Pilot Study of GLY-LOW Supplementation in Postmenopausal Women With Obesity

NCT06242535 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: BRANY IRB # 23-02-452-1498
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

A combination of generally regarded as safe (GRAS) compounds named GLY-LOW, which included: alpha lipoic acid, pyridoxamine, nicotinamide, piperine and thiamine, were examined in pre-clinical experiments. GLY-LOW supplementation reduced caloric intake and increased insulin sensitivity in mice. In female mice, GLY-LOW supplementation reversed aging-related declines in female hormones. Studies in humans are needed to examine the feasibility, utility and efficacy of GLY-LOW supplementation in post-menopausal women with obesity toward improving aging-related impairments. The effect of GLY-LOW supplementation on these obesity and biological age-related impairments in post-menopausal adult female humans with obesity is unknown. We aim to translate the findings of GLY-LOW supplementation in animals to a cohort of healthy, postmenopausal females at birth with obesity by conducting a one-group, no-placebo comparer, pre post intervention clinical trial. Additionally, we propose to examine the specific effect of supplementation by GLY-LOW on biological aging via retina scan. The objectives of the proposed pilot study are: I. Conduct a 6-month pilot study to examine the feasibility, utility and efficacy of GLY-LOW supplementation in a total of 40 postmenopausal female born adults \> 55 years with obesity (≥ 30 BMI).

Conditions

Insulin Resistance; Obesity; Cardiovascular Diseases; Cognitive Impairment; Physical Disability; Depression; Inflammation; Hormone Deficiency; Physical Inactivity; Hyperlipidemias; Hypertension; Overeating

Keywords

nutrition supplement

Outcome Measures

Primary Outcomes (5)

• Insulin Resistance (IR)

  Measured by examining biochemical markers using samples of whole blood obtained in a certified laboratory. . Study participants will be required to fast for 12 hours prior to the blood test. Blood collection and processing: Venous blood will be collected in the morning after a 12 hour fast with the study participant seated. Blood will be collected in tubes containing 1.5 mg/ml EDTA for procedures requiring plasma, in tubes with no additives for serum measures and citrate tubes for homeostasis endpoints.

  During the screening/baseline visit and again during the 6-month follow-up visit.

• Fasting Insulin (I) and Glucose (G)

  Measured by examining biochemical markers using samples of whole blood obtained in a certified laboratory. . Study participants will be required to fast for 12 hours prior to the blood test. Blood collection and processing: Venous blood will be collected in the morning after a 12 hour fast with the study participant seated. Blood will be collected in tubes containing 1.5 mg/ml EDTA for procedures requiring plasma, in tubes with no additives for serum measures and citrate tubes for homeostasis endpoints.

  During the screening/baseline visit and again during the 6-month follow-up visit.

• Glycosylated Hemoglobin [Hemoglobin A1C (HBA1C)]

  Measured by examining biochemical markers using samples of whole blood obtained in a certified laboratory. . Study participants will be required to fast for 12 hours prior to the blood test. Blood collection and processing: Venous blood will be collected in the morning after a 12 hour fast with the study participant seated. Blood will be collected in tubes containing 1.5 mg/ml EDTA for procedures requiring plasma, in tubes with no additives for serum measures and citrate tubes for homeostasis endpoints.

  During the screening/baseline visit and again during the 6-month follow-up visit.

• BMI [weight (kg) divided by height (m2)]

  Total body weight and height were measured with an electronically calibrated scale and stadiometer (Pelstart Health-o-meter Professional 500KL) with participants in light, loose fitting clothing without shoes.

  During the screening/baseline visit and again during the 6-month follow-up visit.

• Body Composition [lean mass, fat mass, bone density and area, central adiposity (DEXA); waist circumference]

  DEXA will be used for analysis of body composition using Hologics Horizon A DEXA. This machine is an FDA cleared-to market device. The procedure will be performed by trained technicians at the Hoskinson Health and Wellness Clinic. The study participants will be instructed to remove all metal and jewelry including their shoes before they are correctly positioned on the scan table, lying down on their back with their arms to their side. The DEXA will measure X-rays as they are transmitted through the study participant's body. The study participant will be exposed to ionizing radiation, but there is no discomfort during the measurement (0.02-0.03mR). This exposure is less than the 125mR/yr, which is the amount individuals receive from non-medical background radiation (Lunar). The low dose of radiation will not adversely affect the bone or surrounding tissue.

  During the screening/baseline visit and again during the 6-month follow-up visit.

Secondary Outcomes (17)

• Self-reported Caloric Intake

  During the screening/baseline visit and again during the 6-month follow-up visit.

• Total Cholesterol, Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL) and Triglycerides (TRI)

  During the screening/baseline visit and again during the 6-month follow-up visit.

• Systolic (SBP) and Diastolic Blood Pressure (DPB)

  During the screening/baseline visit and again during the 6-month follow-up visit.

• Metabolic Assessments at Rest

  During the screening/baseline visit and again during the 6-month follow-up visit.

• Thyroid Stimulating Hormone (TSH), Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estrogen (E) and Progesterone (P4)

  During the screening/baseline visit and again during the 6-month follow-up visit.

Other Outcomes (2)

• Safety Outcomes

  During the screening/baseline visit, 2-, 4-, and 6-month follow-up visits.

• Subject adherence

  During 2-, 4-, and 6-month follow-up visits.

Study Arms (1)

GLY-LOW supplement

EXPERIMENTAL

Each participant will take this supplement daily in a pill form orally once in the morning. The test product will be two capsules a day with breakfast between 7:00 - 11:00 AM. The chosen doses were based on dose conversion from mice to humans and the prior data on safety for each of the compounds in humans.

Biological: GLY-LOW

Interventions

GLY-LOW BIOLOGICAL

This supplement is available for over-the-counter purchase. Each capsule is a combination of vitamins and natural products: Vitamin B1 (100mg); Vitamin B6 (50mg); Niacin (200mg); Alpha Lipoic Acid (150mg); and Piperine (15mg). The supplement, GLY-LOW, is FDA approved for use as a dietary supplement (IND 162006)

Also known as: GLYLO

GLY-LOW supplement

Eligibility Criteria

• Age: 56 Years+
• Gender Eligibility Details: Post-menopausal (\>1 year from last menstrual cycle) adult females (at birth), \>55 years of age with obesity (BMI ≥ 30)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-menopausal (\>1 year from last menstrual cycle) adult females (at birth) \>55 years of age with obesity (BMI ≥ 30)

You may not qualify if:

• Males
• Adults not females at birth
• Adult females diagnosed with Gout
• Adult females receiving hormone replacement therapy (HRT)
• Adult females who are currently prescribed or received weight loss medications within the past 6 months, or currently enrolled in a defined weight loss program.
• Adult females with cardio-metabolic disease \[e.g. cardiovascular disease (CVD), type 2 diabetes (T2DM), hypertension, h/o stroke etc.)\] requiring any prescription medication.
• Adult females with other chronic immune, pulmonary, neurodegenerative or systemic disease requiring prescription medication
• Adult females with severe asthma based upon American Thoracic Society (ATS) standards and/or NIH guidelines.
• Adult females requiring monoclonal antibody or biological treatment
• Adult females diagnosed with an acute lower respiratory or GI infection within 2 weeks
• Adult females who are pregnant (would not qualify as post-menopausal) or nursing mothers
• Adult females reporting moderate to severe mental or physical disability
• Adult females reporting unwillingness to travel to onsite clinical facilities
• Adult females with moderate to severe cognitive impairment
• Adult females diagnosed with an eating disorder

Sponsors & Collaborators

• Hoskinson Health and Wellness Clinic: lead
• Buck Institute for Research on Aging: collaborator
• University of Wyoming: collaborator

Study Sites (1)

Hoskinson Health and Wellness Clinic

Gillette, Wyoming, 82718, United States

Location

Related Publications (11)

• Hoskinson W, Sothern M, Thompson T, et al. 516 Follicle-stimulating hormone is reduced following a novel nutritional therapeutic in postmenopausal women with obesity. Journal of Clinical and Translational Science. 2025;9(s1):151-152. doi:10.1017/cts.2024.1097

  BACKGROUND

• O'Hearn M, Lara-Castor L, Cudhea F, Miller V, Reedy J, Shi P, Zhang J, Wong JB, Economos CD, Micha R, Mozaffarian D; Global Dietary Database. Incident type 2 diabetes attributable to suboptimal diet in 184 countries. Nat Med. 2023 Apr;29(4):982-995. doi: 10.1038/s41591-023-02278-8. Epub 2023 Apr 17.

  PMID: 37069363 BACKGROUND

• Jayedi A, Soltani S, Motlagh SZ, Emadi A, Shahinfar H, Moosavi H, Shab-Bidar S. Anthropometric and adiposity indicators and risk of type 2 diabetes: systematic review and dose-response meta-analysis of cohort studies. BMJ. 2022 Jan 18;376:e067516. doi: 10.1136/bmj-2021-067516.

  PMID: 35042741 BACKGROUND

• Noubiap JJ, Nansseu JR, Lontchi-Yimagou E, Nkeck JR, Nyaga UF, Ngouo AT, Tounouga DN, Tianyi FL, Foka AJ, Ndoadoumgue AL, Bigna JJ. Geographic distribution of metabolic syndrome and its components in the general adult population: A meta-analysis of global data from 28 million individuals. Diabetes Res Clin Pract. 2022 Jun;188:109924. doi: 10.1016/j.diabres.2022.109924. Epub 2022 May 15.

  PMID: 35584716 BACKGROUND

• Nappi RE, Chedraui P, Lambrinoudaki I, Simoncini T. Menopause: a cardiometabolic transition. Lancet Diabetes Endocrinol. 2022 Jun;10(6):442-456. doi: 10.1016/S2213-8587(22)00076-6. Epub 2022 May 4.

  PMID: 35525259 BACKGROUND

• Brennan AM, Standley RA, Yi F, Carnero EA, Sparks LM, Goodpaster BH. Individual Response Variation in the Effects of Weight Loss and Exercise on Insulin Sensitivity and Cardiometabolic Risk in Older Adults. Front Endocrinol (Lausanne). 2020 Sep 10;11:632. doi: 10.3389/fendo.2020.00632. eCollection 2020.

  PMID: 33013705 BACKGROUND

• Tamura Y, Omura T, Toyoshima K, Araki A. Nutrition Management in Older Adults with Diabetes: A Review on the Importance of Shifting Prevention Strategies from Metabolic Syndrome to Frailty. Nutrients. 2020 Nov 1;12(11):3367. doi: 10.3390/nu12113367.

  PMID: 33139628 BACKGROUND

• Chaudhuri J, Bains Y, Guha S, Kahn A, Hall D, Bose N, Gugliucci A, Kapahi P. The Role of Advanced Glycation End Products in Aging and Metabolic Diseases: Bridging Association and Causality. Cell Metab. 2018 Sep 4;28(3):337-352. doi: 10.1016/j.cmet.2018.08.014.

  PMID: 30184484 BACKGROUND

• Chaudhuri J, Bose N, Gong J, Hall D, Rifkind A, Bhaumik D, Peiris TH, Chamoli M, Le CH, Liu J, Lithgow GJ, Ramanathan A, Xu XZS, Kapahi P. A Caenorhabditis elegans Model Elucidates a Conserved Role for TRPA1-Nrf Signaling in Reactive alpha-Dicarbonyl Detoxification. Curr Biol. 2016 Nov 21;26(22):3014-3025. doi: 10.1016/j.cub.2016.09.024. Epub 2016 Oct 20.

  PMID: 27773573 BACKGROUND

• Zee T, Bose N, Zee J, Beck JN, Yang S, Parihar J, Yang M, Damodar S, Hall D, O'Leary MN, Ramanathan A, Gerona RR, Killilea DW, Chi T, Tischfield J, Sahota A, Kahn A, Stoller ML, Kapahi P. alpha-Lipoic acid treatment prevents cystine urolithiasis in a mouse model of cystinuria. Nat Med. 2017 Mar;23(3):288-290. doi: 10.1038/nm.4280. Epub 2017 Feb 6.

  PMID: 28165480 BACKGROUND

• Zhu Z, Liu D, Chen R, Hu W, Liao H, Kiburg K, Ha J, He S, Shang X, Huang Y, Wang W, Yu H, Yang X, He M. The Association of Retinal age gap with metabolic syndrome and inflammation. J Diabetes. 2023 Mar;15(3):237-245. doi: 10.1111/1753-0407.13364. Epub 2023 Mar 14.

  PMID: 36919192 BACKGROUND

MeSH Terms

Conditions

Insulin Resistance; Obesity; Cardiovascular Diseases; Cognitive Dysfunction; Depression; Inflammation; Sedentary Behavior; Hyperlipidemias; Hypertension; Hyperphagia

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Pathologic Processes; Dyslipidemias; Lipid Metabolism Disorders; Vascular Diseases; Signs and Symptoms, Digestive

Study Officials

• Sanjay Dhar, PhD

  Hoskinson Health and Wellness Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Model Details: One group, no-placebo comparer, pre post intervention clinical trial

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 5, 2024
• Study Start: July 27, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)