GLYLO Supplement Pilot Trial on Glycation and Aging in Postmenopausal Women

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.

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.