Plant-Based Diet for Type 2 Diabetes

(DROP Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Neal Barnard, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Physicians Committee for Responsible Medicine

Disqualifiers: Recreational drugs, Pregnancy, Unstable illness, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing an online course that teaches people about eating a plant-based diet. It aims to help community members improve their blood sugar levels, lose weight, and lower cholesterol. The study will see if these health benefits make the program useful for doctors and patients.

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 data supports the effectiveness of the treatment Diabetes Reversal Online Program and Study (DROP Study) for type 2 diabetes?

Research shows that a plant-based diet can be effective for managing type 2 diabetes by improving blood sugar control and potentially reversing the condition. Studies also highlight that lifestyle changes, like diet and exercise, can lead to long-term diabetes remission and improved health outcomes. ^{1 2 3 4 5}

Is a plant-based diet for type 2 diabetes safe for humans?

The research suggests that lifestyle modifications, including diet changes, can lead to diabetes reversal without complications, indicating general safety for humans. ^{1 4 5 6 7}

How is the DROP Study treatment for type 2 diabetes different from other treatments?

The DROP Study treatment is unique because it focuses on a plant-based diet, which emphasizes whole grains, vegetables, fruits, and legumes while excluding animal products. This approach not only helps manage blood sugar levels but also improves body weight, insulin sensitivity, and reduces the need for diabetes medications, offering a natural and holistic way to potentially reverse type 2 diabetes. ^{3 4 5 8 9}

Research Team

Neal Barnard, MD

Principal Investigator

Physicians Committee for Responsible Medicine

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Diabetes Reversal Online Program and Study (DROP Study) (Nutrition Education Program)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Type 2 diabetes reversal with digital twin technology-enabled precision nutrition and staging of reversal: a retrospective cohort study. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Induction of long-term glycemic control in a type 2 diabetic patient for 11 years by intensive lifestyle intervention. [2021]

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

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

4. New Zealand pubmed.ncbi.nlm.nih.gov

Reversal and Remission of T2DM - An Update for Practitioners. [2022]

5. India pubmed.ncbi.nlm.nih.gov

'Daily 2-only meals and exercise' lifestyle modification for remission of type 2 diabetes mellitus: A therapeutic approach. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Antihypertensive medication needs and blood pressure control with weight loss in the Diabetes Remission Clinical Trial (DiRECT). [2022]

7. England 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. [2020]

8. 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]

9. Canada 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. [2017]