GLYLO Supplement Pilot Trial on Glycation and Aging in Postmenopausal Women

Last updated: July 16, 2025
Sponsor: Buck Institute for Research on Aging
Overall Status: Active - Recruiting

Phase

N/A

Condition

Menopause

Treatment

Placebo

GLYLO

Clinical Study ID

NCT06813261
BUCK_2501
  • Ages 45-65
  • Female

Study Summary

The aim of this study is to assess the effectiveness of GLYLO, a dietary supplement, in postmenopausal women aged 45 to 65 who are overweight or obese and have elevated HbA1c levels. Specifically, the study seeks to evaluate whether GLYLO can reduce advanced glycation end products (AGEs) levels, which are harmful compounds formed when sugar attaches to proteins or fats in the body and can contribute to aging and disease. The primary outcome of the study is to determine if GLYLO reduces AGEs, enhances metabolic and hormonal health, and mitigates age-related functional decline.

This study includes one screening visit and three testing visits over a 6-month period. After eligibility is confirmed, participants will be randomly assigned to one of two groups to take either GLYLO (two capsules daily) or a placebo at home for 24 weeks. Participants will provide blood samples at every visit. During the three testing visits, they will complete physical performance and cognitive function tests, provide both blood and urine samples, and fill out quality of life and 24-hour dietary intake questionnaires. The dietary intake questionnaires will be completed only twice i.e. at the baseline visit and again at the final 6-month visit.

Eligibility Criteria

Inclusion

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 twodays and share with the study team if their weight at the screening visit results inthem 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 andunderstand instructions.

  7. Able to attend in-person visits at The Buck Institute

Exclusion

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 theingredients in GLYLO, within the last 3 months.

  7. Diabetes, T1DM or T2DM (self-report and screening tests): Treatment with anyhypoglycemic agents (self-report), fasting glucose >125 mg/dL (screening test; mayreassess 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 mayprovide home readings for two days if they do not meet this criterion at thescreening visit.

  9. Psychotropic and/or other medications known to significantly impact weight unless ona 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 beallowed under some conditions (e.g., recent use of acetaminophen).

  11. Immunosuppressive disorders, taking immunosuppressive medications (including oralprednisone >10mg/day and biological immunosuppressants), or receiving chemotherapy.

  12. Active gastrointestinal bleeding, or active bleeding diathesis (or resolved within 6months 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), exceptnon-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), currentabnormal thyroid function (blood test at screening).

  18. Cognitive status: Unable to provide informed consent to participate in and safelycomplete the protocol, as based on the judgment of the investigators (screeningvisit)

  19. Psychiatric status: any condition that might affect the ability to comply with theprotocol in the opinion of the Clinical Investigator or Medical Officer (screeningvisit)

  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 thatare 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 Investigatoror Medical Officer would compromise the safety of the patient or the quality of thedata

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
April 01, 2025
Estimated Completion Date:
June 30, 2026

Study Description

Telephone Screening: Subjects are screened for eligibility by telephone for major exclusion criteria. They then attend a screening visit. Eligible participants will receive an Informed Consent Form to review prior to the in-person screening visit.

Pre-Visit Requirements for all Visits: Fasting (water only) ≥10 hours, no alcohol, exercise, or cannabis products ≥10 hours.

Visit 1: Screening Visit

Upon arrival, participants will provide written consent before study procedures. A fasting blood sample will be collected for blood chemistry, hematology, lipid profile, HbA1c, and thyroid panel analysis. Participants will undergo measurements of height, weight, BMI, vital signs (blood pressure, heart rate, body temperature), and menopausal status. Medical history, current medications/supplements, and inclusion/exclusion criteria will be recorded. Eligibility will be confirmed within 2 weeks following a review by medical officers.

Visit 2: Baseline Visit Participants will undergo assessments of weight, waist/hip circumference, BMI, body composition (BIA), and vital signs. A fasting blood sample will be drawn for blood chemistry, hematology, lipids, HbA1c, and hormone panels (FSH, LH, E2, progesterone, testosterone). Additional blood will be stored for future analysis (MGO, AGEs, metabolomics, inflammation, phenotypic age). Participants will provide a midstream urine sample for archiving.

Physical Tests: Short Physical Performance Battery (SPPB), 6-minute walk test, handgrip strength.

Cognitive Tests: Montreal Cognitive Assessment (MoCA), Digit Symbol Substitution Task, Trails A & B.

Functional Tests: Skin autofluorescence (AGE Reader, DiagnOptics), Pulse Wave Velocity (PWV), retinal imaging.

Quality of life questionnaires: Pittsburgh Sleep Quality Index (PSQI), European Quality of Life 5 Dimensions (EQ-5D-5L).

Participants will receive GLYLO capsules for 12 weeks and instructions for use. They will also be provided with access to the Automated Self-administered 24-hour Dietary Assessment Tool (ASA24) and a wearable actigraphy device (Fitbit) to track activity.

At-Home Procedures Participants will take one capsule of GLYLO per day after their first meal for the first week, and two capsules per day from Week 2 onwards (after the first and last meals). They will complete a daily Study Log for 14 days, tracking product intake and symptoms. From Day 15, an abbreviated version will be used. Compliance will be monitored through telephonic interviews at Weeks 2, 4, 6, 8, 10, 14, 18, and 22. ASA24 diet logs will be completed during Weeks 1 and 23.

Visit 3: Interim Visit (3-Month Visit) Participants will return unused products and complete all assessments from the Baseline Visit. Compliance will be reviewed, and participants will receive GLYLO for an additional 12 weeks and a new Study Log.

Visit 4: Final Visit (6-Month Visit) Participants will return unused products and repeat all assessments from the Baseline and Interim Visits. They will not receive additional study products at this visit. Participants will be asked to guess the treatment they received to assess blinding.

Connect with a study center

  • The Buck Institute for Research on Aging

    Novato, California 94945
    United States

    Active - Recruiting

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