Reduction of glycation stress as a geroscience intervention: protocol for a pilot RCT in postmenopausal women.
Vineeta Tanwar, Pankaj Kapahi, John C Newman...
https://pubmed.ncbi.nlm.nih.gov/42026060/Actively Recruiting
Led by Buck Institute for Research on Aging · Updated on 2025-09-08
30
Participants Needed
1
Research Sites
8 weeks
Total Duration
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
GLYLO Supplement Pilot Trial on Glycation and Aging in Postmenopausal Women
B
Brianna Stubbs, DPhil
V
Vineeta Tanwar, PhD
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Buck Institute for Research on Aging
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | GLYLO supplement | Placebo capsule |
|---|---|---|
| What it is | GLYLO is a commercially available supplement containing a mixture of glycation-lowering compounds, including benfotiamine, vitamin B6, nicotinamide, alpha lipoic acid, and piperine. It is recognized as safe for use and provided in capsule form. | A visually matched capsule containing inert microcrystalline cellulose, designed to replicate GLYLO in appearance but without active glycation-lowering components. |
| Role in trial | Active intervention arm, assigned to receive GLYLO supplement. | Comparator arm, assigned to receive placebo capsule. |
| Primary use | Being investigated for its potential to reduce glycation levels and related metabolic markers in postmenopausal women. | Serves as a control for assessing any changes attributable to GLYLO supplementation. |
| How it is given or performed | Capsule taken orally—one capsule daily after breakfast during the first week, then two capsules daily after meals for the remainder of study. | Oral capsule matched to GLYLO, taken with the same schedule—one daily after breakfast in week one, then two daily for the remainder. |
| Evidence status | No published clinical outcome evidence yet for GLYLO in glycation or metabolic markers in postmenopausal women; ongoing randomized clinical investigation. | No evidence supports placebo effectiveness in reducing glycation or metabolic markers; serves as control only. |
| Important limitations | GLYLO supplement efficacy and safety are currently being studied in a small pilot population; no outcome data are established. Effects on glycation and metabolic outcomes remain theoretical until results are available. | Placebo control does not affect glycation; study sample size is limited and placebo findings cannot inform metabolic improvement. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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)
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Lead Sponsor