Plant-Based Diet for Type 2 Diabetes

(DROP Trial)

Recruiting at 1 trial location

Overseen By Roxanne Becker, MBChB

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Physicians Committee for Responsible Medicine

Disqualifiers: Recreational drugs, Pregnancy, Unstable illness, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a 12-week, online plant-based nutrition program can help manage type 2 diabetes. Researchers seek to discover whether a low-fat vegan diet can reduce blood sugar levels, body weight, and cholesterol. The study is open to U.S. adults already diagnosed with type 2 diabetes. Participants will follow the diet and join an online community to learn more about plant-based eating. As an unphased trial, this study provides a unique opportunity to explore the potential benefits of plant-based nutrition in managing diabetes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants must be able to maintain their current medication regimen.

What prior data suggests that this program is safe for participants?

Research has shown that a low-fat vegan diet can be well-tolerated by people with type 2 diabetes. In one study, participants on this diet lost significant weight without restricting their food intake. Another study found that individuals following plant-based diets have a lower risk of developing type 2 diabetes.

Additionally, evidence suggests that vegans are 49% less likely to have diabetes compared to non-vegans. For managing diabetes, 43% of individuals on a low-fat vegan diet reduced their diabetes medications, which is encouraging.

Overall, these studies indicate that a vegan diet might be a safe and effective option for people with type 2 diabetes. No major negative effects have been reported, making it a potentially safe choice for those considering this dietary change. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for type 2 diabetes, which often include medications like metformin or insulin, this approach focuses on a low-fat vegan diet. Researchers are excited about this treatment because it potentially addresses the root causes of diabetes by improving insulin sensitivity and reducing inflammation through plant-based nutrition. This diet could offer a drug-free way to manage or even reverse diabetes symptoms, potentially minimizing side effects and reducing the need for lifelong medication.

What evidence suggests that this plant-based diet is effective for type 2 diabetes?

Studies have shown that a vegan diet can effectively manage type 2 diabetes. Research indicates that consuming only plant-based foods improves blood sugar levels, aids in weight loss, and lowers cholesterol. It also reduces the need for diabetes medications by enhancing insulin use in the body. Additionally, this diet lowers the risk of heart problems, which is crucial for people with diabetes. Overall, switching to a vegan diet might powerfully manage and possibly reverse type 2 diabetes. Participants in this trial will follow a low-fat vegan diet to evaluate its effectiveness in managing type 2 diabetes. ^{1 6 7 8 9}

Who Is on the Research Team?

Neal Barnard, MD

Principal Investigator

Physicians Committee for Responsible Medicine

Are You a Good Fit for This Trial?

The DROP Study is for U.S. adults with type 2 diabetes who can maintain their current medication regimen. Participants must be fluent in English and not use recreational drugs, be pregnant, or plan to become pregnant during the study. They should also be able to participate fully in the program.

Inclusion Criteria

I have been diagnosed with type 2 diabetes.

I am of legal age to participate in this trial based on my state's law.

Exclusion Criteria

Pregnancy or intention to become pregnant during the study period, as verified by self-report

I am not fluent in English.

You have used recreational drugs in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a 12-week, online, plant-based, nutrition education program

12 weeks

Online program with weekly tracking

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Diabetes Reversal Online Program and Study (DROP Study)

Trial Overview This trial tests a 20-week online education program promoting a plant-based diet for people with type 2 diabetes. It aims to see if this approach is practical and effective at lowering blood sugar levels, weight, and cholesterol in a community setting.

How Is the Trial Designed?

Group I: Vegan diet Experimental Treatment 1 Intervention

All participants will follow a low-fat vegan diet. There are no other study arms or control group.

Who Is Running the Clinical Trial?

Physicians Committee for Responsible Medicine

Lead Sponsor

Trials

30

Recruited

2,600+

Published Research Related to This Trial

Plant-based diets (PBDs) are associated with a lower prevalence of type 2 diabetes and have been shown to be as effective, if not more effective, than other diabetes diets in improving various health markers such as body weight, insulin sensitivity, and glycated hemoglobin levels.

Patient acceptability of PBDs is comparable to other diabetes diets, and they can reduce the need for diabetes medications, suggesting that PBDs could be a beneficial dietary approach in managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comprehensive Review of the Literature Supporting Recommendations From the Canadian Diabetes Association for the Use of a Plant-Based Diet for Management of Type 2 Diabetes. Rinaldi, S., Campbell, EE., Fournier, J., et al.[2017]

The top research priority for people with Type 2 diabetes is understanding whether the condition can be cured or reversed, and identifying the best methods for achieving this, as highlighted by a survey conducted by the James Lind Alliance and Diabetes UK.

Current evidence suggests that weight loss can lead to a stable remission of Type 2 diabetes, but if individuals regain weight, the condition is likely to return, emphasizing the importance of maintaining weight loss to prevent recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can type 2 diabetes be reversed and how can this best be achieved? James Lind Alliance research priority number one. Taylor, R., Barnes, AC.[2020]

A planned withdrawal of antihypertensive medications during a low-energy diet led to significant reductions in blood pressure (BP) over 24 months, with 28% of participants remaining off medications after the diet.

While it was generally safe to stop antihypertensives, 27.5% of participants required reintroduction of medications due to raised BP, especially those who were on multiple drugs, highlighting the need for regular BP monitoring during the diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antihypertensive medication needs and blood pressure control with weight loss in the Diabetes Remission Clinical Trial (DiRECT). Leslie, WS., Ali, E., Harris, L., et al.[2022]

In a study of 463 patients, a 90-day precision nutrition therapy led to significant improvements in diabetes reversal stages, with more patients moving from higher stages of medication use to lower stages, indicating better management of type 2 diabetes.

The study defined seven stages of diabetes reversal, showing that after 90 days, the percentage of patients in the most severe stage (Stage 6) decreased from 85% to 11%, highlighting the potential effectiveness of personalized nutrition interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Type 2 diabetes reversal with digital twin technology-enabled precision nutrition and staging of reversal: a retrospective cohort study. Shamanna, P., Joshi, S., Shah, L., et al.[2021]

The review highlights that type 2 diabetes (T2DM), traditionally viewed as irreversible, can potentially be reversed through various therapeutic approaches, including diet, as acknowledged by the World Health Organization in 2016.

Despite evidence supporting diabetes reversal, it is not yet recognized as a standard treatment goal in international guidelines, which primarily focus on general lifestyle interventions rather than specific dietary strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reversal and Remission of T2DM - An Update for Practitioners. Shibib, L., Al-Qaisi, M., Ahmed, A., et al.[2022]

Intensive lifestyle interventions that promote weight loss can lead to the recovery of islet β cell function, which is crucial for insulin production.

This recovery can effectively change the natural progression of type 2 diabetes, suggesting that diabetes can be reversed through significant lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Induction of long-term glycemic control in a type 2 diabetic patient for 11 years by intensive lifestyle intervention. Ou, Q., Cen, C., Fan, C., et al.[2021]

A case series of five patients with type 2 diabetes in Maharashtra, India, showed that lifestyle modifications led to significant improvements, including weight loss and reduced insulin resistance, resulting in lower glycated hemoglobin (HbA1c) levels.

Complete diabetes reversal was achieved in patients with HbA1c levels between 8% and 15% through lifestyle changes alone, highlighting the potential of this approach as a cost-effective and sustainable solution for managing type 2 diabetes in communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Daily 2-only meals and exercise' lifestyle modification for remission of type 2 diabetes mellitus: A therapeutic approach. Dixit, JV., Giri, PA., Badgujar, SY.[2022]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8634508/

Perspective: Plant-Based Eating Pattern for Type 2 Diabetes ... Plant-based diets, particularly vegan diets, improve glycemic control, body weight, and cardiovascular risk factors in individuals with type 2 diabetes. Each of ...

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

Vegetarian and Vegan Dietary Patterns to Treat Adult Type ... Plant-based dietary patterns, including vegetarian and vegan options, may be effective in preventing and managing T2DM by contributing to the maintenance of a ...

3. advances.nutrition.org advances.nutrition.org/article/S2161-8313(24)00130-3/fulltext

The Current Evidence for Vegetarian and Vegan Diets in the ... The outcomes ranged from glycemic control, insulin markers, and BMI (kg/m2), to blood lipids, reduction of glucose-lowering medications, and ...

4. drc.bmj.com drc.bmj.com/content/6/1/e000534

Effectiveness of plant-based diets in promoting well-being ... Vegetarian diet improves insulin resistance and oxidative stress markers more than conventional diet in subjects with Type 2 diabetes. Diabet ...

5. lifestylemedicine.org lifestylemedicine.org/benefits-plant-based-nutrition-type2-diabetes/

Treatment and prevention of type 2 diabetes Plant-predominant diets are associated with decreased risk of developing type 2 diabetes, offering a safe and effective way to control blood sugar levels.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5466941/

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 ...

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

Associations between plant-based dietary patterns and risks ... An inverse association was observed between higher adherence to a plant-based dietary pattern and risks of T2D (RR, 0.82 [95% CI: 0.77–0.86]), ...

8. nutrition.org nutrition.org/plant-based-diets-and-diabetes/

Plant-Based Diets and Diabetes In this long-term cohort study, the prevalence of diabetes was 49% less among vegans and 46% less among lacto-ovo vegetarians compared with non- ...

9. diabetesjournals.org diabetesjournals.org/care/article/29/8/1777/28693/A-Low-Fat-Vegan-Diet-Improves-Glycemic-Control-and

A Low-Fat Vegan Diet Improves Glycemic Control and ... RESULTS—Forty-three percent (21 of 49) of the vegan group and 26% (13 of 50) of the ADA group participants reduced diabetes medications.