Actively Recruiting

Phase Not Applicable
Age: 45Years - 65Years
FEMALE
ID06813261

A Randomized, Placebo-Controlled, Double-Blind Trial Investigating the Effects of GLYLO Supplement on Aging and Metabolic Health in Postmenopausal Women

Led by Buck Institute for Research on Aging · Updated on 2025-09-08

30

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the impact of GLYLO, a dietary supplement, in postmenopausal women aged 45 to 65 who are overweight or obese and have elevated HbA1c levels. The study aims to see if GLYLO can reduce harmful compounds called advanced glycation end products (AGEs), improve metabolic and hormonal health, and slow down age-related functional decline. Participants will be randomly assigned to take either GLYLO or a placebo for 24 weeks. The GLYLO group takes one capsule daily for the first week, then two capsules daily from week two onward. The study includes one screening visit and three testing visits over six months, with blood and urine samples collected, physical and cognitive tests performed, and questionnaires completed. During the study, participants will undergo assessments of body measurements, hormone levels, physical performance, and cognitive function. They will use a wearable device to track activity and complete diet questionnaires at the start and end of the study. Compliance is monitored by phone interviews, and safety is assessed throughout. The main outcomes measured are levels of methylglyoxal and AGEs at baseline, 12 weeks, and 24 weeks.

CONDITIONS

Brief Title

GLYLO Supplement Pilot Trial on Glycation and Aging in Postmenopausal Women

Who Can Participate

Age: 45Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults identified as female at birth with ovaries present (self-report)
  • Post menopause more than 1 year since last menses (self-report)
  • Aged 45 to 65 years
  • BMI 25 kg/m² or higher, or waist circumference 88 cm or more
  • HbA1c between 5.5% and 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
Not Eligible

You will not qualify if you...

  • Surgical menopause (self-report)
  • Hysterectomy and/or ovariectomy (self-report)
  • Receiving systemic hormone replacement therapy (HRT) (self-report); local vaginal estrogen therapy allowed
  • Use of weight loss medications within past 6 months or enrollment in weight loss program; weight must be stable within last 3 months
  • Regular use of GLYLO or supplements containing its ingredients within last 3 months
  • Diagnosis of diabetes (type 1 or 2), or use of hypoglycemic agents, or fasting glucose over 125 mg/dL
  • Elevated blood pressure (SBP ≥180 mmHg or DBP ≥100 mmHg) at screening
  • Use of psychotropic or other medications impacting weight unless stable for at least 6 months
  • Liver enzyme levels over twice normal limit
  • Immunosuppressive disorders or treatments
  • Active gastrointestinal bleeding or bleeding disorders within 6 months
  • Active peptic ulcer disease within 6 months
  • Active malignancy within 6 months except non-melanoma skin cancer not treated
  • Active infection within 1 month
  • Allergy to any supplement component
  • History of hyperthyroidism or thyroid cancer; abnormal thyroid function at screening
  • Unable to provide informed consent or comply safely with protocol
  • Active eating disorders
  • Active gout diagnosis
  • Recent changes to prescription medications affecting study results
  • No overnight hospitalization within 1 month
  • Any condition compromising safety or data quality per investigator judgment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants take GLYLO or placebo capsules daily for 12 weeks while completing various health and cognitive assessments, using a wearable device, and logging dietary intake and symptoms.

1 baseline visit and telephonic interviews at Weeks 2, 4, 6, 8, 10, and 14

Treatment

Duration - 12 weeks

Participants continue taking GLYLO or placebo capsules daily for an additional 12 weeks with ongoing assessments and compliance monitoring.

1 interim visit (3-month) plus telephonic interviews at Weeks 18 and 22

Follow-up

Duration - 1 day

Participants complete final health and cognitive assessments and return unused study products. They are asked to guess the treatment they received to assess blinding.

1 final visit (6-month)

Trial Site Locations

Total: 1 location

1

The Buck Institute for Research on Aging

Novato, California, United States, 94945

Actively Recruiting

Loading map...

Research Team

B

Brianna Stubbs, DPhil

V

Vineeta Tanwar, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

Similar Trials

Caloric Balance Markers (CaBooM) Study

Metabolism

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Advanced glycation end-products: pathway of potentially significant pathophysiological and therapeutic relevance for metabolic syndrome in menopausal women.

Zaher Merhi

https://pubmed.ncbi.nlm.nih.gov/24491162

The Role of Advanced Glycation End Products in Aging and Metabolic Diseases: Bridging Association and Causality.

Jyotiska Chaudhuri, Yasmin Bains, Sanjib Guha...

https://pubmed.ncbi.nlm.nih.gov/30184484