24 Participants NeededMy employer runs this trial

Beetroot Juice for Prediabetes

(NO3-PreDM Trial)

MG
Overseen ByMoney Ghimire, M.S
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Virginia
Must be taking: Metformin

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether beetroot juice, rich in inorganic nitrate, can improve blood vessel health, insulin sensitivity, and exercise capacity in people with prediabetes. Researchers are comparing two groups: those taking metformin (a common diabetes medication) and those who are not. The goal is to determine if beetroot juice could serve as a non-drug option for managing prediabetes. Candidates may be suitable if they have prediabetes, do not exercise much, and can ride a stationary bike.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could lead to new, non-drug management options for prediabetes.

Will I have to stop taking my current medications?

The trial requires that you have a stable medication regimen for the last 6 months and excludes those taking certain medications like calcium channel blockers, statins, and others. If you're on any of these excluded medications, you would need to stop taking them to participate.

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

Research has shown that beetroot juice, rich in inorganic nitrate, is generally safe for consumption. Studies have found that participants who drank beetroot juice experienced benefits such as lower blood pressure and improved metabolic health. These studies reported no serious side effects, indicating good tolerance of the juice.

In one study, participants drinking beetroot juice showed no negative changes in insulin handling. Another study found that consuming high-nitrate beetroot juice for two weeks helped lower blood pressure in individuals with type 2 diabetes, again without major safety concerns.

These findings suggest that beetroot juice is safe for use in clinical trials, with no major safety issues reported so far. However, consulting a healthcare provider before starting any new supplement is always important.12345

Why are researchers excited about this trial?

Most treatments for prediabetes rely on medications like metformin, which work by improving insulin sensitivity and reducing glucose production in the liver. However, beetroot juice is unique because it harnesses the power of inorganic nitrates to potentially improve blood sugar control. Researchers are excited about this treatment because it could offer a natural, dietary option that works by enhancing nitric oxide production, improving blood flow, and possibly even insulin sensitivity. Unlike traditional medications, which can take weeks to show effects, beetroot juice might deliver benefits in just a few days, making it an appealing alternative for those looking for quicker results.

What evidence suggests that beetroot juice could be an effective treatment for prediabetes?

Research has shown that beetroot juice, rich in natural compounds called nitrates, can help control blood sugar and improve heart and blood vessel health. For instance, one study found that drinking beetroot juice lowers the rise in insulin and sugar levels after eating. Another study suggests that the nitrates in beetroot juice might help the body use sugar more effectively. Beetroot juice may also help lower blood pressure, a common concern for people with prediabetes. This trial will evaluate the effects of nitrate-rich beetroot juice compared to nitrate-depleted beetroot juice in participants who are either naive to metformin or currently taking metformin. Overall, these findings suggest that beetroot juice could be a useful, natural option for managing prediabetes by supporting healthy blood vessels and insulin function.23678

Who Is on the Research Team?

AW

Arthur Weltman, PhD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 with prediabetes who are mostly inactive, can exercise on a stationary bike, have had stable medications for at least 6 months, and either take metformin or have never taken it. Women must have regular periods.

Inclusion Criteria

I am either new to metformin or have been on a stable dose for at least a week.
I can understand the study and give written consent.
I am 18-60 years old and have been diagnosed with prediabetes by blood tests.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nitrate-rich or nitrate-depleted beetroot juice supplementation for 4 days, followed by a 7-day washout period before crossover

4 days per treatment cycle
Multiple lab visits for testing and supplementation

Follow-up

Participants are monitored for changes in vascular function, insulin sensitivity, and exercise capacity after treatment

4 days
Lab visits for outcome measures

What Are the Treatments Tested in This Trial?

Interventions

  • Inorganic Nitrate (Beetroot juice)

Trial Overview

The study tests if drinking beetroot juice (which contains inorganic nitrate) improves blood vessel health, insulin sensitivity, and exercise ability in people with prediabetes. Some participants will get real beetroot juice; others will get a placebo without nitrate.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Active Comparator (Taking metformin)Experimental Treatment1 Intervention
Group II: Active Comparator (Naive to metformin)Experimental Treatment1 Intervention
Group III: Placebo Comparator (Naive to metformin)Placebo Group1 Intervention
Group IV: Placebo Comparator (Taking metformin)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials
802
Recruited
1,342,000+

Citations

Effects of concentrated beetroot juice consumption on ... - PMC

The results indicated a significantly lowered postprandial insulin response in 0–60 min and a significantly lowered glucose response in 0–30 min ...

Dietary nitrate supplementation improves reaction time in ...

Two weeks supplementation of the diet with 7.5 mmol of nitrate per day caused a significant improvement in simple reaction time in individuals with T2DM.

The Effects of Acute Beetroot Juice Intake on Glycemic and ...

Several studies have shown that the consumption of dietary inorganic nitrate may improve vascular health and glucose regulation in animal models ...

A Preliminary Analysis On The Effects Of Acute Beetroot ...

Their data suggests that diNO3 may assist with decreasing blood pressure and could be beneficial for glucose disposal. Gheibi et al has also ...

Interaction Between Inorganic Nitrate Supplementation and ...

This study is examining whether short-term supplementation with inorganic nitrate, in the form of beetroot juice, can enhance blood vessel ...

Effects of raw red beetroot consumption on metabolic markers ...

Raw red beetroot consumption for 8 weeks in T2DM patients has beneficial impacts on cognitive function, glucose metabolism and other metabolic markers.

Inorganic Nitrate and Beetroot Juice Supplementation ...

Inorganic nitrate and beetroot juice supplementation was associated with a significant reduction in systolic BP. These findings need to be tested in long-term ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35639721/

Dietary Inorganic Nitrate/Nitrite Supplementation Reduces ...

Dietary Inorganic Nitrate/Nitrite Supplementation Reduces Central and Peripheral Blood Pressure in Patients With Type 2 Diabetes Mellitus.