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Glycemic ResponseSUPERNCT06082921

Study of Nutrition in Postpartum and Early Life Feeding Study

A study testing Beef Diet Intervention and Impossible Beef Diet Intervention in people with Glycemic Response and Breast Feeding, Exclusive, run by University of Texas at Austin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Beef Diet Intervention and Impossible Beef Diet Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
18 Oct 2023to 18 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas at Austin - Burgermaster Lab

    Austin, Texas, 78705

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Beef Diet Intervention, Impossible Beef Diet Intervention
Keywords
feeding trial, breast milk, postpartum, fatty acids, continuous glucose monitor, beef, plant-based meat
Medical subject headings
Breast Feeding, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Beef Diet InterventionBehavioural

    Also called Diet Intervention with Beef

    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 InterventionBehavioural

    Also called Diet Intervention with Impossible Beef

    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.

Study groups in NCT06082921
Study groupRoleWhat they receive
Beef DietExperimentalParticipants 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.
Receives: Behavioral: Beef Diet Intervention
Impossible Beef DietExperimentalParticipants 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.
Receives: Behavioral: Impossible Beef Diet Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Breast Milk Fatty Acid Composition

    Percent composition of fatty acids in breast milk samples during beef diet phase versus plant-based beef diet phase

    Measured: 12 days

  2. Breast Milk Processing Contaminants

    Milk will be analyzed for processing contaminants

    Measured: 12 days

  3. 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

    Measured: 25 days

  4. Glycemic response to beef and impossible beef diet

    Use CGMs to monitor glycemic response during dietary interventions and habitual diet

    Measured: 25 days

Secondary outcomes (2)

  1. 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

    Measured: 25 days

  2. Cytokine composition and percentages in breast milk samples

    Analyze amount of major cytokines present in breast milk samples across diet phases using Bioplex

    Measured: 25 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2023
  2. Study start18 Oct 2023
  3. Primary completion18 Aug 2024
  4. Study completion18 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06082921
Sponsor's protocol ID
00004375
Acronym
SUPER
Status last verified
Dec 2024
First submitted
9 Oct 2023
Last updated
16 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34168507

  • 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.

    PubMed 34968458

  • 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.

    PubMed 36159207

  • 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.

    PubMed 19501316

  • 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.

    PubMed 22378730

  • 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.

    PubMed 30092608

  • 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.

    PubMed 30179726

  • 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.

    PubMed 32767148

  • 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.

    PubMed 36079876

  • 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.

    PubMed 28985033

  • 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.

    PubMed 30243769

  • 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.

    PubMed 31936574

  • 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.

    PubMed 27125637

  • 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.

    PubMed 33296453

  • 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.

    PubMed 36765982

Questions about this trial

What is this clinical trial studying?

A study testing Beef Diet Intervention and Impossible Beef Diet Intervention in people with Glycemic Response and Breast Feeding, Exclusive, run by University of Texas at Austin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Breast Milk Fatty Acid Composition (time frame: 12 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06082921, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.

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