Dietary Patterns for Prediabetes

Overseen By Stephanie Recker

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: National Cattlemen's Beef Association, a contractor to the Beef Checkoff

Disqualifiers: Pregnancy, Diabetes, Thyroid disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how different dietary patterns affect inflammation and other health markers in people with prediabetes or metabolic syndrome. Participants will follow one of two diets: a healthy beef-centric diet, focusing on beef as the main protein, or a healthy U.S.-style diet based on balanced guidelines, including fruits and vegetables. The trial seeks individuals with prediabetes or metabolic syndrome, a large waistline, high blood pressure, and regular beef consumption. As an unphased trial, it offers a unique opportunity to contribute to understanding dietary impacts on health.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that eating a lot of red meat can have mixed effects on health. Some studies suggest that a diet high in red meat might increase the risk of type 2 diabetes and heart disease. For example, people who consume more red meat have a 62% higher risk of developing type 2 diabetes compared to those who eat less. However, other research indicates that red meat does not affect blood markers related to diabetes.

The healthy U.S.-style diet follows the USDA's MyPlate guidelines, which are generally considered safe and easy to follow. This diet includes a balanced mix of fruits, vegetables, whole grains, lean proteins, and low-fat dairy products. No direct evidence suggests major safety concerns with this approach.

In summary, while opinions vary about the long-term health risks of a diet high in red meat, the balanced U.S.-style diet is widely accepted as safe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these dietary pattern trials for prediabetes because they offer fresh approaches to managing blood sugar levels. The Healthy Beef-Centric Diet is unique as it emphasizes beef as the main protein source, promoting a low-carbohydrate, minimally processed way of eating. This contrasts with the typical advice of reducing red meat intake, providing a potentially appealing option for those who enjoy beef. Meanwhile, the Healthy U.S.-Style Dietary Pattern follows the USDA's MyPlate guidelines, offering a balanced and conventional approach with fruits, vegetables, whole grains, lean proteins, and low-fat dairy. By comparing these two distinct diets, researchers hope to uncover how different dietary patterns can influence prediabetes management and possibly offer new, tailored dietary recommendations.

What evidence suggests that this trial's dietary patterns could be effective for prediabetes?

Research has shown that consuming large amounts of red meat might increase the risk of diabetes. Studies have found links between both processed and unprocessed red meats and a higher risk of diabetes. However, this trial will compare two dietary patterns: the Healthy U.S.-Style Dietary Pattern and the Healthy Beef-Centric Diet. Participants may follow the Healthy Beef-Centric Diet, a high-protein diet that includes beef and emphasizes a balanced intake with minimally processed beef. This diet is low in carbohydrates, which may help control blood sugar levels. ^{1 2 6 7 8}

Who Is on the Research Team?

Shalene McNeill

Principal Investigator

National Cattlemen's Beef Association (NCBA), a contractor to the Beef Checkoff

Are You a Good Fit for This Trial?

This trial is for adults who are pre-diabetic or have metabolic syndrome, which can include conditions like obesity and impaired glucose tolerance. Participants should be experiencing inflammation but not currently have pneumonia.

Inclusion Criteria

Report low levels of physical activity

Consume meat-based protein and regularly consume beef

Not currently using any nicotine-containing products and willing to abstain for 14 days before Visit 2

Exclusion Criteria

Have followed specific diets in the 6 months prior to screening

Have a history of alcohol or substance abuse in the last 12 months

Individuals who are lactating, planning to become pregnant during the study, or pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow either a healthy beef-centric diet or a healthy U.S.-style dietary pattern for 5 weeks

5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Healthy Beef-Centric Diet
• Healthy U.S.-Style Dietary Pattern

Trial Overview The study compares two diets: a healthy beef-centric diet versus a healthy U.S.-style dietary pattern. It aims to see which one is better for reducing inflammation and improving other metabolic health outcomes in participants.

How Is the Trial Designed?

Group I: Healthy Beef-Centric Diet Experimental Treatment 1 Intervention

This is a whole-food dietary pattern that emphasizes beef as the primary source of protein. This diet is designed to reflect a low-carbohydrate, minimally processed eating pattern.

Group II: Healthy U.S.-Style Dietary Pattern Active Control 1 Intervention

This diet is based on USDA's MyPlate dietary guidelines and includes a balanced intake of fruits, vegetables, whole grains, lean proteins, and low-fat dairy. This diet reflects a conventional, guideline-based approach to healthy eating.

Who Is Running the Clinical Trial?

National Cattlemen's Beef Association, a contractor to the Beef Checkoff

Lead Sponsor

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Collaborator

Trials

40

Recruited

2,400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07269847

NCT07269847 | Comparing a Healthy Beef-Centric Diet to ... This study follows a randomized, open-label, parallel design to compare the effects of a healthy beef-centric diet to a healthy U.S.-style ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11390537/

Association between processed red meat intake and ... To explore the association between Processed red meat (PRM) consumption and cardiovascular risk factors in Chinese adults with type 2 diabetes mellitus (T2DM).

3. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322011310

Red Meat, Dietary Heme Iron, and Risk of Type 2 Diabetes This review discusses the findings of cohort studies and meta-analyses of heme iron and red meat intakes and the risk of type 2 diabetes.

4. ajmc.com ajmc.com/view/meat-consumption-and-increased-diabetes-risk-building-on-the-current-evidence-base

Meat Consumption and Increased Diabetes Risk New findings once again revealed that higher consumption of unprocessed red meat and processed meat was associated with an increased risk of diabetes.

5. thinkbeef.ca thinkbeef.ca/beef-and-diabetes-untangling-the-science-of-diabetes-and-red-meat/

untangling the science of diabetes and red meat Researchers found that the higher protein diet, which included beef at least 4 times a week, was as effective as the moderate protein diet with no red meat. A 6 ...

6. hsph.harvard.edu hsph.harvard.edu/news/red-meat-consumption-associated-with-increased-type-2-diabetes-risk/

Red meat consumption associated with increased type 2 ... Participants who ate the most red meat had a 62% higher risk of developing type 2 diabetes compared to those who ate the least. Every additional ...

7. nytimes.com nytimes.com/2024/08/20/well/eat/red-meat-diabetes-study.html

Eating Meat Is Linked With Diabetes Risk, New Studies ... Two recent studies have added to the growing body of evidence that a meat-heavy diet may increase the risk of Type 2 diabetes.

8. thinkbeef.ca thinkbeef.ca/wp-content/uploads/2024/11/Recent-Evidence-on-Red-Meat-Protein-and-Diabetes.pdf

Recent Evidence on Red Meat, Protein, and Diabetes 2023 - A meta-analysis of 21 randomized controlled trials (RCTs) concluded red meat had no adverse effect on a range of blood makers for type 2 diabetes, ...