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New treatment option for Postmenopause
Official title GLYLO Supplement Pilot Trial on Glycation and Aging in Postmenopausal Women
ClinicalTrials.gov ID: NCT06813261
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 65, women only
You may be able to join if
- 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
You likely can't join if
- 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...
- Currently prescribed or received weight loss medications within the past 6 months or currently enrolled in a defined weight loss program. Weight must...
- 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...
See the full eligibility 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):
- 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
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Novato, California, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 45 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Novato, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.