CompletedNCT04722354ABAUpdated Mar 9, 2026Results posted

Abscisic Acid Effects on Glucose Homeostasis and Insulin Sensitivity

A Phase 2 interventional study of Hyperinsulemic euglycemic clamp and Muscle Biopsy in Pre Diabetes, sponsored by AdventHealth Translational Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-09.

Sponsored by AdventHealth Translational Research Institute · Phase 2, Interventional, and Other

Phase: Phase 2
Study type: Interventional
Enrollment: 5
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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 studied

Pre Diabetes

Browse trials for

Glucose Intolerance 778

Keywords

metabolism

In context

Glucose Intolerance

778 studies on the registry are indexed under Glucose Intolerance; 129 are open to participants now.

This study's enrollment of 5 is below the median of 60 across 645 interventional studies indexed under Glucose Intolerance.

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Lead sponsor

AdventHealth Translational Research Institute is the lead sponsor of 57 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Phase 2
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Single (Participant)
Enrollment: 5 participants (actual)

Study arms

Active comparator
ABA group
95 ug 2x/day for 14 days
Other: Hyperinsulemic euglycemic clamp · Procedure: Muscle Biopsy · Dietary Supplement: Oral abscisic acid (ABA)
Placebo comparator
Placebo group
Corn Starch 300 mg for 14 days
Other: Hyperinsulemic euglycemic clamp · Procedure: Muscle Biopsy · Other: Placebo

Interventions

OtherHyperinsulemic 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.
ProcedureMuscle 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 supplementOral abscisic acid (ABA)
Those in this group will receive ABA (95 µg ABA and 300 mg of corn starch)
OtherPlacebo
Those in this group will receive placebo (300 mg cornstarch)

What researchers measure

Primary outcomes

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

Results

Posted Mar 9, 2026

Participant flow

Participant flow — Overall Study
Milestone	Active, Then Placebo	Placebo, Then Active
Started	2	3
Completed	2	3
Not completed	0	0

Outcome measures

PrimaryMonitoring Adverse Events

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

Time frame:: 10 weeks
Reported as:: Number · TEAE

Monitoring Adverse Events
TEAE	ABA Group	Placebo Group
Monitoring Adverse Events	0	0

PrimaryInsulin Sensitivity

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

Time frame:: After 2 weeks of treatment
Reported as:: Mean · ratio to baseline

Insulin Sensitivity
ratio to baseline	ABA Group	Placebo Group
Insulin Sensitivity	1.173 ± 0.292	0.905 ± 0.075

Adverse events

Collected over From enrollment until end of follow-up, up to 12 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
ABA Group	0/5 (0%)	0/5 (0%)	0/5 (0%)
Placebo Group	0/5 (0%)	0/5 (0%)	0/5 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	All Study Partcipants
Mean	63 (48 to 71)

Sex: Female, Male
Sex: Female, Male(Participants)	All Study Partcipants
Female	3
Male	2

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	All Study Partcipants
Hispanic or Latino	2
Not Hispanic or Latino	3
Unknown or Not Reported	0

Study locations

1 site

AdventHealth Translational Research Institute
Orlando, Florida 32803, United States

References and documents

Study documents

Protocol and statistical analysis plan · Feb 9, 2023

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04722354
Lead sponsor: AdventHealth Translational Research Institute
Collaborators: BioTherapeutics Inc.
Responsible party: Sponsor
First posted: Jan 25, 2021
Start date: Mar 8, 2021
Primary completion: Aug 26, 2024
Completion: Dec 1, 2025
Results posted: Mar 9, 2026
Last update: Mar 9, 2026

Study contacts

Bret Goodpaster, PhD

principal investigator · Principal Investigator

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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