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PostmenopauseGRACENCT06813261

GLYLO Supplement Pilot Trial on Glycation and Aging in Postmenopausal Women

A study testing GLYLO in people with Postmenopause and Metabolism, run by Buck Institute for Research on Aging at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 65 years, women only
Conditions the study is for
Postmenopause, Metabolism, Geroscience
What is being tested?
GLYLO
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteUnited States
Study dates
1 Apr 2025to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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).
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Brianna Stubbs, DPhil contact

415-209-2000 ext. 6709

bstubbs@buckinstitute.org

Vineeta Tanwar, PhD contact

415-209-2072

vtanwar@buckinstitute.org

United States1 site, 1 recruiting

  • The Buck Institute for Research on Aging

    Novato, California, 94945

    Vineeta Tanwar, PhD, (415) 209-2072, vtanwar@buckinstitute.org

    Chatura Senadheera, MSc, 4152092072, csenadheera@buckinstitute.org

    Recruiting

Other trials in United States

About this study

Official title: 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

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.

Read the detailed 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.

Being tested
GLYLO, Placebo
Keywords
Dietary supplement, Healthy aging, Women's health, Hormones, Advanced glycation end products (AGEs), Glycation stress, Metabolic stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GLYLOOther

    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.

  • PlaceboOther

    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.

Study groups in NCT06813261
Study groupRoleWhat they receive
GLYLOExperimentala 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.
Receives: Other: GLYLO
PlaceboPlacebo comparatorVisually 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.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Methylglyoxal (MGO)

    MGO is a reactive dicarbonyl compound, measured by biochemical assays such as high-performance liquid chromatography (HPLC) or liquid chromatography-mass spectrometry (LC-MS) . The concentration of MGO is quantified to assess its role in the formation of advanced glycation end products (AGEs). Change is measured across the study

    Measured: Baseline, Week 12, Week 24

  2. Advance glycation end products (AGE)

    Measurement of circulating and tissue-bound AGE will be measure by either HPLC or LC-MS. Change is measured across the study

    Measured: Baseline, Week 12, Week 24

Secondary outcomes (8)

  1. Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

    This is calculated by the formula HOMA-IR = (Fasting Insulin * Fasting Glucose) / 405, using fasting glucose and insulin levels. It is a marker of insulin resistance, reflecting metabolic health. Change is measured across the study

    Measured: Baseline, Week 12, Week 24

  2. HbA1c

    HbA1c is measured through immunoassay techniques, indicating average blood glucose levels over the previous 2-3 months, which is a crucial marker for long-term glucose control. Change is measured across the study

    Measured: Baseline, Week 12, Week 24

  3. Body fat

    Bioelectrical impedance analysis (BIA) is used to assess body composition, measuring fat mass. BIA calculates resistance and reactance, allowing for an estimate of body fat and lean tissue. Change is measured across the study

    Measured: Baseline, Week 12, Week 24

  4. Body mass index (BMI)

    Calculation of BMI by dividing weight (kg) by height (m²). Change is measured across the study

    Measured: Baseline, Week 12, Week 24

  5. Hip circumference

    Hip circumference is measured using a flexible tape measure, usually in centimeters, to assess fat distribution and identify central obesity, which is a risk factor for metabolic and cardiovascular diseases. Change is measured across the study

    Measured: Baseline, Week 12, Week 24

  6. Follicle-stimulating hormone (FSH)

    FSH levels are measured using immunoassays such as ELISA or radioimmunoassay, which quantify the concentration of this hormone in the blood to assess ovarian function and reproductive aging. Change is measured across the study

    Measured: Baseline, Week 12, Week 24

  7. Muscle mass

    Bioelectrical impedance analysis (BIA) is used to assess body composition, measuring lean muscle mass. BIA calculates resistance and reactance, allowing for an estimate of body fat and lean tissue. Change is measured across the study

    Measured: Baseline, Week 12, Week 24

  8. Waist circumference

    Waist circumference is measured using a flexible tape measure, usually in centimeters, to assess fat distribution and identify central obesity, which is a risk factor for metabolic and cardiovascular diseases. Change is measured across the study

    Measured: Baseline, Week 12, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2025
  2. Study start1 Apr 2025
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06813261
Sponsor's protocol ID
BUCK_2501
Acronym
GRACE
Status last verified
Sep 2025
First submitted
13 Jan 2025
Last updated
8 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Yang DH, Chiang TI, Chang IC, Lin FH, Wei CC, Cheng YW. Increased levels of circulating advanced glycation end-products in menopausal women with osteoporosis. Int J Med Sci. 2014 Mar 13;11(5):453-60. doi: 10.7150/ijms.8172. eCollection 2014.

    PubMed 24688308

  • Merhi Z. Advanced glycation end-products: pathway of potentially significant pathophysiological and therapeutic relevance for metabolic syndrome in menopausal women. J Clin Endocrinol Metab. 2014 Apr;99(4):1146-8. doi: 10.1210/jc.2013-4465. Epub 2014 Feb 3. No abstract available.

    PubMed 24491162

  • Chaudhuri J, Bains Y, Guha S, Kahn A, Hall D, Bose N, Gugliucci A, Kapahi P. The Role of Advanced Glycation End Products in Aging and Metabolic Diseases: Bridging Association and Causality. Cell Metab. 2018 Sep 4;28(3):337-352. doi: 10.1016/j.cmet.2018.08.014.

    PubMed 30184484

  • Tanwar V, Kapahi P, Newman JC, Stubbs B. Reduction of glycation stress as a geroscience intervention: protocol for a pilot RCT in postmenopausal women. NPJ Aging. 2026 Apr 23;12(1):91. doi: 10.1038/s41514-026-00373-x.

    PubMed 42026060

Questions about this trial

What is this clinical trial studying?

A study testing GLYLO in people with Postmenopause and Metabolism, run by Buck Institute for Research on Aging at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Brianna Stubbs, DPhil (415-209-2000 ext. 6709, bstubbs@buckinstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Methylglyoxal (MGO) (time frame: Baseline, Week 12, Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06813261, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.

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