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OpenTrials
Completed

NCT Number: NCT04722354

Abscisic Acid Effects on Glucose Homeostasis and Insulin Sensitivity

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

AdventHealth Translational Research Institute

Orlando, Florida, 32803, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Treated or untreated diabetes
  • 19>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.

Treatment and study plan

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.

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.

Oral abscisic acid (ABA)

Dietary Supplement

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

Placebo

Other

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

Primary outcomes

  1. Monitoring Adverse Events

    Time frame: 10 weeks

    Adverse events will be monitored at each visit throughout the duration of the study.

  2. Insulin Sensitivity

    Time frame: After 2 weeks of treatment

    Rate of glucose disposal, measured by hyperinsulinic euglycemic clamp, normalized to pre-treatment baseline (mg/min)

Sponsors and collaborators

Lead sponsor

AdventHealth Translational Research Institute

Other

Collaborators

  • BioTherapeutics Inc.

Registry information

Acronym: ABA

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jan 25, 2021
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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