GLYLO Supplement Pilot Trial on Glycation and Aging in Postmenopausal Women

Launched by BUCK INSTITUTE FOR RESEARCH ON AGING · Feb 3, 2025

Keywords

ClinConnect Summary

The GLYLO Supplement Pilot Trial is a research study looking at how a dietary supplement called GLYLO may help postmenopausal women aged 45 to 65 who are overweight or obese. The main goal is to see if GLYLO can lower levels of harmful compounds called advanced glycation end products (AGEs) in the body, which can be linked to aging and various health issues. To participate, women need to be postmenopausal for at least a year, have a body mass index (BMI) of 27 or higher, and show certain blood sugar levels.

If eligible, participants will take either GLYLO or a placebo (a dummy pill) for six months while attending a few visits to the research center. During these visits, they will provide blood samples, complete tests related to physical performance and thinking abilities, and fill out questionnaires about their health and diet. It's important to note that certain health conditions and medications may prevent someone from participating in the study. Overall, this trial aims to explore how GLYLO could support better health in postmenopausal women.

Gender

FEMALE

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. BMI ≥ 27 (screening measurement). Participants may weigh themselves at home for two days and share with the study team if their weight at the screening visit results in them being slightly under the BMI cut-off.
• • 5. HbA1c 5.7- 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. Not identified as female at birth (self-report)
• • 2. Surgical menopause (self-report)
• • 3. Hysterectomy and/or ovariectomy (self-report)
• • 4. Receiving hormone replacement therapy (HRT) (self-report).
• • 5. 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.
• • 6. Regular use of GLYLO, or regular use of a supplement containing any of the ingredients in GLYLO, within the last 3 months.
• • 7. 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).
• • 8. Elevated blood pressure readings (screening test): Resting Systolic Blood Pressure (SBP) ≥150 mmHg or resting Diastolic Blood Pressure (DBP) ≥90 mmHg. Participants may provide home readings for two days if they do not meet this criterion at the screening visit.
• • 9. Psychotropic and/or other medications known to significantly impact weight unless on a stable dose for ≥ 6 months (self-report).
• • 10. 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).
• • 11. Immunosuppressive disorders, taking immunosuppressive medications (including oral prednisone \>10mg/day and biological immunosuppressants), or receiving chemotherapy.
• • 12. Active gastrointestinal bleeding, or active bleeding diathesis (or resolved within 6 months prior to randomization) (self-report)
• • 13. Active peptic ulcer disease (or resolved within 6 months prior to randomization) (self-report)
• • 14. Active malignancy (or resolved within 6 months prior to randomization), except non-melanoma skin cancer not undergoing treatment (self-report).
• • 15. Active infection (or resolved within 1 month prior to randomization) (self-report)
• • 16. Allergy or hypersensitivity to any component of the supplement (self-report)
• • 17. History of hyperthyroidism or current use of thyroid hormones (self-report), current abnormal thyroid function (blood test at screening).
• • 18. 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)
• • 19. 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)
• • 20. Active eating disorders (self-report).
• • 21. Active diagnosis of Gout (self-report)
• • 22. 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)
• • 23. No overnight hospitalization within 1 month prior to randomization (self-report)
• • 24. 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