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| Name | Class |
|---|---|
| BioTherapeutics Inc. | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABA group | Active Comparator | 95 ug 2x/day for 14 days |
|
| Placebo group | Placebo Comparator | Corn Starch 300 mg for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Bret Goodpaster, PhD | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AdventHealth Translational Research Institute | Orlando | Florida | 32803 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active, Then Placebo | Participants first received ABA 95 ug 2x/day for 14 days. After a washout period of 4 weeks, they then received Placebo 2x/day for 14 days. |
| FG001 | Placebo, Then Active | Participants first received placebo 2x/day for 14 days. After a washout period of 4 weeks, they then received ABA 95 ug 2x/day for 14 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Partcipants | All subjects randomized into the trial. All participants were randomized to receive all interventions in a crossover design |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Monitoring Adverse Events | Adverse events will be monitored at each visit throughout the duration of the study. | Posted | Number | TEAE | 10 weeks |
|
|
From enrollment until end of follow-up, up to 12 weeks
TEAE
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ABA Group | 95 ug 2x/day for 14 days | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Josep Bassaganya-Riera | BioTherapeutics Inc | (540)-218-2262 | info@biotherapeuticsinc.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 9, 2023 | Jan 26, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000040 | Abscisic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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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.
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|
| 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) |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
|
| Primary | Insulin Sensitivity | Rate of glucose disposal, measured by hyperinsulinic euglycemic clamp, normalized to pre-treatment baseline (mg/min) | Posted | Mean | Standard Deviation | ratio to baseline | After 2 weeks of treatment |
|
|
|
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Placebo Group | Corn Starch 300 mg for 14 days | 0 | 5 | 0 | 5 | 0 | 5 |
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| D002338 |
| Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D000081222 | Monocyclic Sesquiterpenes |
| D012717 | Sesquiterpenes |