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 @ 12:19 PM
Ignite Modification Date:
2025-12-24 @ 12:19 PM
NCT ID:
NCT06813261
Eligibility Criteria:
Inclusion Criteria:
1. Adults identified as female at birth with ovaries present (self-report)
2. Post menopause \>1y since last menses (self-report)
3. Aged 45 - 65 y
4. Anthropometric criteria (either of the following must be met):
* BMI ≥ 25 kg/m², based on self-reported weight and height
* OR Waist circumference ≥88 cm, based on self-measured values. Participants may provide average home weight measurements over two consecutive days if their BMI at the screening visit is slightly below 25 kg/m².
5. HbA1c 5.5- 6.4% (screening measurement)
6. Able to read and speak English well enough to provide informed consent and understand instructions.
7. Able to attend in-person visits at The Buck Institute
Exclusion Criteria:
1. Surgical menopause (self-report)
2. Hysterectomy and/or ovariectomy (self-report)
3. Receiving systematic hormone replacement therapy (HRT) (self-report). Use of local vaginal estrogen therapy (e.g., estrogen creams, vaginal tablets, or estrogen rings such as Estring) is permitted.
4. Currently prescribed or received weight loss medications within the past 6 months or currently enrolled in a defined weight loss program. Weight must be stable (\> 4%) within the last 3 months.
5. Regular use of GLYLO, or regular use of a supplement containing any of the ingredients in GLYLO, within the last 3 months.
6. Diabetes, T1DM or T2DM (self-report and screening tests): Treatment with any hypoglycemic agents (self-report), fasting glucose \>125 mg/dL (screening test; may reassess once), current use of hypoglycemic drugs for non-diabetic reasons (self-report).
7. Elevated blood pressure readings (screening test): Resting Systolic Blood Pressure (SBP) ≥180 mmHg or resting Diastolic Blood Pressure (DBP) ≥100 mmHg. If a participant's blood pressure is elevated at the screening visit but not consistent with this threshold, they may provide home blood pressure readings (twice daily for two consecutive days) for the study team to evaluate eligibility.
8. Psychotropic and/or other medications known to significantly impact weight unless on a stable dose for ≥ 6 months (self-report).
9. Liver enzyme tests (alanine transaminase, aspartate transaminase) (screening test): \>2 times the laboratory upper limit of normal. Reassessment during screening may be allowed under some conditions (e.g., recent use of acetaminophen).
10. Immunosuppressive disorders, taking immunosuppressive medications (including oral prednisone \>10mg/day and biological immunosuppressants), or receiving chemotherapy.
11. Active gastrointestinal bleeding, or active bleeding diathesis (or resolved within 6 months prior to randomization) (self-report)
12. Active peptic ulcer disease (or resolved within 6 months prior to randomization) (self-report)
13. Active malignancy (or resolved within 6 months prior to randomization), except non-melanoma skin cancer not undergoing treatment (self-report).
14. Active infection (or resolved within 1 month prior to randomization) (self-report)
15. Allergy or hypersensitivity to any component of the supplement (self-report)
16. History of hyperthyroidism or thyroid cancer(self-report), current abnormal thyroid function (blood test at screening).
17. Cognitive status: Unable to provide informed consent to participate in and safely complete the protocol, as based on the judgment of the investigators (screening visit)
18. Psychiatric status: any condition that might affect the ability to comply with the protocol in the opinion of the Clinical Investigator or Medical Officer (screening visit)
19. Active eating disorders (self-report).
20. Active diagnosis of Gout (self-report)
21. Any change to prescription medications within 3 months prior to randomization that are judged by the study physician to impact the results of the study (self-report)
22. No overnight hospitalization within 1 month prior to randomization (self-report)
23. The presence of a condition or abnormality that in the opinion of the Investigator or Medical Officer would compromise the safety of the patient or the quality of the data
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
65 Years
Study:
NCT06813261
Study Brief:
Protocol Section:
NCT06813261