GLYLO Supplement Pilot Trial on Glycation and Aging in Postmenopausal Women

Part of paid clinical trials in Novato, California.

Sponsor
Buck Institute for Research on Aging
Study ID
NCT06813261
Status
Recruiting
Apply to this trial

Conditions

  • Geroscience
  • Metabolism
  • Postmenopause

Eligibility Criteria

Sex
FEMALE
Age
45 Years - 65 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Apr 1, 2025
Status verified
Sep 2025
Primary completion
Apr 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: GLYLO
    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.
  • Placebo Comparator: Placebo
    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.

Primary Outcome Measure

Methylglyoxal (MGO) [ Time Frame: Baseline, Week 12, Week 24 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Buck Institute for Research on AgingNovatoCalifornia94945
Vineeta Tanwar, PhD
[email protected]
(415) 209-2072
Chatura Senadheera, MSc
[email protected]
4152092072
Brianna Stubbs, DPhil (PRINCIPAL_INVESTIGATOR)

Find similar trials in Novato, CA

By research site
The Buck Institute for Research on Aging· Novato, CA

Related Studies