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 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
NCT ID:
NCT05887050
Eligibility Criteria:
Inclusion Criteria:
* Provide voluntary signed and dated informed consent.
* Be in good health as determined by medical history and routine blood chemistries.
* Age between the ages of 21 and 65 (inclusive).
* Body Mass Index of 18.5-34.99 (inclusive).
* Body weight of at least 120 pounds.
* Fasting blood sugar of 100-125 (inclusive) OR HgA1c of 5.7-6.4% (inclusive).
* Normotensive (seated, resting systolic blood pressure \<140 mm Hg and diastolic blood pressure \< 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
* Normal seated, resting heart rate (\<90 per minute).
* Willing to duplicate their previous 24-hour diet, refrain from caffeine for 12 hrs and exercise
Exclusion Criteria:
* History of unstable or new-onset cardiovascular or cardiorespiratory disease.
* History of diabetes, or other endocrine disorder.
* Fasting blood sugar of \> 125 mg/dL or HgA1c of \> 6.4%.
* History of use of medications or dietary supplements known to affect glycemia or insulinemia.
* History of hyperparathyroidism or an untreated thyroid disease.
* History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
* Prior gastrointestinal bypass surgery (Lapband), etc.
* Other known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism, e.g. short bowel syndrome, diarrheal illnesses, history of colon resection, gastro paresis, Inborn-Errors-of-Metabolism (such as PKU).
* Chronic inflammatory condition or disease (e.g. rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, HIV/AIDS, etc.).
* Known sensitivity to any ingredient in the test formulations as listed in the Certificates-of-Analysis.
* Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.
* Any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT05887050
Study Brief:
Protocol Section:
NCT05887050