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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT06445569
Eligibility Criteria:
Inclusion Criteria:
1. Healthy adult participants who are at least 50 years of age (inclusive) at the time of signing the informed consent form.
2. Have a body mass index (BMI) between 25.0 to 45.0 kg/m2 (inclusive).
3. In good general health and good oral health (no active or uncontrolled diseases, infections or conditions).
4. Impaired glucose metabolism evidence by either fasting glucose of 100 to 125 mg/dL at screening or an HbA1c between 5.7 and 6.4%.
5. Female participants of childbearing potential (i.e., participants who are not surgically sterilized or not post-menopausal (defined as amenorrhea for greater than 1 year), or transgendered males with retained ovaries and uterus) must agree to use a medically approved method of birth control for at least one month prior (or three months prior in the case of oral or long-acting injective contraceptives) to the first dose of study product and throughout the study, or abstain from heterosexual intercourse throughout the duration of the study and have a negative urine pregnancy result at baseline. For males of reproductive potential: use of condoms, abstinence from heterosexual intercourse, or other methods to ensure that their partners (if able) do not become pregnant during the course of the study.
6. Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.
Exclusion criteria:
1. Participant has a medical history of uncontrolled hypertension (i.e., ≥160 mmHg systolic and/or ≥100 mmHg diastolic)
2. Participant has a medical history of heart disease and/or cardiovascular disease, kidney disease (dialysis or renal failure), hepatic impairment or disease, or Type 1 or Type 2 diabetes.
3. Participant has a medical history of unstable thyroid disease, previously diagnosed major affective disorder, psychiatric disorder that required hospitalization in the year prior to screening, immune disorder (i.e., HIV/AIDS), or a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to screening visit.
4. Female participants who are lactating, pregnant, or planning to become pregnant during the study.
5. Have a known intolerance, sensitivity, or allergy to any of the study products or their ingredients, or any of the excipients used in the formulation.
6. Have a known intolerance, sensitivity, or allergy to milk.
7. Unable to be prescribed at least one of the antibiotics outlined in the study protocol.
8. Any condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the participant or the quality of the study data.
9. Currently taking dietary supplements other than vitamins (a 14-day washout period prior to baseline/Visit 2 would be permitted).
10. Taking any prescription medication at the time of randomization that is known to impact blood sugar and or blood sugar metabolism, as per Principal Investigator's (PI) discretion.
11. Use of certain medications in timeframes defined in the study protocol (Ampicillin, Gentamicin, Kanamycin, Streptomycin, Erythromycin, Clindamycin, Tetracycline, Chloramphenicol, Potassium sparing diuretics, Nitroglycerin and other nitrates, antidiabetic/Blood sugar lowering medications, any blood thinning medications (i.e., anticoagulant/antiplatelet drugs), antidepressants (use is permitted if dosage is maintained throughout the study), anxiolytics, antipsychotics , anticholinergics/antispasmodics, calcium-channel blockers (use is permitted if dosage is maintained throughout the study), Opioids.
12. Use of supplements dietary supplements/food/drink within 2 weeks or 7 half-lives (whichever is longer) prior to baseline and for the duration of the study, including foods/drinks rich in probiotics or prebiotics (e.g., yogurt, sauerkraut, kombucha) or synbiotics, Any herbs and supplements with hypoglycemic potential, any herbs or supplements that induce weight loss, any blood sugar lowering herbs or supplements, any blood thinning herbs or supplements
13. History of alcohol or substance abuse in the 12 months prior to screening.
14. Receipt or use of an investigational product in another research study within 28 days prior to baseline/Visit 2.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT06445569
Study Brief:
Protocol Section:
NCT06445569