Phase 2
N=5
Abscisic Acid Effects on Glucose Homeostasis and Insulin Sensitivity
Pre Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT04722354 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Monitoring Adverse Events — 0; 0 TEAE
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Hyperinsulemic euglycemic clamp (Other); Muscle Biopsy (Procedure); Oral abscisic acid (ABA) (Dietary_supplement); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AdventHealth Translational Research Institute
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Monitoring Adverse Events |
0; 0 | — |
| PRIMARY Insulin Sensitivity |
1.173; 0.905 | — |
Summary
The purpose of this study is to determine the effects of oral abscisic acid (ABA) on glucose metabolism in subjects with defined prediabetes.
Eligibility Criteria
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 or exhibiting
- Fasting glucose >5.6 and 5.6 and 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.
Data sourced from ClinicalTrials.gov (NCT04722354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.