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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effects of switching from a Western diet to a plant-based diet in individuals with prediabetes. Researchers aim to assess how this change impacts metabolism (how the body uses energy) and other body functions. Participants will consume plant-based meals and snacks for five weeks. Individuals with prediabetes, a high body weight, and a typical Western diet may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to understanding dietary impacts on prediabetes.

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 prior data suggests that a plant-based diet is safe for diabetes prevention?

Research shows that plant-based diets are generally safe and easy to follow. Studies have found that these diets can reduce the risk of type 2 diabetes and other long-term illnesses. For instance, one study discovered that people who followed a healthy plant-based diet had a 34% lower risk of developing type 2 diabetes. Another study found that sticking to a plant-based diet was linked to a lower risk of getting diabetes and also helped in managing it.

The evidence suggests that switching to a plant-based diet is not only safe but may also provide significant health benefits. These studies reported no serious side effects from plant-based diets, making them a promising choice for improving health and preventing disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for diabetes, which often involve medications to manage blood sugar levels, a plant-based diet focuses on prevention by changing what you eat. Researchers are excited about this approach because it emphasizes whole, plant-based foods that are naturally low in fat and high in fiber. This can improve insulin sensitivity and help maintain healthy blood sugar levels. Additionally, plant-based diets offer a sustainable and side-effect-free alternative, potentially reducing the need for medications.

What evidence suggests that a plant-based diet might be an effective treatment for prediabetes?

Research has shown that eating a plant-based diet can greatly lower the risk of developing type 2 diabetes. Large studies have found that people who primarily consume plant-based foods are much less likely to develop diabetes compared to those who eat a typical Western diet. Specifically, one study found that a healthy plant-based diet reduced the risk of type 2 diabetes by 58%. These diets include plenty of whole grains, fruits, vegetables, beans, lentils, and nuts, which help control blood sugar and lower the risk of diabetes. Overall, switching to a plant-based diet could be a strong way to prevent diabetes. Participants in this trial will follow a plant-based diet for 5 weeks to evaluate its effectiveness in diabetes prevention. ^{1 5 6 7 8}

Who Is on the Research Team?

Jean L Fry, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

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A plant-based diet for the prevention and treatment of type 2 ... Large cohort studies demonstrate that the prevalence and incidence of type 2 diabetes are significantly lower among those following plant-based eating patterns ...

2. diabetesjournals.org diabetesjournals.org/care/article/46/1/6/148190/Diet-and-Diabetes-Prevention-Is-a-Plant-Based-Diet

Diet and Diabetes Prevention: Is a Plant-Based Diet the ... However, there is moderate certainty of evidence that in people diagnosed with diabetes, a vegan diet seems to be effective in reducing body ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2161831324001285

Vegetarian and Vegan Dietary Patterns to Treat Adult Type ... Diets rich in whole grains, vegetables, fruits, dairy, legumes, and nuts and seeds have been shown to lower the risk of T2DM, whereas those high in sugary ...

4. jandonline.org jandonline.org/article/S2212-2672(24)00476-3/fulltext

Plant-based Diet as an Effective Treatment And/or ... The prospective cohort study by Satija, et al showed a 58% reduced risk of type 2 diabetes for participants following a healthful plant-based diet, and a 40% ...

5. nature.com nature.com/articles/s41538-024-00362-y

Utilization of plant-based foods for effective prevention ... Our results indicated that adopting a plant-based diet could provide non-linear protective effects against chronic diseases, with the magnitude ...

6. nutritionj.biomedcentral.com nutritionj.biomedcentral.com/articles/10.1186/s12937-023-00877-2

Associations between plant-based dietary patterns and risks ... Increased adherence to a plant-based dietary pattern was associated with lower risks of T2D (0.83 [95% CI: 0.71–0.96; I2 = 71.5%]) and a ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322004896

Plant-Based Eating Pattern for Type 2 Diabetes Prevention ... A plant-based eating pattern is associated with a reduced risk of developing type 2 diabetes and is highly effective in its treatment.

8. jacc.org jacc.org/doi/10.1016/j.jacadv.2025.102229

Plant-Based Diet Quality, Healthy Lifestyle, and Dementia ... This large prospective study reveals significantly reduced dementia risk in older adults with CMDs consuming a predominantly WFPB diet. These ...