GLYLO Supplement Pilot Trial on Glycation and Aging in Postmenopausal Women

NCT06813261 | Recruiting

• 1 other identifier: BUCK_2501
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postmenopause; Metabolism; Geroscience

Keywords

Dietary supplement; Healthy aging; Women's health; Hormones; Advanced glycation end products (AGEs); Glycation stress; Metabolic stress

Outcome Measures

Primary Outcomes (2)

• 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

  Baseline, Week 12, Week 24

• 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

  Baseline, Week 12, Week 24

Secondary Outcomes (8)

• Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

  Baseline, Week 12, Week 24

• HbA1c

  Baseline, Week 12, Week 24

• Body fat

  Baseline, Week 12, Week 24

• Body mass index (BMI)

  Baseline, Week 12, Week 24

• Hip circumference

  Baseline, Week 12, Week 24

Other Outcomes (13)

• Retinal age

  Baseline, Week 12, Week 24

• Pulse wave velocity (PWV)

  Baseline, Week 12, Week 24

• Skin autofluorescence for measuring AGEs

  Baseline, Week 12, Week 24

Study Arms (2)

GLYLO

EXPERIMENTAL

a 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.

Other: GLYLO

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

GLYLO OTHER

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.

GLYLO

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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

You may not qualify 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, 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)

Sponsors & Collaborators

• Buck Institute for Research on Aging: lead

Study Sites (1)

The Buck Institute for Research on Aging

Novato, California, 94945, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 24688308 BACKGROUND

• 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.

  PMID: 24491162 BACKGROUND

• 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.

  PMID: 30184484 BACKGROUND

Central Study Contacts

Brianna Stubbs, DPhil

CONTACT

415-209-2000; bstubbs@buckinstitute.org

Vineeta Tanwar, PhD

CONTACT

415-209-2072; vtanwar@buckinstitute.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: February 6, 2025
• Study Start: April 1, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

US (1)