GLYLO Supplement for Postmenopausal Aging

(GRACE Trial)

Overseen By Brianna Stubbs, DPhil

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Buck Institute for Research on Aging

Must not be taking: Weight loss drugs, Hypoglycemics

Disqualifiers: Diabetes, Hypertension, Immunosuppressive, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 24 weeks

30 Participants Needed

Trial Summary

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 the GLYLO supplement safe for postmenopausal women?

There is no specific safety data available for GLYLO, but isoflavone supplements, which are similar, have been deemed safe for peri- and postmenopausal women by the European Food Safety Authority. ^{1 2 3 4 5}

How does the GLYLO treatment differ from other treatments for postmenopausal aging?

The GLYLO treatment is unique because it may involve novel ingredients or mechanisms not typically used in standard treatments for postmenopausal aging, such as specific bioactive compounds or phytonutrients that target aging-related pathways. Unlike traditional hormone replacement therapies, which can have systemic effects, GLYLO might offer a more targeted approach with potentially fewer side effects. ^{2 6 7 8 9}

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.

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

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Denmark pubmed.ncbi.nlm.nih.gov

[Isoflavones have therapeutic efficacy inoestrogen deficiency]. [2021]

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Bioactive compounds in the nutrition of peri- and postmenopausal women within the concept of 4P-medicine]. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of soy protein supplementation on serum lipoproteins, blood pressure, and menopausal symptoms in perimenopausal women. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Critical evaluation of the safety of Cimicifuga racemosa in menopause symptom relief. [2007]

5. England pubmed.ncbi.nlm.nih.gov

Long-term hormone therapy for perimenopausal and postmenopausal women. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Serum lipid-improving effect of soyabean β-conglycinin in hyperlipidaemic menopausal women. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Critical review of health effects of soyabean phyto-oestrogens in post-menopausal women. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Isoflavone supplements exert hormonal and antioxidant effects in postmenopausal Korean women with diabetic retinopathy. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Improvement of Biophysical Skin Parameters of Topically Applied Fermented Soybean Extract-Loaded Niosomes with No Systemic Toxicity in Ovariectomized Rats. [2021]