Abscisic Acid for Insulin Resistance and Prediabetes

(ABA Trial)

Overseen By Recruitment Department

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Translational Research Institute for Metabolism and Diabetes, Florida

Must not be taking: Antioxidants, Supplements

Disqualifiers: Diabetes, Heart disease, Stroke, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether abscisic acid (ABA), taken as a pill, can improve sugar metabolism in people with prediabetes. Researchers aim to determine if ABA can enhance the body's sugar usage, potentially preventing diabetes. Participants will receive either ABA or a placebo (a pill with no active ingredient) for 14 days. The trial seeks individuals with prediabetes who struggle to manage their blood sugar levels. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial requires that you stop taking any medications or antioxidant vitamins or supplements that could affect glucose metabolism.

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

Research has shown that oral abscisic acid (ABA) is generally safe for humans. In a study on its effects on prediabetes, ABA significantly reduced inflammation by lowering Hs-CRP levels, markers of inflammation, by about 23%. This suggests it might improve overall health without causing major side effects.

Other studies have found that ABA can help control blood sugar in both lab settings and healthy individuals. For example, ABA helps muscles and fat cells absorb glucose, which can benefit blood sugar management. Additionally, animal studies have shown that ABA increases insulin sensitivity and reduces obesity-related inflammation.

While these findings are promising, this treatment is still under testing. The current trial phase examines both safety and effectiveness, indicating that earlier human studies have already demonstrated some level of safety. As always, consider discussing any concerns with a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prediabetes?

Unlike standard treatments for insulin resistance and prediabetes, which often include lifestyle changes and medications like metformin that aim to improve insulin sensitivity, abscisic acid (ABA) offers a unique approach. Researchers are excited about ABA because it is a naturally occurring plant hormone that may help regulate blood sugar levels by influencing glucose metabolism differently. This new mechanism of action could potentially lead to improved management of insulin resistance and offer an alternative for those who cannot tolerate traditional medications. Additionally, ABA is taken orally and may show results in just 14 days, which is a relatively short time frame compared to other treatments.

What evidence suggests that oral abscisic acid (ABA) might be an effective treatment for prediabetes?

This trial will compare the effects of oral abscisic acid (ABA) with a placebo in participants with insulin resistance and prediabetes. Studies have shown that ABA can improve blood sugar control and reduce inflammation in people with prediabetes. In mice, a single dose of ABA, combined with a small amount of insulin, significantly lowered blood sugar levels. Research has also found that healthy individuals have higher levels of ABA compared to those with diabetes, suggesting ABA's role in maintaining balance in the body. Additional studies indicate that ABA can lower fasting insulin levels and improve sugar processing, suggesting its potential as a promising option for managing prediabetes. ^{1 2 3 4 6}

Who Is on the Research Team?

Bret Goodpaster, PhD

Principal Investigator

Principal Investigator

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with prediabetes, marked by fasting glucose levels between 5.6 and 7.0 mmol/L or HbA1C between 5.6% and 6.5%. Participants must be in good health, able to take oral medication, agree to lifestyle guidelines, and use effective contraception if necessary. Exclusions include recent other trials, certain physical exam findings, smoking within a year, diabetes treatment, BMI outside of the range of 19-40 kg/m2.

Inclusion Criteria

In good general health as evidenced by medical history or diagnosed with <specify condition/disease> or exhibiting <specify clinical signs or symptoms or physical/oral examination findings>

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

Treatment with another investigational drug or other intervention within 1 year.

Disqualifying findings on physical examination include cardiac murmurs, diminished pulses or the presence of bruits in the lower extremities, lower extremity thrombophlebitis, evidence of peripheral neuropathy, paresis or edema.

Pregnancy or lactation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either oral abscisic acid (ABA) or placebo for 14 days

2 weeks

Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Regular visits for monitoring adverse events

What Are the Treatments Tested in This Trial?

Interventions

• Oral abscisic acid (ABA)
• Placebo

Trial Overview The study tests how oral abscisic acid (ABA) affects blood sugar control and insulin sensitivity in people with prediabetes compared to a placebo group. It involves procedures like the hyperinsulinemic-euglycemic clamp technique to measure insulin sensitivity and muscle biopsies to examine tissue responses.

How Is the Trial Designed?

Group I: ABA group Active Control 3 Interventions

95 ug 2x/day for 14 days

Group II: Placebo group Placebo Group 3 Interventions

Corn Starch 300 mg for 14 days

Who Is Running the Clinical Trial?

Translational Research Institute for Metabolism and Diabetes, Florida

Lead Sponsor

Trials

41

Recruited

3,600+

AdventHealth Translational Research Institute

Lead Sponsor

Trials

51

Recruited

5,900+

BioTherapeutics Inc.

Industry Sponsor

Trials

1

Recruited

50+

Citations

1. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2017.00024/full

Abscisic Acid: A Novel Nutraceutical for Glycemic Control Furthermore, dietary ABA supplementation significantly reduced fasting insulin levels (65). While the benefits of ABA on glucose tolerance are clear, additional ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7599846/

Abscisic Acid Treatment in Patients with Prediabetes - PMC Conclusions: abscisic acid can be effective in ameliorating glyco-metabolic compensation and in reducing inflammatory status in patients with IFG or IGT.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9227369/

Abscisic Acid Improves Insulin Action on Glycemia in Insulin ... Diabetic mice treated with a single oral dose of ABA and low-dose subcutaneous insulin showed a significantly reduced glycemia profile compared ...

4. mdpi.com mdpi.com/2673-4540/6/9/93

Abscisic Acid as a Marker of Metabolic Imbalance Results: Our findings show that ABA levels were significantly higher in healthy subjects (10.9 ± 3.8 ng/mL) compared to diabetic patients (6.8 ± 4.2 ng/mL, p < ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1388198116303067

Abscisic acid enhances glucose disposal and induces ... ABA stimulates glucose uptake by myocytes and pre-adipocytes in vitro and oral ABA improves glycemic control in rats and in healthy subjects. Here we ...

6. nature.com nature.com/articles/s41598-020-67300-2

Abscisic acid enriched fig extract promotes insulin ... We discovered that dietary ABA increases insulin sensitivity and suppresses obesity-related inflammation in obese/diabetic db/db mice. Dietary ...