RECRUITING

GLYLO Supplement Pilot Trial on Glycation and Aging in Postmenopausal Women

Conditions

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

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-04-01

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06813261

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 65 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Adults identified as female at birth with ovaries present (self-report) 2. Post menopause \>1y since last menses (self-report) 3. Aged 45 - 65 y 4. BMI ≥ 27 (screening measurement). Participants may weigh themselves at home for two days and share with the study team if their weight at the screening visit results in them being slightly under the BMI cut-off. 5. HbA1c 5.7- 6.4% (screening measurement) 6. Able to read and speak English well enough to provide informed consent and understand instructions. 7. Able to attend in-person visits at The Buck Institute	1. Not identified as female at birth (self-report) 2. Surgical menopause (self-report) 3. Hysterectomy and/or ovariectomy (self-report) 4. Receiving hormone replacement therapy (HRT) (self-report). 5. 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. 6. Regular use of GLYLO, or regular use of a supplement containing any of the ingredients in GLYLO, within the last 3 months. 7. 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). 8. Elevated blood pressure readings (screening test): Resting Systolic Blood Pressure (SBP) ≥150 mmHg or resting Diastolic Blood Pressure (DBP) ≥90 mmHg. Participants may provide home readings for two days if they do not meet this criterion at the screening visit. 9. Psychotropic and/or other medications known to significantly impact weight unless on a stable dose for ≥ 6 months (self-report). 10. 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). 11. Immunosuppressive disorders, taking immunosuppressive medications (including oral prednisone \>10mg/day and biological immunosuppressants), or receiving chemotherapy. 12. Active gastrointestinal bleeding, or active bleeding diathesis (or resolved within 6 months prior to randomization) (self-report) 13. Active peptic ulcer disease (or resolved within 6 months prior to randomization) (self-report) 14. Active malignancy (or resolved within 6 months prior to randomization), except non-melanoma skin cancer not undergoing treatment (self-report). 15. Active infection (or resolved within 1 month prior to randomization) (self-report) 16. Allergy or hypersensitivity to any component of the supplement (self-report) 17. History of hyperthyroidism or current use of thyroid hormones (self-report), current abnormal thyroid function (blood test at screening). 18. 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) 19. 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) 20. Active eating disorders (self-report). 21. Active diagnosis of Gout (self-report) 22. 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) 23. No overnight hospitalization within 1 month prior to randomization (self-report) 24. 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

Inclusion Criteria

Exclusion Criteria

1. Adults identified as female at birth with ovaries present (self-report)
2. Post menopause \>1y since last menses (self-report)
3. Aged 45 - 65 y
4. BMI ≥ 27 (screening measurement). Participants may weigh themselves at home for two days and share with the study team if their weight at the screening visit results in them being slightly under the BMI cut-off.
5. HbA1c 5.7- 6.4% (screening measurement)
6. Able to read and speak English well enough to provide informed consent and understand instructions.
7. Able to attend in-person visits at The Buck Institute

1. Not identified as female at birth (self-report)
2. Surgical menopause (self-report)
3. Hysterectomy and/or ovariectomy (self-report)
4. Receiving hormone replacement therapy (HRT) (self-report).
5. 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.
6. Regular use of GLYLO, or regular use of a supplement containing any of the ingredients in GLYLO, within the last 3 months.
7. 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).
8. Elevated blood pressure readings (screening test): Resting Systolic Blood Pressure (SBP) ≥150 mmHg or resting Diastolic Blood Pressure (DBP) ≥90 mmHg. Participants may provide home readings for two days if they do not meet this criterion at the screening visit.
9. Psychotropic and/or other medications known to significantly impact weight unless on a stable dose for ≥ 6 months (self-report).
10. 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).
11. Immunosuppressive disorders, taking immunosuppressive medications (including oral prednisone \>10mg/day and biological immunosuppressants), or receiving chemotherapy.
12. Active gastrointestinal bleeding, or active bleeding diathesis (or resolved within 6 months prior to randomization) (self-report)
13. Active peptic ulcer disease (or resolved within 6 months prior to randomization) (self-report)
14. Active malignancy (or resolved within 6 months prior to randomization), except non-melanoma skin cancer not undergoing treatment (self-report).
15. Active infection (or resolved within 1 month prior to randomization) (self-report)
16. Allergy or hypersensitivity to any component of the supplement (self-report)
17. History of hyperthyroidism or current use of thyroid hormones (self-report), current abnormal thyroid function (blood test at screening).
18. 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)
19. 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)
20. Active eating disorders (self-report).
21. Active diagnosis of Gout (self-report)
22. 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)
23. No overnight hospitalization within 1 month prior to randomization (self-report)
24. 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

Contacts and Locations

Study Contact

Brianna Stubbs, DPhil

CONTACT

415-209-2000

bstubbs@buckinstitute.org

Vineeta Tanwar, PhD

CONTACT

415-209-2072

vtanwar@buckinstitute.org

Study Locations (Sites)

The Buck Institute for Research on Aging

Novato, California, 94945

United States

Collaborators and Investigators

Sponsor: Buck Institute for Research on Aging

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2025-04-01

Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Postmenopause
Metabolism
Geroscience