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Beef Diet and Impossible Beef Diet for Postpartum and Early Life Feeding (SUPER Trial)

N/A
Recruiting
Led By Marissa Burgermaster, PhD
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Infant aged between 6 and 12 weeks at enrollment
Be older than 18 years old
Must not have
Pre-gestational diabetes, previous diagnosis of diabetes, or history of GDM (need specific diet)
Unable or unwilling to follow protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 25 days
Awards & highlights
No Placebo-Only Group

Summary

This trial compares the effects of regular beef and plant-based beef on breastfeeding mothers and their babies. It aims to see if these diets affect breastmilk nutrients, maternal health, and infant nutrition differently.

Who is the study for?
This study is for new mothers who are exclusively breastfeeding infants aged 6-12 weeks, have a BMI of 18.5-29.9, and live near the University of Texas. They must be willing to eat both meat and plant-based meat products but cannot have diabetes, an eating disorder, or substance abuse issues.
What is being tested?
The trial examines how a diet including beef versus plant-based 'beef' affects breastmilk composition, maternal blood sugar control, satiety levels in mothers and their babies' intake during early life.
What are the potential side effects?
While not explicitly stated in the provided information, potential side effects may include changes in digestive comfort due to dietary adjustments or allergic reactions if participants have unknown food sensitivities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My baby is between 6 and 12 weeks old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have diabetes or had gestational diabetes and follow a specific diet.
Select...
I am willing and able to follow the study's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~25 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 25 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Breast Milk Fatty Acid Composition
Breast Milk Processing Contaminants
Differences in Intake
+1 more
Secondary study objectives
Cytokine composition and percentages in breast milk samples
Relationship between glycemic response and breastmilk composition

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Impossible Beef DietExperimental Treatment1 Intervention
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.
Group II: Beef DietExperimental Treatment1 Intervention
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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for managing glycemic responses in patients with type 2 diabetes include dietary interventions such as the Mediterranean diet, low-carbohydrate diets, and the inclusion of specific foods like almonds. These treatments work by improving insulin sensitivity, reducing postprandial glucose levels, and promoting a balanced intake of macronutrients. For example, the Mediterranean diet, rich in vegetables and healthy fats, has been shown to improve glycemic control and reduce the risk of diabetes-related complications. Similarly, low-carbohydrate diets can help lower blood glucose levels by reducing the intake of high-glycemic index foods. Including foods like almonds, which have a low glycemic index and high fiber content, can further aid in stabilizing blood sugar levels. Understanding these mechanisms is crucial for patients as it helps them make informed dietary choices that can effectively manage their blood glucose levels and improve overall health.
The Effects of Almonds on Gut Microbiota, Glycometabolism, and Inflammatory Markers in Patients with Type 2 Diabetes: A Systematic Review and Meta-Analysis of Randomised Controlled Trials.The use of combined high-fructose diet and glyphosate to model rats type 2 diabetes symptomatology.Efficacy and risk profile of anti-diabetic therapies: Conventional vs traditional drugs-A mechanistic revisit to understand their mode of action.

Find a Location

Who is running the clinical trial?

National Cattlemen's Beef AssociationOTHER
24 Previous Clinical Trials
1,064 Total Patients Enrolled
University of Texas at AustinLead Sponsor
372 Previous Clinical Trials
84,019 Total Patients Enrolled
Marissa Burgermaster, PhDPrincipal InvestigatorUniversity of Texas at Austin
2 Previous Clinical Trials
140 Total Patients Enrolled
~10 spots leftby Oct 2025
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