GLYLO Supplement Pilot Trial on Glycation and Aging in Postmenopausal Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorBuck Institute for Research on Aging
About 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 does not accept healthy volunteersQualifiers
Adults identified as female at birth with ovaries present (self-report)
Post menopause >1y since last menses (self-report)
Aged 45 - 65 y
BMI ≥ 25 kg/m², based on self-reported weight and height
Disqualifiers
Surgical menopause (self-report)
Hysterectomy and/or ovariectomy (self-report)
Receiving systematic hormone replacement therapy (HRT) (self-report). Use of local vaginal estrogen therapy (e.g., estrogen creams, vaginal tablets, or estrogen rings such as Estring) is permitted.
Currently prescribed or received weight loss medications within the past 6 months or currently enrolled in a defined weight loss program. Weight must be stable (> 4%) within the last 3 months.
Trial design
Design model
Parallel
Treatments tested in this trial
GLYLO
Other interventioncommercially 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 interventionVisually 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: GLYLOExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Methylglyoxal (MGO)
MGO is a reactive dicarbonyl compound, measured by biochemical assays such as high-performance liquid chromatography (HPLC) or liquid chromatography-mass spectrometry (LC-MS) . The concentration of MGO is quantified to assess its role in the formation of advanced glycation end products (AGEs). Change is measured across the study
Time frame
Baseline, Week 12, Week 242
Advance glycation end products (AGE)
Measurement of circulating and tissue-bound AGE will be measure by either HPLC or LC-MS. Change is measured across the study
Time frame
Baseline, Week 12, Week 24Secondary outcomes
1
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
This is calculated by the formula HOMA-IR = (Fasting Insulin \* Fasting Glucose) / 405, using fasting glucose and insulin levels. It is a marker of insulin resistance, reflecting metabolic health. Change is measured across the study
Time frame
Baseline, Week 12, Week 242
HbA1c
HbA1c is measured through immunoassay techniques, indicating average blood glucose levels over the previous 2-3 months, which is a crucial marker for long-term glucose control. Change is measured across the study
Time frame
Baseline, Week 12, Week 243
Body fat
Bioelectrical impedance analysis (BIA) is used to assess body composition, measuring fat mass. BIA calculates resistance and reactance, allowing for an estimate of body fat and lean tissue. Change is measured across the study
Time frame
Baseline, Week 12, Week 244
Body mass index (BMI)
Calculation of BMI by dividing weight (kg) by height (m²). Change is measured across the study
Time frame
Baseline, Week 12, Week 24Other outcomes
1
Retinal age
Retinal age is estimated using non-invasive retinal imaging techniques, such as optical coherence tomography (OCT) or fundus photography, and assessed via image analysis tools to estimate biological age based on retinal features. Change is measured across the study
Time frame
Baseline, Week 12, Week 242
Pulse wave velocity (PWV)
PWV is measured non-invasively using devices that record the speed of the blood pressure wave traveling through arteries, typically using applanation tonometry or oscillometric techniques. This reflects arterial stiffness and cardiovascular health. Change is measured across the study
Time frame
Baseline, Week 12, Week 243
Skin autofluorescence for measuring AGEs
Skin autofluorescence will be measured using the AGE Reader, DiagnOptics, which emits light at specific wavelengths and measures the amount of fluorescence emitted from the skin, correlating with AGE accumulation in tissues. Change is measured across the study
Time frame
Baseline, Week 12, Week 244
Metabolomic analysis
Comprehensive profiling of metabolites in blood is conducted using LC-MS to identify biomarkers associated with metabolic health. Change is measured across the study
Time frame
Baseline, Week 12, Week 24Sponsors and contacts
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Source ClinicalTrials.gov