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

48 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the effects of oral abscisic acid (ABA) on glucose metabolism in subjects with defined prediabetes.

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.

What evidence supports the effectiveness of the treatment oral abscisic acid (ABA) for insulin resistance and prediabetes?

Research shows that low-dose abscisic acid (ABA) can improve blood sugar control and reduce cholesterol and body weight in both humans and mice. ABA helps the body manage glucose (sugar) levels by enhancing glucose uptake in muscles without relying on insulin, which may benefit people with prediabetes or insulin resistance. ^{1 2 3 4 5}

Is abscisic acid (ABA) safe for human use?

Abscisic acid (ABA) is a natural compound found in fruits and vegetables, and studies suggest it is generally safe for humans when taken in low doses. Research in humans and animals has shown that ABA can improve blood sugar levels and has anti-inflammatory effects, with no significant safety concerns reported. ^{1 2 3 5 6}

How does the drug abscisic acid (ABA) work for insulin resistance and prediabetes?

Abscisic acid (ABA) is unique because it helps control blood sugar levels without relying on insulin by activating a different pathway in the body. It is taken orally in small doses and works by improving glucose uptake in muscles and increasing energy use, which can help manage prediabetes and insulin resistance. ^{1 2 3 5 7}

Research Team

Bret Goodpaster, PhD

Principal Investigator

Principal Investigator

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Chronic Intake of Micrograms of Abscisic Acid Improves Glycemia and Lipidemia in a Human Study and in High-Glucose Fed Mice. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Abscisic Acid: A Novel Nutraceutical for Glycemic Control. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Abscisic Acid: A Conserved Hormone in Plants and Humans and a Promising Aid to Combat Prediabetes and the Metabolic Syndrome. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Abscisic Acid Improves Insulin Action on Glycemia in Insulin-Deficient Mouse Models of Type 1 Diabetes. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Insulin-independent stimulation of skeletal muscle glucose uptake by low-dose abscisic acid via AMPK activation. [2021]

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

Dietary abscisic acid ameliorates influenza-virus-associated disease and pulmonary immunopathology through a PPARγ-dependent mechanism. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Abscisic acid enriched fig extract promotes insulin sensitivity by decreasing systemic inflammation and activating LANCL2 in skeletal muscle. [2021]