What side effects are associated with this type of intervention?

Common treatments for glycemic responses include dietary modifications such as high-protein, low-carbohydrate diets, and the inclusion of specific foods like almonds and soy. High-protein, low-carbohydrate diets can lead to side effects such as increased risk of nutrient deficiencies, constipation, and potential cardiovascular issues due to high fat intake. Almond-based diets are generally well-tolerated but may cause gastrointestinal discomfort in some individuals. Soy consumption is usually safe but can lead to mild digestive issues and, in rare cases, allergic reactions. These dietary approaches aim to improve glycemic control but should be tailored to individual needs and monitored by healthcare professionals.

What prior FDA approvals exist?

The FDA has approved various treatments for managing glycemic responses in diabetes patients. These include insulin therapies such as long-acting insulin (e.g., insulin glargine) and premixed insulin formulations, which help regulate blood glucose levels. Oral hypoglycemic agents like metformin, sulfonylureas, and DPP-4 inhibitors are also commonly used. Additionally, dietary interventions, such as the Mediterranean diet and carbohydrate counting, are recommended to improve glycemic control. These treatments aim to maintain stable blood glucose levels and reduce the risk of diabetes-related complications.

What other types of research exist?

Promising alternatives to beef and plant-based beef for glycemic responses include foods high in specific types of dietary fibers, such as wheat bran and citrus pectin, which have shown hypoglycemic and hypocholesterolemic effects, respectively. Additionally, incorporating barley into the diet may help manage blood glucose levels due to its beneficial properties observed in diabetic states. These alternatives can be considered for their potential to improve glycemic control and overall metabolic health.

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

N/A

Recruiting

Led By Tom Brenna, 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

Select...

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 25 days

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.

0 / 3Eligibility criteria met

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.