GLYLO Supplement for Postmenopausal Aging
(GRACE Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Buck Institute for Research on Aging

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for postmenopausal women aged 45 to 65 who are overweight or obese with high HbA1c levels, indicating elevated blood sugar. Participants must be willing to take capsules daily and provide blood and urine samples over a 6-month period.

Inclusion Criteria

HbA1c 5.7-6.4% (screening measurement)

I am between 45 and 65 years old.

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

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Exclusion Criteria

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)

I have had a hysterectomy and/or ovariectomy.

I have no active cancer except for non-melanoma skin cancer.

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Treatment Details

Interventions

GLYLO (Dietary Supplement)

Trial OverviewThe study tests if GLYLO, a dietary supplement, can lower harmful AGEs in the body, improve metabolic and hormonal health, and slow down age-related decline compared to a placebo. It involves taking two capsules daily for 24 weeks with regular testing visits.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: GLYLOExperimental Treatment1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

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.