GLYLO Supplement for Postmenopausal Aging

(GRACE Trial)

Overseen By Brianna Stubbs, DPhil

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Buck Institute for Research on Aging

Must not be taking: Weight loss drugs, Hypoglycemics

Disqualifiers: Diabetes, Hypertension, Immunosuppressive, others

Compensation: Varies

Number of Visits: 4

Duration: 24 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests GLYLO, a dietary supplement, to determine its effects on postmenopausal women who are overweight or obese with elevated blood sugar levels. Researchers aim to discover if GLYLO can reduce advanced glycation end products (AGEs), harmful compounds linked to aging and diseases. Participants will take either GLYLO or a placebo for 24 weeks to assess improvements in metabolic and hormonal health, as well as physical and cognitive functions. Women who are postmenopausal, have a BMI of 25 or higher, and elevated blood sugar levels may be suitable for this trial. As an unphased trial, this study allows participants to contribute to groundbreaking research on metabolic health.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it excludes those who have changed prescription medications within 3 months prior to the study if it might impact the results. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that GLYLO is likely to be safe for humans?

Research shows that GLYLO, a dietary supplement, contains ingredients such as benfotiamine, vitamin B6, nicotinamide, alpha lipoic acid, and piperine. The FDA considers these ingredients "generally recognized as safe" (GRAS), indicating they are typically safe for use in foods and supplements.

While specific safety studies on GLYLO itself are not available, similar supplements have been safely used by women during and after menopause. So far, no reports of serious side effects have emerged from the ingredients in GLYLO when taken in typical amounts. However, as with any supplement, individual reactions can vary. It is always advisable to monitor any changes and consult a healthcare provider if concerns arise. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for postmenopausal aging that often focus on hormone replacement or calcium and vitamin D supplements, GLYLO offers a novel approach by targeting glycation, a process that contributes to aging and various age-related conditions. GLYLO is a blend of glycation-lowering compounds, including benfotiamine, a fat-soluble form of vitamin B1, and alpha-lipoic acid, both known for their antioxidant properties. Researchers are excited because these ingredients are generally recognized as safe by the FDA and could potentially slow down aging in a way that's different from existing therapies.

What evidence suggests that GLYLO might be an effective treatment for postmenopausal aging?

This trial will compare GLYLO with a placebo to evaluate its effects on postmenopausal aging. Research suggests that GLYLO may help reduce harmful compounds known as advanced glycation end products (AGEs). These compounds form when sugar attaches to proteins or fats in the body and can contribute to aging and disease. In animal studies, GLYLO helped mice eat less and improved their insulin use. These effects suggest it might enhance metabolic health and slow aging. Although human studies provide limited information, these early findings offer hope for potential benefits in postmenopausal women. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive GLYLO or placebo for 24 weeks, with assessments at baseline, 3 months, and 6 months

24 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GLYLO

Trial Overview The 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.

How Is the Trial Designed?

Group I: GLYLO Experimental Treatment 1 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: Placebo Placebo Group 1 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.

Who Is Running the Clinical Trial?

Buck Institute for Research on Aging

Lead Sponsor

Trials

6

Recruited

1,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06813261

GLYLO Supplement Pilot Trial on Glycation and Aging in ... 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 ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06813261/glylo-supplement-pilot-trial-on-glycation-and-aging-in-postmenopausal-women?state=CA&city=Novato

GLYLO Supplement Pilot Trial on Glycation and Aging in ... The primary outcome of the study is to determine if GLYLO reduces AGEs, enhances metabolic and hormonal health, and mitigates age-related ...

3. trialx.com trialx.com/clinical-trials/listings/300694/glylo-supplement-pilot-trial-on-glycation-and-aging-in-postmenopausal-women/

GLYLO Supplement Pilot Trial on Glycation and Aging in ... 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 ...

4. withpower.com withpower.com/trial/glylo-supplement-for-postmenopausal-aging-559c7

GLYLO Supplement for Postmenopausal Aging The primary outcome of the study is to determine if GLYLO reduces AGEs, enhances metabolic and hormonal health, and mitigates age-related functional decline.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06242535

NCT06242535 | Pilot Study of GLY-LOW Supplementation ... GLY-LOW supplementation reduced caloric intake and increased insulin sensitivity in mice. In female mice, GLY-LOW supplementation reversed aging-related ...

6. ctv.veeva.com ctv.veeva.com/study/glylo-supplement-pilot-trial-on-glycation-and-aging-in-postmenopausal-women

GLYLO Supplement Pilot Trial on Glycation and Aging in ... The aim of this study is to assess the effectiveness of GLYLO, a dietary supplement, in postmenopausal women aged 45 to 65 who are ...