Abscisic Acid Effects on Glucose Homeostasis and Insulin Sensitivity (ABA)

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

Study Overview

• Status: Completed
• Conditions: Pre Diabetes
• Intervention / Treatment: Other: Hyperinsulemic euglycemic clamp; Procedure: Muscle Biopsy; Dietary supplement: Oral abscisic acid (ABA); Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32803
      • AdventHealth Translational Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18-65
4. 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>
5. Fasting glucose >5.6 and<7.0 mmol/L and/or HbA1C >5.6 and <6.5 %
6. Ability to take oral medication and be willing to adhere to the <study intervention> regimen
7. Females currently on hormone replacement therapy (HRT) can participate in the study if they have been on HRT for at least 6 months and will continue to be on HRT during the study.
8. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
9. Agreement to adhere to Lifestyle Considerations throughout study duration.

Exclusion Criteria

1. Treated or untreated diabetes
2. 19>BMI<40.0 kg/m2
3. Blood pressure (BP) ≤ 150mmHg systolic and ≤ 95 mmHg diastolic
4. Current use of medications or antioxidant vitamins or supplements that would impact dependent variables, including glucose metabolism.
5. Past or current ischemic heart disease, stroke, respiratory disease, endocrine or metabolic disease, neurological disease, hematological-oncological disease and free of recent infection (prior 2 weeks)
6. Pregnancy or lactation
7. Treatment with another investigational drug or other intervention within 1 year.
8. Current smoker or tobacco use within the past year.
9. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ABA group; 95 ug 2x/day for 14 days	Other: Hyperinsulemic euglycemic clamp; Following a 12-hour overnight fast at the CRU (including abstinence from caffeine containing foods and beverages), insulin sensitivity will be measured using the criterion method of the euglycemic clamp. Participants will have not performed vigorous physical activity for at least the previous 24 h, and be free of acute illness for the prior 2 weeks. An intravenous catheter will be placed in an antecubital vein for subsequent insulin (40 mU/m2-min) and glucose infusions and for stable isotope (6, 6-2H2) infusions to measure insulin sensitivity.; Procedure: Muscle Biopsy; One biopsy taken prior to clamp and a second biopsy taken 30-45 min after the start of the clamp. A biopsy of the Vastus Lateralis muscle will be performed on the leg/thigh using the Bergstrom technique.; Dietary supplement: Oral abscisic acid (ABA); Those in this group will receive ABA (95 µg ABA and 300 mg of corn starch)
Placebo Comparator: Placebo group; Corn Starch 300 mg for 14 days	Other: Hyperinsulemic euglycemic clamp; Following a 12-hour overnight fast at the CRU (including abstinence from caffeine containing foods and beverages), insulin sensitivity will be measured using the criterion method of the euglycemic clamp. Participants will have not performed vigorous physical activity for at least the previous 24 h, and be free of acute illness for the prior 2 weeks. An intravenous catheter will be placed in an antecubital vein for subsequent insulin (40 mU/m2-min) and glucose infusions and for stable isotope (6, 6-2H2) infusions to measure insulin sensitivity.; Procedure: Muscle Biopsy; One biopsy taken prior to clamp and a second biopsy taken 30-45 min after the start of the clamp. A biopsy of the Vastus Lateralis muscle will be performed on the leg/thigh using the Bergstrom technique.; Other: Placebo; Those in this group will receive placebo (300 mg cornstarch)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monitoring Adverse Events	Adverse events will be monitored at each visit throughout the duration of the study.	10 weeks
Insulin Sensitivity	Rate of glucose disposal, measured by hyperinsulinic euglycemic clamp, normalized to pre-treatment baseline (mg/min)	After 2 weeks of treatment

Collaborators and Investigators

• Sponsor: AdventHealth Translational Research Institute
• Collaborators: BioTherapeutics Inc.
• Investigators: Principal Investigator: Bret Goodpaster, PhD, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2021
• Primary Completion (Actual): August 26, 2024
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: metabolism
• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Hyperglycemia; Nutritional and Metabolic Diseases; Glucose Intolerance; Organic Chemicals; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Carboxylic Acids; Acids, Carbocyclic; Sesquiterpenes; Cyclohexanecarboxylic Acids; Monocyclic Sesquiterpenes; Abscisic Acid
• Other Study ID Numbers: 1545505

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No