Study of Nutrition in Postpartum and Early Life Feeding Study

Eating Behavior Clinical Trial

— SUPER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06082921
• Other study ID #: 00004375
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: May 2024
• Source: University of Texas at Austin
• Contact: Sr. Research Program Coordinator
• Phone: 512-495-4715
• Email: burgermasterlab[@]austin.utexas.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 1, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Feeding, Exclusive
• Eating Behavior
• Glycemic Response

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Texas at Austin - Burgermaster Lab	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas at Austin	National Cattlemen's Beef Association

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Obesity (Silver Spring). 2018 Oct;26(10):1659-1660. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Breast Milk Processing Contaminants	Milk will be analyzed for processing contaminants	12 days
Primary	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
Primary	Glycemic response to beef and impossible beef diet	Use CGMs to monitor glycemic response during dietary interventions and habitual diet	25 days
Secondary	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
Secondary	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

External 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