Plant-Based Diet for Diabetes Prevention

Recruiting at 1 trial location

Overseen By Kayla R Anderson, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Jean L. Fry

Must not be taking: Insulin sensitivity drugs

Disqualifiers: Diabetes, Bariatric surgery, Hormone therapy, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants do not take medications that may affect insulin sensitivity or any that significantly affect weight or metabolism. If you are on such medications, you may need to stop taking them to participate.

What data supports the effectiveness of the treatment Plant-based diet, Vegan diet, Vegetarian diet, Whole-food plant-based diet for diabetes prevention?

Research shows that plant-based diets, which focus on whole grains, vegetables, fruits, and legumes, can lower the risk of developing type 2 diabetes and help manage it by improving blood sugar levels, body weight, and cholesterol. These diets also reduce the risk of heart and blood vessel complications related to diabetes. ^{1 2 3 4 5}

Is a plant-based diet safe for humans?

Research shows that plant-based diets, including vegan and whole-food plant-based diets, are generally safe for humans. They are associated with improved blood sugar control, weight management, and reduced risk of heart disease, with no significant safety concerns reported. ^{1 3 4 5 6}

How is a plant-based diet unique in treating type 2 diabetes?

A plant-based diet is unique in treating type 2 diabetes because it focuses on whole grains, vegetables, fruits, and legumes while excluding animal products, which helps improve blood sugar levels, body weight, and heart health. This approach can be more effective than conventional diets due to its emphasis on low-fat, high-fiber foods and reduced intake of saturated fats, offering potential advantages in managing diabetes. ^{3 5 6 7 8}

What is the purpose of this trial?

The primary purpose of this study is to determine the sex-specific metabolic and molecular response, among adults with prediabetes, when moving from a Western Diet to plant-based diet.

Research Team

Jean L Fry, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for adults with prediabetes, which means they have higher than normal blood sugar levels but not high enough to be diabetes. They should currently follow a Western Diet and are interested in switching to a plant-based diet.

Inclusion Criteria

Body mass index greater than or equal to 27

Physical activity below national guidelines

Following a Western diet

Exclusion Criteria

I have had weight loss surgery in the past.

I take medication that can affect how my body uses insulin.

More than 5% weight change within 6 months of screening

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in

Participants undergo a run-in period before starting the plant-based diet intervention

1 week

Treatment

Participants receive 4 weeks of plant-based meals and snacks

4 weeks

Follow-up

Participants are monitored for changes in insulin sensitivity and other metabolic markers

5 weeks

Treatment Details

Interventions

• Plant-based diet

Trial Overview The study aims to see how men and women's bodies react differently when they switch from a typical Western Diet—rich in processed foods—to a diet based on plants only.

Participant Groups

Group I: Plant-based diet Experimental Treatment 1 Intervention

5 weeks of plant-based meals and snacks.

Who Is Running the Clinical Trial?

Jean L. Fry

Lead Sponsor

Trials

1

Recruited

6+

Findings from Research

In a 20-week trial involving 40 participants with type 2 diabetes, both a low-fat vegan eating plan and a portion-controlled eating plan led to significant improvements in body weight, hemoglobin A1c (HbA1c), and LDL cholesterol levels, indicating effective dietary interventions for diabetes management.

Despite the improvements in metabolic markers, there were no significant differences between the two eating plans, suggesting that both approaches can be beneficial for individuals with type 2 diabetes when integrated into a clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Turning the Waiting Room into a Classroom: Weekly Classes Using a Vegan or a Portion-Controlled Eating Plan Improve Diabetes Control in a Randomized Translational Study. Barnard, ND., Levin, SM., Gloede, L., et al.[2022]

Plant-based diets may help delay the progression of diabetic kidney disease (DKD) by focusing on whole foods and reducing processed foods and advanced glycation end products (AGE).

Current evidence is limited and mostly from smaller studies, highlighting the need for larger trials to better understand the impact of plant-based diets on kidney function and overall health outcomes in DKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and Diabetic Kidney Disease: Plant Versus Animal Protein. Moorthi, RN., Vorland, CJ., Hill Gallant, KM.[2022]

In a study involving 35 adults at risk of type 2 diabetes, including 2 eggs daily in a plant-based diet did not negatively impact key cardiometabolic risk factors such as endothelial function, lipid profile, blood pressure, or insulin sensitivity.

Egg inclusion significantly improved dietary intake of important nutrients like selenium and choline, suggesting that eggs can enhance the nutritional quality of plant-based diets for individuals at risk of type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Egg Consumption in the Context of Plant-Based Diets and Cardiometabolic Risk Factors in Adults at Risk of Type 2 Diabetes. Njike, VY., Treu, JA., Kela, GCM., et al.[2023]

In a pilot program involving 17 participants, the adoption of a Whole Food Plant-based (WFPB) diet resulted in significant weight loss (4.3 kg) and improvements in cholesterol levels, including a decrease in total cholesterol and triglycerides, and an increase in HDL (good cholesterol).

The program, which included educational sessions led by a gastroenterologist, demonstrated the potential effectiveness of WFPB diets in a clinical setting, particularly for patients with conditions like hyperlipidemia and hypertension, suggesting a need for larger-scale studies to further validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a Whole Food Plant Based Diet in a Food as Prevention Program in a Resource Constrained Environment. Ganguli, SC., Russell, LA., Tsoi, KS.[2023]

A plant-based eating pattern, which includes whole grains, vegetables, fruits, and legumes while excluding animal products, is linked to a lower risk of developing type 2 diabetes and is effective in managing the condition.

This diet improves key health markers such as blood glucose levels, body weight, and blood pressure, and it also enhances insulin sensitivity and β-cell function, which are crucial for diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspective: Plant-Based Eating Pattern for Type 2 Diabetes Prevention and Treatment: Efficacy, Mechanisms, and Practical Considerations. Jardine, MA., Kahleova, H., Levin, SM., et al.[2023]

Plant-based nutrition education is an effective intervention for managing type 2 diabetes, helping to improve glycemic control and reduce body weight.

A low-fat, plant-based diet is not only well-accepted by patients but also beneficial for reducing cardiac risk, making it a comprehensive approach for diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A plant-based diet for type 2 diabetes: scientific support and practical strategies. Trapp, C., Barnard, N., Katcher, H.[2020]

Vegetarian and especially vegan diets have shown significant benefits in preventing and managing diabetes, improving weight control, blood sugar levels, and cardiovascular health.

Carefully planned vegan diets can be more nutritious than conventional diets and are comparable in acceptability to other therapeutic regimens, making them a viable option for individuals with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usefulness of vegetarian and vegan diets for treating type 2 diabetes. Trapp, CB., Barnard, ND.[2021]

Individuals following vegetarian diets are about 50% less likely to develop diabetes compared to non-vegetarians, highlighting the preventive benefits of plant-based eating.

In clinical trials, low-fat vegan diets not only improve glycemic control more effectively than conventional diabetes diets but also contribute to better plasma lipid levels and may even reverse atherosclerosis progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vegetarian and vegan diets in type 2 diabetes management. Barnard, ND., Katcher, HI., Jenkins, DJ., et al.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Turning the Waiting Room into a Classroom: Weekly Classes Using a Vegan or a Portion-Controlled Eating Plan Improve Diabetes Control in a Randomized Translational Study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Diet and Diabetic Kidney Disease: Plant Versus Animal Protein. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Egg Consumption in the Context of Plant-Based Diets and Cardiometabolic Risk Factors in Adults at Risk of Type 2 Diabetes. [2023]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Implementation of a Whole Food Plant Based Diet in a Food as Prevention Program in a Resource Constrained Environment. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Perspective: Plant-Based Eating Pattern for Type 2 Diabetes Prevention and Treatment: Efficacy, Mechanisms, and Practical Considerations. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

A plant-based diet for type 2 diabetes: scientific support and practical strategies. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Usefulness of vegetarian and vegan diets for treating type 2 diabetes. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Vegetarian and vegan diets in type 2 diabetes management. [2015]