than ultra-processed foods: a preliminary study with 98 ready-to-eat foods. Food Funct. 2016 May 18;7(5):2338-46. doi: 10.1039/c6fo00107f. Epub 2016 Apr 29.

  PMID: 27125637 BACKGROUND

• Musa-Veloso K, Noori D, Venditti C, Poon T, Johnson J, Harkness LS, O'Shea M, Chu Y. A Systematic Review and Meta-Analysis of Randomized Controlled Trials on the Effects of Oats and Oat Processing on Postprandial Blood Glucose and Insulin Responses. J Nutr. 2021 Feb 1;151(2):341-351. doi: 10.1093/jn/nxaa349.

  PMID: 33296453 BACKGROUND

• Shkembi B, Huppertz T. Glycemic Responses of Milk and Plant-Based Drinks: Food Matrix Effects. Foods. 2023 Jan 18;12(3):453. doi: 10.3390/foods12030453.

  PMID: 36765982 BACKGROUND

• Shimamura Y, Inagaki R, Oike M, Dong B, Gong W, Masuda S. Glycidol Fatty Acid Ester and 3-Monochloropropane-1,2-Diol Fatty Acid Ester in Commercially Prepared Foods. Foods. 2021 Nov 24;10(12):2905. doi: 10.3390/foods10122905.

  PMID: 34945456 BACKGROUND

• Messer S, Hudson E, Rosenthal M, Leidy H, Li YN, Brenna JT, Park HG, Dahale N, Kan L, Mai JL, Widen EM, Harper L, Cooper MH, Burgermaster M. The effect of consuming diets containing beef compared with plant-based beef substitute on human milk composition in the study of nutrition in postpartum and early-life (SUPER) randomized crossover feeding trial. Am J Clin Nutr. 2025 Nov 13:101108. doi: 10.1016/j.ajcnut.2025.11.001. Online ahead of print.

  PMID: 41241005 DERIVED

Related Links

• Boukid F. Plant-based meat analogues: from niche to mainstream. Eur Food Res Technol. 2021;247(2):297-308. doi:10.1007/s00217-020-03630-9

MeSH Terms

Conditions

Breast Feeding; Feeding Behavior

Interventions

Red Meat

Condition Hierarchy (Ancestors)

Behavior; Behavior, Animal

Intervention Hierarchy (Ancestors)

Meat; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Marissa Burgermaster, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

• Tom Brenna, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 13, 2023
• Study Start: October 18, 2023
• Primary Completion: August 18, 2024
• Study Completion: August 18, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)