Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT03872557
Eligibility Criteria:
i. Inclusion Criteria
1. Capable of giving written as well as oral informed consent.
2. A fasting plasma glucose level (FPG) \< 126 mg/dL (\< 7.0 mmol/L) and an Hb1ac in the 5.7-6.4 % range.
3. BMI in the range of 18-45 kg/m2.
4. Normal Complete blood count (CBC), renal and liver function tests.
ii. Exclusion Criteria:
1. Any diabetes medication within previous three (3) months.
2. Fasting plasma Glucose (FPG) \>126 mg/dl or HbA1c \> 6.4%
3. Current use (or within 6 months) of antipsychotic, anti-anxiety, or antidepressant medications (e.g. monoamine oxidase (MAO) inhibitors, 5-Hydroxytryptophan (5HT) inhibitors, tricyclic antidepressants, L-DOPA), reserpine, β-2-receptor agonists (e.g., terbutaline), steroids, weight loss medication, anticoagulant medication, over-the-counter nutritional supplements other than standard vitamin and mineral supplements
4. History of Phenylketonuria or other inherited disorders of amino acid metabolism.
5. History of movement disorder such as Parkinson's disease or Huntington's disease
6. Cardiovascular, renal, pulmonary, gastrointestinal, migraines or other medical conditions deemed significant by investigators
7. History of/ or psychiatric illness such as major depression, bipolar disease, anxiety or schizophrenia.
8. History of bariatric surgery with the exception of gastric band if the band has been removed
9. Female of child-bearing age, currently pregnant, breastfeeding or not using a form of birth control.
10. Previous or current use of cocaine, methamphetamine, ecstasy (3-4 methylenedioxymethamphetamine (MDMA))
11. Current daily intake of caffeine \>500 mg/day (\>4-5 cups of coffee; \>10 12-oz cans of soda)
12. Consumption of more than 1 alcoholic drink per day or smoking more than 5 cigarettes/day.
13. Systolic Blood Pressure (SBP) \> 150 mmHg; Diastolic Blood Pressure (DBP) \> 100 mmHg.
14. Recent history (in the past three months) of more than a 3% gain or loss in body wt.
15. Difficulty in swallowing capsules.
16. Concurrent use of antacids or proton pump inhibitors (e.g.,Prilosec Prevacid, dexilant, Aciphex, Protonix, Nexium, Vimovo, Zegerid)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03872557
Study Brief:
Protocol Section:
NCT03872557