Abscisic Acid Effects on Glucose Homeostasis and Insulin Sensitivity

NCT04722354 | Completed Phase 2 Results DMC

• 1 other identifier: 1545505
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pre Diabetes

Keywords

metabolism

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

ABA group

ACTIVE COMPARATOR

95 ug 2x/day for 14 days

Other: Hyperinsulemic euglycemic clamp; Procedure: Muscle Biopsy; Dietary Supplement: Oral abscisic acid (ABA)

Placebo group

PLACEBO COMPARATOR

Corn Starch 300 mg for 14 days

Other: Hyperinsulemic euglycemic clamp; Procedure: Muscle Biopsy; Other: Placebo

Interventions

Hyperinsulemic euglycemic clamp OTHER

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.

ABA group; Placebo group

Muscle Biopsy PROCEDURE

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.

ABA group; Placebo group

Oral abscisic acid (ABA) DIETARY_SUPPLEMENT

Those in this group will receive ABA (95 µg ABA and 300 mg of corn starch)

ABA group

Placebo OTHER

Those in this group will receive placebo (300 mg cornstarch)

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 18-65
• 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\>
• Fasting glucose \>5.6 and\<7.0 mmol/L and/or HbA1C \>5.6 and \<6.5 %
• Ability to take oral medication and be willing to adhere to the \<study intervention\> regimen
• 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.
• For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
• Agreement to adhere to Lifestyle Considerations throughout study duration.

You may not qualify if:

• Treated or untreated diabetes
• \>BMI\<40.0 kg/m2
• Blood pressure (BP) ≤ 150mmHg systolic and ≤ 95 mmHg diastolic
• Current use of medications or antioxidant vitamins or supplements that would impact dependent variables, including glucose metabolism.
• 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)
• Pregnancy or lactation
• Treatment with another investigational drug or other intervention within 1 year.
• Current smoker or tobacco use within the past 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.

Sponsors & Collaborators

• AdventHealth Translational Research Institute: lead
• BioTherapeutics Inc.: collaborator

Study Sites (1)

AdventHealth Translational Research Institute

Orlando, Florida, 32803, United States

Location

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Abscisic Acid

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Monocyclic Sesquiterpenes; Sesquiterpenes

Results Point of Contact

• Title: Josep Bassaganya-Riera
• Organization: BioTherapeutics Inc

info@biotherapeuticsinc.com

(540)-218-2262

Study Officials

• Bret Goodpaster, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a randomized, cross-over, placebo-controlled trial will be employed to evaluate the effects of ABA (95ug) twice a day (190ug total per day) for 14 days on tolerability and insulin sensitivity during a hyperinsulinemic euglycemic clamp.

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 25, 2021
• Study Start: March 8, 2021
• Primary Completion: August 26, 2024
• Study Completion: December 1, 2025
• Last Updated: March 9, 2026
• Results First Posted: March 9, 2026

Record last verified: 2026-02

Locations

US (1)