GLYLO Supplement Pilot Trial on Glycation and 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
Buck Institute for Research on Aging
30 participants
Apr 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- Adults identified as female at birth with ovaries present (self-report)
- Post menopause \>1y since last menses (self-report)
- Aged 45 - 65 y
- 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.
- HbA1c 5.5- 6.4% (screening measurement)
- Able to read and speak English well enough to provide informed consent and understand instructions.
- Able to attend in-person visits at The Buck Institute
Exclusion Criteria23
- Surgical menopause (self-report)
- Hysterectomy and/or ovariectomy (self-report)
- 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.
- 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.
- Regular use of GLYLO, or regular use of a supplement containing any of the ingredients in GLYLO, within the last 3 months.
- 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).
- 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.
- Psychotropic and/or other medications known to significantly impact weight unless on a stable dose for ≥ 6 months (self-report).
- 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).
- Immunosuppressive disorders, taking immunosuppressive medications (including oral prednisone \>10mg/day and biological immunosuppressants), or receiving chemotherapy.
- Active gastrointestinal bleeding, or active bleeding diathesis (or resolved within 6 months prior to randomization) (self-report)
- Active peptic ulcer disease (or resolved within 6 months prior to randomization) (self-report)
- Active malignancy (or resolved within 6 months prior to randomization), except non-melanoma skin cancer not undergoing treatment (self-report).
- Active infection (or resolved within 1 month prior to randomization) (self-report)
- Allergy or hypersensitivity to any component of the supplement (self-report)
- History of hyperthyroidism or thyroid cancer(self-report), current abnormal thyroid function (blood test at screening).
- 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)
- 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)
- Active eating disorders (self-report).
- Active diagnosis of Gout (self-report)
- 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)
- No overnight hospitalization within 1 month prior to randomization (self-report)
- 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
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Interventions
commercially available combination of glycation-lowering compounds that are GRAS (generally recognized as safe) by the FDA. GLYLO Ingredients Benfotiamine (fat-soluble Vitamin B1 derivative)-100mg Vitamin B6 (Pyridoxine Hydrochloride)-50mg Nicotinamide-200mg Alpha Lipoic Acid-150mg Piperine-10mg For the first week, one GLYLO capsule daily, 5 minutes after the first meal. From week 2 onwards, two capsules of GLYLO daily, one capsule after the first meal and a second capsule after the last meal.
Visually matched capsule with microcrystalline cellulose as an inert ingredient. For the first week, one placebo capsule daily, 5 minutes after the first meal. From week 2 onwards, two capsules of the placebo daily, one capsule after the first meal and a second capsule after the last meal.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06813261