GLYLO supplement to lower glycation and support healthy aging in postmenopausal women

A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Pilot Trial Investigating the Impact of a Glycation Lowering (GLYLO) Supplement on Geroscience Outcomes in Postmenopausal Women

This study tests whether taking GLYLO capsules for 24 weeks can lower harmful advanced glycation end products (AGEs) and improve metabolic and hormonal health in overweight or obese postmenopausal women aged 45–65 with mildly elevated HbA1c.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 45 Years to 65 Years
• Sex: Female
• Sponsor: Buck Institute for Research on Aging (Academic / other)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 1 site (Novato, California)
• Trial ID: NCT06813261 on ClinicalTrials.gov

What this trial studies

This randomized, placebo-controlled pilot enrolls postmenopausal women aged 45–65 who are overweight or obese with HbA1c 5.5–6.4% and randomizes them to GLYLO or placebo for 24 weeks. Participants complete one screening visit and three in-person testing visits over six months with fasting blood draws at each visit and storage of additional samples for AGE and metabolomic analyses. Physical performance (SPPB, 6-minute walk, handgrip) and cognitive tests are performed at testing visits to track functional and cognitive changes. The primary focus is change in AGE levels with secondary outcomes including metabolic, hormonal, inflammatory markers, and measures of physical and cognitive function.

Who should consider this trial

Good fit: Ideal candidates are adults identified female at birth who are >1 year postmenopausal, aged 45–65, with BMI ≥25 kg/m² or waist ≥88 cm, HbA1c 5.5–6.4%, not on systemic hormone therapy, English-speaking, and able to attend in-person visits at the Buck Institute in Novato, CA.

Not a fit: People who had surgical menopause or ovariectomy, are currently on systemic hormone replacement therapy, are outside the age or HbA1c ranges, or who are unable to attend the Buck Institute visits are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, GLYLO could reduce AGEs and improve metabolic, hormonal, and functional measures, potentially slowing aspects of biological aging in this group.

How similar studies have performed: Some preclinical and small clinical studies of AGE-targeting supplements and drugs have shown promise, but large randomized trials demonstrating clear clinical benefit are limited.

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

Where this trial is running

Novato, California

• The Buck Institute for Research on Aging — Novato, California, United States (Recruiting)

Study contacts

• Study coordinator: Brianna Stubbs, DPhil

Conditions Postmenopause; Metabolism; Geroscience; Dietary supplement; Healthy aging; Women's health; Hormones; Advanced glycation end products