GLYLO Supplement Pilot Trial on Glycation and Aging in Postmenopausal Women (NCT06813261) | Clinical Trial Compass
RecruitingNot Applicable
GLYLO Supplement Pilot Trial on Glycation and Aging in Postmenopausal Women
United States30 participantsStarted 2025-04-01
Plain-language 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.
Who can participate
Age range45 Years – 65 Years
SexFEMALE
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Inclusion criteria
✓. 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):
✓. 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
✕. 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).